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The use of a dietary supplement combination and an essential fatty acid as an alternative and complementary treatment for children with Attention Deficit Hyperactivitiy Disorder (ADHD)

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The use of a dietary supplement combination and an essential fatty acid as an alternative and complementary treatment for children with Attention Deficit Hyperactivitiy Disorder (ADHD)
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Brue, Alan W
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ix, 261 leaves : ; 29 cm.

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Attention deficit disorder ( jstor )
Attention deficit hyperactivity disorder ( jstor )
Child psychology ( jstor )
Dietary supplements ( jstor )
Essential fatty acids ( jstor )
Hyperactivity ( jstor )
Medications ( jstor )
Parents ( jstor )
Placebos ( jstor )
Symptomatology ( jstor )
Dissertations, Academic -- Foundations of Education -- UF ( lcsh )
Foundations of Education thesis, Ph.D ( lcsh )
City of Orlando ( local )
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bibliography ( marcgt )
non-fiction ( marcgt )

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Thesis:
Thesis (Ph.D.)--University of Florida, 1999.
Bibliography:
Includes bibliographical references (leaves 211-259).
General Note:
Typescript.
General Note:
Vita.
Statement of Responsibility:
by Alan W. Brue.

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University of Florida
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Copyright [name of dissertation author]. Permission granted to the University of Florida to digitize, archive and distribute this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.
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42450629 ( OCLC )
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THE USE OF A DIETARY SUPPLEMENT COMBINATION AND AN ESSENTIAL
FATTY ACID AS AN ALTERNATIVE AND COMPLEMENTARY TREATMENT FOR
CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
(ADHD)
















By

ALAN W. BRUE


A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY

UNIVERSITY OF FLORIDA


1999




THE USE OF A DIETARY SUPPLEMENT COMBINATION AND AN ESSENTIAL
FATTY ACID AS AN ALTERNATIVE AND COMPLEMENTARY TREATMENT FOR
CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
(ADHD)
By
ALAN W. BRUE
A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY
UNIVERSITY OF FLORIDA
1999


ACKNOWLEDGMENTS
Thank you to my doctoral committee members for their
assistance during the completion of this dissertation,
especially my committee chair, Dr. Thomas Oakland, for his
help and guidance throughout my graduate studies. His
untiring work ethic is an inspiration. Drs. John Kranzler,
Mary Kay Dykes, and Barry Guinagh were helpful and
supportive. Their insightful comments were very useful in
preparing my dissertation, and I appreciate their
assistance.
Thanks to Dr. Robert Evans, Bonnie Snyder, and other
members of the study team for their assistance throughout
this project. And special thanks to the children, parents,
and teachers who participated in the study, for without them
this research would not have been possible.
Most of all I would like to thank my friends and
family, and especially my wife, Dawn, for their support
throughout my graduate studies.
11


TABLE OF CONTENTS
Page
ACKNOWLEDGMENTS
LIST OF TABLES vi
ABSTRACT ix
CHAPTERS
ONE INTRODUCTION 1
Statement of the Problem 1
Purpose of the Study 3
Procedures 3
Trial I Hypotheses 6
Trial II Hypotheses 7
Overview 8
TWO REVIEW OF RELATED LITERATURE 10
Historical Views 10
Theoretical Views 11
Characteristics 13
Prevalence 15
Incidence 17
Etiology 18
Diagnosis 32
Assessment 37
Problems Associated with ADHD Symptoms 44
Pharmacological Intervention 50
Reasons For Not Using Medication as an Initial
Treatment 56
Combining Medication with Other Interventions... 57
Opposition to the Use of Medications 59
Alternative Treatments 69
in


Classroom- and Home-based Interventions 91
Purpose of the Study 107
THREE METHODOLOGY 109
Selection of Participants 112
Procedures 114
Instrumentation 117
Assignment of Participants 123
Treatments 124
Administration 128
Trial I Hypotheses 129
Trial II Hypotheses 130
Data Analysis Procedures 132
FOUR ANALYSIS OF THE DATA 134
Trial I Results 134
Trial II Results 141
Additional Findings 150
FIVE DISCUSSION AND RECOMMENDATIONS 155
Discussion of the Results 155
Study Limitations 167
Recommendations for Future Research 170
APPENDICES
A ADHD RESEARCH PROTOCOL 172
B ORLANDO REGIONAL HEALTHCARE SYSTEM
INSTITUTIONAL REVIEW BOARD FACT SHEET 182
C ORLANDO REGIONAL HEALTHCARE SYSTEM
INSTITUTIONAL REVIEW BOARD APPROVAL 187
D UNIVERSITY OF FLORIDA INSTITUTIONAL REVIEW
BOARD APPROVAL 190
E STUDY PARTICIPANT INFORMATION FORM 192
F INFORMED CONSENT FORM 204
iv


REFERENCES 211
BIOGRAPHICAL SKETCH 260
v


LIST OF TABLES
Table Page
1 Feingold Diet, Stage 1 72
2 Feingold Diet, Stage 2 74
3 Application of and Results from Neurofeedback
Treatment 80
4 Effective Interventions for Children with
Attention Deficits 93
5 DSM-IV Criteria for a Diagnosis of ADHD,
Combined Type 110
6 Participants by Assignment, Age Group, and
Gender After Attrition 112
7 Parent and Teacher Data Collections by
Participants' Age Group and Gender 115
8 DSM-IV: Inattentive Subscale Items from the
CRS-R: L 116
9 DSM-IV: Hyperactive-Impulsive Subscale Items
from the CRS-R:L 118
10 Psychometric Properties of the CRS-R:L 122
11 Number and Mean Age of Participants in Each
Group After Attrition 124
12 Trial I Parent Results From the DSM-IV:
Inattentive Subscale for Children Not Taking
Ritalin 135
vi


13
14
15
16
17
18
19
20
21
22
23
135
136
137
138
139
140
141
142
143
144
146
Trial I Teacher Results From the DSM-IV:
Inattentive Subscale for Children Not Taking
Ritalin
Trial I Parent Results From the DSM-IV:
Inattentive Subscale for Children Taking
Ritalin
Trial I Teacher Results From the DSM-IV:
Inattentive Subscale for Children Taking
Ritalin
Trial I Parent Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Not Taking Ritalin
Trial I Teacher Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Not Taking Ritalin
Trial I Parent Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Taking Ritalin
Trial I Teacher Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Taking Ritalin
Trial II Parent Results From the DSM-IV:
Inattentive Subscale for Children Not Taking
Ritalin
Trial II Teacher Results From the DSM-IV:
Inattentive Subscale for Children Not Taking
Ritalin
Trial II Parent Results From the DSM-IV:
Inattentive Subscale for Children Taking
Ritalin
Trial II Teacher Results From the DSM-IV:
Inattentive Subscale for Children Taking
Ritalin
Vll


24
Trial II Parent Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Not Taking Ritalin 147
25 Trial II Teacher Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Not Taking Ritalin 148
26 Trial II Parent Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Taking Ritalin 149
27 Trial II Teacher Results From the DSM-IV:
Hyperactive-Impulsive Subscale for Children
Taking Ritalin 150
28 Ritalin vs. Non-Ritalin Group Comparisons for
the DSM-IV: Inattentive and DSM-IV:
Hyperactive-Impulsive Subscales 152
29 Treatment vs. Control Group Comparisons for the
DSM-IV: Inattentive and DSM-IV: Hyperactive-
Impulsive Subscales 154
viii


Abstract of Dissertation Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Doctor of Philosophy
THE USE OF A DIETARY SUPPLEMENT COMBINATION AND AN ESSENTIAL
FATTY ACID AS AN ALTERNATIVE AND COMPLEMENTARY TREATMENT FOR
CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
(ADHD)
By
Alan W. Brue
August 1999
Chairman: Thomas D. Oakland, Ph.D.
Major Department: Foundations of Education
The study investigated the efficacy of the use of a
dietary supplement combination (i.e., Ginkgo biloba, Melissa
officinalis, Grapine, dimethylaminoethanol, and L-Glutamine)
and an essential fatty acid (i.e., flaxseed) as a treatment
for qualities relevant to attention deficit hyperactivity
disorder (ADHD) (i.e., inattentiveness and hyperactivity-
impulsivity). Its goal was to provide empirical evidence
regarding their effectiveness in reducing ADHD-related
behaviors in children diagnosed with this disorder.
Sixty participants initially were chosen to participate
in two 12-week trials. Thirty participants were chosen
IX


randomly from those not taking Ritalin, and thirty
participants were chosen randomly from those taking Ritalin.
After attrition, fifty-one children completed both trials,
among whom 25 were in the non-Ritalin group and 26 were in
the Ritalin group.
During Trial I, the dietary supplement combination was
not more effective than a placebo at ameliorating children's
inattentiveness and hyperactivity-impulsivity. Results from
Trial II were mixed. Among children taking Ritalin, those
who received the double dietary supplement combination
displayed less inattentive behaviors than those who received
the double dietary supplement combination plus an essential
fatty acid based on teacher reports. Also, among children
not taking Ritalin, those who received the double dietary
supplement combination plus an essential fatty acid
displayed less hyperactive-impulsive behaviors than those
who received the double dietary supplement combination based
on parent reports. However, those who received the double
dietary supplement combination displayed less hyperactive-
impulsive behaviors than those who received the double
dietary supplement combination plus an essential fatty acid
based on teacher reports. Thus, these ingredients may not be
x


a reliable and effective alternative to or complementary
treatment of ADHD.
xi


CHAPTER ONE
INTRODUCTION
Most children are active, energetic, and move from one
activity to the next. They may become bored easily with
tasks offering no reward, and often require considerable
self-discipline to sit still and finish them. However, some
children live in a world of disorganized and frenzied
activities. They display levels of activity that far exceed
their age group. Their ability to sustain interest or
persistence as well as their peers is a challenge. Many
of these children have been diagnosed with an attention
deficit hyperactivity disorder (ADHD).
Statement of the Problem
Stimulant medication (e.g., Ritalin, Dexedrine, Cylert)
is the most commonly used treatment for ADHD (Epstein,
Singh, Luebke, & Stout, 1991). Ritalin is prescribed in more
than 90% of children with ADHD who receive stimulant
medication (DuPaul & Stoner, 1994; Goldman, Genel, Bezman, &
Slanetz, 1998). The number of people taking Ritalin doubled
between 1993 and 1995, and about three-fourths of the 2.6
1


2
million consumers of Ritalin are children aged 5 to 12 with
ADHD (Price, 1996). The United States Drug Enforcement
Administration (DEA) has expressed alarm at the large
increase in the number of prescriptions for stimulant
medications in recent years (Haislip, 1996).
While 70% to 80% of the children taking stimulant
medications will find them somewhat effective (Buncher,
1996), the majority will experience mild to severe adverse
drug reactions (Efron, Jarman, & Barker, 1997) Severe
adverse reactions may include liver dysfunction (Barkley,
1995; Jordan, 1998; Tan & Schneider, 1997), glaucoma
(Armstrong, 1995), symptoms of psychosis (Braswell &
Bloomquist, 1991), anorexia (Physicians' Desk Reference,
1999), heart problems leading to sudden death (Armstrong,
1995), and permanent facial tics (Breggin & Breggin, 1995;
Reichenberg-Ullman & Ullman, 1996; Tan & Schneider, 1997).
Parents increasingly are seeking effective, natural
alternative or complementary treatments for their children
with ADHD. Many do not wish to expose their children to
medications whose adverse reactions may lead to irreversible
health problems. The Physicians' Desk Reference (1999)
acknowledges there are insufficient data on the safety of
long-term stimulant use by children.


3
Purpose of the Study
The purpose of this study was to investigate the
efficacy of the use of a dietary supplement combination
(i.e., Ginkgo biloba, Melissa officinalis, Grapine,
dimethylaminoethanol, and L-Glutamine) and an essential
fatty acid (i.e., flaxseed) as a treatment for qualities
relevant to ADHD (i.e., inattentiveness and hyperactivity-
impulsivity). Its goal was to provide empirical evidence
with respect to their effectiveness in treating children
with this disorder.
Procedures
Parents of children ages 4 through 12 were invited as
potential participants. They were self-referred or referred
by pediatricians, psychologists, psychiatrists, or
educators. Children were required to have a previous
diagnosis of ADHD, Combined Type as established by the
Diagnostic and Statistical Manual of Mental Disorders, 4th
Edition (DSM-IV) (American Psychiatric Association, 1994).
Those receiving medication for their ADHD must have been
taking Ritalin.
Parents of candidates completed a Study Participant
Information Form. This form was used to obtain information
in many areas, including developmental, medical, and


4
nutritional histories. Those candidates with other pre
existing diagnoses (e.g., asthma, depression) were not
considered, as pre-existing conditions often require regular
use of medication as a treatment.
Sixty candidates initially were chosen to participate.
Thirty participants were chosen randomly from those not
taking Ritalin, and thirty participants were chosen randomly
from those taking Ritalin. The medical record of each
participant was reviewed by the study physicians. Parents of
children whose primary care physician were treating them
were asked to request a blood analysis and to provide a copy
of the child's last physical examination. Participants
taking Ritalin continued to receive it as prescribed by
their physicians.
It was explained to parents that they could withdraw
their child from the study at any time. Parents also were
told to notify the physician in charge of the study if their
child's Ritalin dosage was modified or if medication was
changed from Ritalin to any other medication to treat ADHD.
These conditions led to an administrative withdrawal of
children from the study.
Participants' parents were asked to complete a Conners'
Parent Rating Scale-Revised: Long Form (Conners, 1997a). The


5
teachers with whom participants spent most of their school
day were asked to complete a Conners' Teacher Rating Scale-
Revised: Long Form (Conners, 1997a).
The intervention consisted of two 12-week trials,
hereafter called Trial I and Trial II. Within each trial
were two experimental and two control groups. Prior to the
beginning of Trial I, participants not taking Ritalin were
assigned randomly to either the non-Ritalin treatment group
or the non-Ritalin control group. Participants taking
Ritalin were assigned randomly to either the Ritalin
treatment group or the Ritalin control group.
During Trial I, participants in the treatment groups
received a dietary supplement combination with the following
ingredients and dosages: Ginkgo biloba 10 mg, Melissa
officinalis 200 mg, Grapine 30 mg, dimethylaminoethanol 35
mg, and L-Glutamine 100 mg. Participants in the control
groups received an inactive slippery elm supplement (220 mg)
as a placebo.
Trial II was implemented following the completion of
Trial I, using the same subjects from the first trial.
Subjects remained in their cohort group; only the treatment
changed. During Trial II, all participants received a
dietary supplement combination whose concentration was


6
doubled. Additionally, the two treatment groups (formerly
control groups) received an essential fatty acid (i.e.,
flaxseed) with their combination. The double dietary-
supplement combination, a uniform intervention received by
all participants, helped to detect any significant
differences in the groups of participants who received this
essential fatty acid.
Nine children were withdrawn from the study during
Trial I. The reasons for withdrawal were: parental choice (n
= 6), change in Ritalin dosage (n = 1), and participants
stopped taking Ritalin (n = 2). After attrition during the
first trial, 51 children remained with the study until it
ended (i.e., they completed both trials). Females comprised
14% (n = 7) of the remaining participants. The mean age of
all remaining participants was 8.4 years.
Trial I Hypotheses
The study proposed the following hypotheses for Trial I
in reference to the display of inattentiveness:
1. Participants receiving the dietary supplement
combination were expected to display less inattentiveness
than those receiving the placebo, based on parent and
teacher reports.


7
2. Participants receiving Ritalin plus the dietary
supplement combination were expected to display less
inattentiveness than those receiving Ritalin plus the
placebo, based on parent and teacher reports.
The study proposed the following hypotheses for Trial I
in reference to the display of hyperactivity-impulsivity:
3. Participants receiving the dietary supplement
combination were expected to display less hyperactivity-
impulsivity than those receiving the placebo, based on
parent and teacher reports.
4. Participants receiving Ritalin plus the dietary
supplement combination were expected to display less
hyperactivity-impulsivity than those receiving Ritalin plus
the placebo, based on parent and teacher reports.
Trial II Hypotheses
The study proposed the following hypotheses for Trial
II in reference to the display of inattentiveness:
1. Participants receiving the double dietary supplement
combination with an essential fatty acid were expected to
display less inattentiveness than those receiving the double
dietary supplement combination, based on parent and teacher
reports.


8
2. Participants receiving Ritalin plus the double
dietary supplement combination with an essential fatty acid
were expected to display less inattentiveness than those
receiving Ritalin plus the double dietary supplement
combination, based on parent and teacher reports.
The study proposed the following hypotheses for Trial
II in reference to the display of hyperactivity-impulsivity:
3. Participants receiving the double dietary supplement
combination with an essential fatty acid were expected to
display less hyperactivity-impulsivity than those receiving
the double dietary supplement combination, based on parent
and teacher reports.
4. Participants receiving Ritalin plus the double
dietary supplement combination with an essential fatty acid
were expected to display less hyperactivity-impulsivity than
those receiving Ritalin plus the double dietary supplement
combination, based on parent and teacher reports.
Overview
A review of relevant research and related literature on
ADHD is presented in Chapter Two. A detailed description of
the study's methodology is included in Chapter Three.
Results of this study are presented in Chapter Four. A
discussion of the results, study limitations, and


9
recommendations for future research are included in Chapter
Five.


CHAPTER TWO
REVIEW OF LITERATURE
Historical Views
The roots of ADHD can be traced back thousands of
years. The ancient Greeks described the disorder's common
features (i.e., inattentiveness and hyperactivity) (Husain &
Cantwell, 1991) German physician Heinrich Hoffman described
these ADHD characteristics in 1845 (Cantwell, 1975). Our
present concept of ADHD has its foundation in the work of
George Frederic Still and Alfred Tredgold (Sandberg &
Barton, 1996).
Still (1902) described an ADHD-type cluster of
behaviors that included hyperactivity, inattention, and
conduct disturbance in children. He attributed hyperactive
behavior to a defect of moral control. This theory is
supported by the proposal that suggests ADHD is a deficit in
sensitivity to reinforcement (Haenlein & Caul, 1987) or
rule-governed behavior (Barkley, 1981, 1989b). A theory of
deficient attention, inhibition, and arousal, and preference
for immediate reward also provides evidence for this claim
10


11
(Douglas, 1972, 1983). Still's research parallels many of
the facets of our current knowledge of ADHD, namely a
heredity component of the disorder, and the possibility that
ADHD occurs from acquired nervous system injury (Barkley,
1997a).
Extreme defects observed in Still's sample of children
were due more to biological factors than environmental
factors. ADHD was thought to be caused by genetic
transmission, central nervous system damage, or certain
brain diseases or infection (Mellor, Storer, & Brown, 1996).
Tredgold (1908) adopted the theory that damage, often mild
and undetected, occurred in the early stages of an
individual's development. Damage resulted in behavioral
problems or hyperactivity. This belief gained support
following the 1917-18 encephalitis epidemic when children
began suffering from both behavioral and cognitive problems
(Sandberg & Barton, 1996).
Theoretical Views
Several theories to explain ADHD have been postulated.
One theory suggests a central deficiency in inhibitory
processes is present in persons with ADHD (Schachar & Logan,
1990). This theory proposes that an event or stimulus is
hypothesized to trigger an activating or primary response


12
and an inhibitory response. As a result, there is
competition between the two with reference to which will be
executed first. Disinhibited children (e.g., those with
ADHD) have a slower start of inhibitory processes compared
to normal children (Schachar, Tannock, & Logan, 1993).
Another theory conceptualizes persons with attention
deficits as hunters in a farmer's world (Hartmann, 1997).
That is, those with the disorder are "hunters," while those
without it are "farmers." Individuals with attention
deficits are considered leftover hunters whose ancestors
evolved and matured thousands of years ago in hunting
societies. Their characteristics (i.e., impulsivity,
distraction, and even aggression) make them ideal for
hunting. However, the criteria for this theory may have been
developed from observations of individuals with ADHD rather
than hunters, since some hunters never display the clinical
symptoms of ADHD (Shelley-Tremblay & Rosen, 1996).
A recent theory centers around the assumption that the
impairment in ADHD is a deficit in response inhibition
(Barkley, 1997b). Developmental failure in the circuitry
underlying inhibition and self-control is believed to be the
cause of ADHD (Barkley, 1998). The theory's model postulates
a link between response inhibition and four executive


13
neuropsychological functions: working memory, self-
regulation of affect-motivation-arousal, internalization of
speech, and reconstitution (behavior analysis and
synthesis), which depend on this inhibition for effective
performance. Evidence suggests deficits in behavioral
inhibition, working memory, and regulation of motivation are
most prominent in persons with ADHD.
Characteristics
ADHD is a treatable but not curable complex disorder.
Children and adolescents comprise the ages most
predominantly affected. The disorder typically occurs in
children between ages 3 and 7 (Loeber, Green, Lahey, Christ,
& Frick, 1992), and is diagnosed using criteria established
in the DSM-IV (American Psychiatric Association, 1994).
The incidence of ADHD-related behaviors, while low in
preschool and kindergarten, increases dramatically in first
grade and remains fairly stable thereafter (Pellegrini &
Horvat, 1995). Symptoms diminish by approximately 50% every
five years between the ages of 10 and 25 (Goldman et al.,
1998). Up to 50% of children with ADHD display significant
symptoms at age 25 (Mannuzza, Klein, Bonagura, Malloy,
Giampino, & Addalli, 1991; Weiss, Milroy, & Perlman, 1985),
and some believe the syndrome never disappears with maturity


14
(Gittelman, Mannuzza, Shenker, & Bonagura, 1985; Gross,
1997; Hechtman, 1992; Klein & Mannuzza, 1991; Weiss et al.,
1985). ADHD usually is characterized by serious and
persistent difficulties resulting in inattention,
hyperactivity, and impulsivity (American Psychiatric
Association, 1994).
Inattention
Inattention comprises a main characteristic of children
with ADHD. Teachers often note these children do not listen
as well as they should, cannot concentrate, daydream, and
change activities more than others. Inattention is a multi
dimensional construct referring to problems with alertness,
arousal, selectivity, sustained attention, and
distractibility (Hale & Lewis, 1979). Inattention is seen
most often in activities requiring children to sustain
attention to dull, boring, repetitive tasks (e.g.,
schoolwork, homework, chores) (Luk, 1985; Milich, Loney, &
Landau, 1982; Ullman, Barkley, & Brown, 1978). Inattention
also is seen in children who are more disorganized,
forgetful, and distracted than their peers.
Hyperactivity
Hyperactivity typically is the most visible and
observable characteristic of children with ADHD. Hyperactive


15
children often fidget, are noisy, and engage in nervous
habits (e.g., finger tapping, hair twirling). They become
easily over-excited and loud when externally over-
stimulated. They frequently change activities without fully
completing them. Many children exhibit hyperactive symptoms,
but it is the frequency, duration, and intensity with which
they occur that determine a diagnosis of ADHD.
Impulsivity
Children with ADHD act impulsively, showing little
regard for the consequences of their actions. Students
encounter trouble because they make decisions and act too
quickly without allowing sufficient time between
presentation of the stimulus and their response (Lerner,
Lowenthal, & Lerner, 1995). Displays of impulsivity in
school--shouting out remarks without waiting for their turn,
answering questions before hearing or reading the entire
problem, or interrupting otherscan lead to deficient
academic attainment and inadequate social relationships.
Prevalence
ADHD is the most common chronic behavioral disorder in
children (Johnson, 1997). It is not limited to one
particular group. Children who are gifted and talented also


16
may exhibit symptoms of ADHD. The disorder also occurs
across cultures and ethnic groups.
The prevalence of ADHD, the proportion of the
population affected, is estimated between 6 and 8% of
school-aged children (Baren, 1995) Depending on the
criteria used for diagnosis, the prevalence rate may be as
high as 10% (Tan & Schneider, 1997). Disagreement about the
prevalence of ADHD is due, in part, to lack of agreement
among professionals as to which neurological dysfunctions
characterize the syndrome (Gross, 1997).
The disorder is more common in boys. The male-female
ratio ranges from 2:1 to 10:1 (Szatmari, Offord, & Boyle,
1989). The greater frequency with which it occurs in males
may be attributed to the fact that boys are far more likely
than girls to be referred for evaluation, especially if they
display oppositional or conduct disorders (Barkley, 1996;
Swanson, Sergeant, Taylor, Sonuga-Barke, Jensen, & Cantwell,
1998). Although boys evidence more neuropsychological
disorders, gender differences and neuropsychological
performance of children with ADHD remain largely unexamined
(Arcia & Conners, 1998).


17
Girls with ADHD may be more likely to go undetected
(Berry, Shaywitz, & Shaywitz, 1985; Hinshaw, 1994; Szatmari
et al. 1989) Since girls are less aggressive, they are
more likely to mask symptoms of ADHD (Bain, 1991; Buncher,
1996). More females are likely to be diagnosed as
"predominantly inattentive" following the publication of the
DSM-IV (Boliek & Obrzut, 1997) .
Incidence
ADHD affects approximately 2 to 3 million school-aged
children in the United States (Ricchini, 1997). Every
classroom from kindergarten through 12th grade in the U.S.
on average has one of two students who has been diagnosed
with the disorder (Schneider & Tan, 1997). While some claim
ADHD is over-diagnosed, research suggests this may not be
the case (Goldman et al., 1998). Researchers found that
although some children are being diagnosed with ADHD without
a sufficient evaluation, there is little evidence of
widespread over-diagnosis of the disorder.
The number of children identified with ADHD recently
has increased dramatically. It is difficult to determine
whether the increase in the prevalence of ADHD is the result
of clearer clinical diagnosis or better recognition of the
disorder over the past four decades (Scahill & deGraft-


18
Johnson, 1997). Increases also may be attributed to
different methods for selecting subjects for research
studies (Barkley, 1996), the key symptoms emphasized
(Sherman, McGue, & Iacono, 1997), who reports the occurrence
of behaviors (Sherman et al., 1997), and age ranges of
samples (Barkley, 1996).
Etiology
The study of the causes of hyperactivity has occurred
in distinct periods (Williams & Cram, 1978). Before World
War II, hyperactive behaviors were believed to be related to
brain damage. From World War II to 1960, attention was
placed on the symptomatology of minimal brain dysfunction.
Severely overactive and disruptive children were believed to
have a central nervous system deficit in the thalamic area
of their brain, resulting in cortical overstimulation. Since
1960, deficits in sustained attention and impulse control
have been considered more likely to account for
hyperactivity.
The etiology of ADHD remains unclear. Precipitating
factors often are unknown and the cause typically is
considered idiopathic (Boris & Mande1, 1994). Symptoms of
ADHD may result from a variety of causal mechanisms, such as
pre- and postnatal factors, neurological variables,


19
neurochemicals, genetics, diet, candidiasis, temperament,
and lead exposure.
Pre- and Post-natal Factors
Prenatal factors can put a fetus at risk. Absence of
prenatal care, inadequate maternal nutrition, infections,
stress, and metabolic or toxic factors may impact a
developing fetus. Anepartum hemorrhage and length of labor
have been associated with ADHD (Chandola, Robling, Peters,
Melville-Thomas, & McGuffin, 1992). Prenatal exposure to
alcohol and tobacco smoke is related to inattention and
hyperactivity (Bennett, Wolin, & Reiss, 1988; Milberger,
Biederman, Faraone, & Jones, 1998; Nichols & Chen, 1981;
Shaywitz, Cohen, & Shaywitz, 1980; Streissguth, Martin,
Barr, Sandman, Kirchner, & Darby, 1984), and children born
with fetal alcohol syndrome were found to exhibit symptoms
of hyperactivity, impulsivity, and inattention (Frederick,
1998).
Acquired medical problems and extensive post-natal
trauma to the nervous system can result in ADHD or ADHD-like
behaviors (Silver, 1992). An association between otitis
media in infancy and later development of ADHD has been
discovered (Adesman, Altshuler, Lipkin, & Walco, 1990;
Weintraub, 1997). Effects of viral encephalitis can include


20
hyperactivity, distractibility, and impulsivity (Tredgold,
1908). Children and adolescents with a history of a closed
head injury also may display these behaviors.
Neurological Variables
A neurological basis of ADHD has been suggested
(Rosenberger, 1991) The early onset and persistent nature
of ADHD support this neurological origin. The belief that
dysfunction in the brain or central nervous system causes
ADHD has been held for almost a century (Lerner et al.,
1995). Frontal lobe underactivity is associated with ADHD
(Chelune, Ferguson, & Richard, 1986; Lou, Henriksen, &
Bruhn, 1984). Findings of deficient performance on
neuropsychological tests associated with prefrontal lobe
functions (e.g., inhibition, persistence, working memory)
further support a neurological basis (Barkley, 1990;
Barkley, Grodzinsky, & DuPaul, 1992; Goodyear & Hynd, 1992).
Brain damage
The purpose of the brain is to control movement, sleep,
hunger, thirst, and nearly every other vital activity
necessary for survival. It also receives and interprets
countless signals sent to it from other parts of the body
and from the external environment. Thus, proper functioning
of the brain is critical.


21
The first neurological theory hypothesized children
with ADHD had structural brain damage that contributed to
their attention and behavior difficulties (Anastopoulos &
Barkley, 1988) Current evidence suggests most children with
ADHD do not have structural defects in the central nervous
system. Thus, structural brain damage is no longer
considered a primary cause of ADHD (Barkley, 1990) .
Reticular activating system
The lower portion of the brain contains the Reticular
Activating System (RAS), the attention center in the brain.
The purpose of the RAS is to regulate the level of alertness
and arousal and filter out irrelevant distractors in the
environment. When functioning properly, the RAS provides the
neural connections needed to attend to a task. If the RAS
does not excite the neurons of the cortex as much as it
should, underarousal results in a lack of self-control, poor
memory, and learning difficulties. An excited RAS leads to
an overarousal of the cortex and other brain systems. This
can cause an individual to talk too much, become restless,
and act hyperactive. A dysfunction in the RAS has been
proposed as a neurological basis for ADHD (Nussbaum &
Bigler, 1990).


22
Neurochemicals
The purpose of neurotransmitters is to facilitate
communication among cells. An imbalance or deficiency in
certain neurotransmitters has been studied as an etiological
variable (Raskin, Shaywitz, Shaywitz, Anderson, & Cohen,
1981). Children with ADHD are believed to possess an
insufficient amount of necessary chemicals in their brains
(Friedman & Doyal, 1992; Goldstein & Goldstein, 1990).
Studies of monoamines have received the most attention as a
possible cause of ADHD (Kado & Takagi, 1996; Silver, 1992).
Monoamines are comprised of the catecholamines (e.g.,
dopamine and norepinephrine) and the indoleamines (e.g.,
serotonin). Metabolic studies have shown that glucose
(Zametkin, Nordahl, Gross, King, Semple, Rumsey, Hamburger,
& Cohen, 1990), norepinephrine (Shekim, Javaid, Davis, &
Bylund, 1983; Shekim, Javaid, Dekirmenjian, Chapel, & Davis,
1982), dopamine (Shaywitz, Yager, & Klopper, 1976),
adrenaline (Weintraub, 1997), and thyroid dysfunction
(Hauser, Zametkin, Martinez, Vitiello, Matochik, Mixson, &
Weintraub, 1993) are related to ADHD.
Dopamine and norepinephrine are the two most important
chemicals in the attentional system (Goldstein & Goldstein,
1990). These neurotransmitters affect the regulation of


23
attention, inhibition, and motor responses. They are
presumed to be deficient in certain regions of the brain,
thus contributing to symptoms of ADHD (DuPaul & Stoner,
1994).
Research on cerebral glucose metabolism has provided
strong evidence of a biological basis for ADHD (Zametkin et
al., 1990). Glucose promotes human cell development. Rates
of metabolism are significantly slower in those with ADHD.
Researchers also discovered a relationship between the areas
of the brain affected and the nature of the symptoms of
hyperactivity in adults.
Genetic Influence
Some have postulated a genetic contribution to ADHD
(Cantwell, 1972; Hechtman, 1993; Fouse & Brians, 1993;
Rutter, Macdonald, LeCoutier, Harrington, Bolton, & Bailey,
1990; Sherman, Iacono, & McGue, 1997; Stevenson, 1992). The
discovery of an association with a single dopamine
transporter gene (Cook, Stein, Krasowski, Cox, Olkon,
Kieffer, & Leventhal, 1995) and a variation in the D4
dopamine receptor gene (LaHoste, Swanson, Wigal, Glabe,
Wigal, King, & Kennedy, 1996; Swanson, Sunohara, Kennedy,
Regino, Fineberg, Wigal, Lerner, Williams, LaHoste, & Wigal,
1998) has increased the interest in a genetic basis. Genetic


24
studies may provide evidence for an underlying genetic
relationships between clinical phenotypes, thus leading to
biologically based understanding of the diagnosis and
treatment of ADHD (Levy, Barr, & Sunohara, 1998).
Family studies
Results of behavioral genetic studies have provided
additional evidence supporting a hereditary contribution
(DuPaul & Stoner, 1994; Faraone, Biederman, Keenan, &
Tsuang, 1991; Gross-Tsur, Shalev, & Amir, 1991). Immediate
family members of children with ADHD have a higher rate of
concurrent and past ADHD symptoms than their non-ADHD
counterparts (Anastopoulos & Barkley, 1988). Up to 20% of
mothers (Silver, 1992), up to 30% of fathers (Silver, 1992),
and up to 35% of biological siblings (Biederman, Faraone, et
al., 1991; Biederman, Faraone, & Lapey, 1992; Pauls, 1991;
Silver, 1992; Weiner, Weiner, Stewart, Palkes, & Wish, 1977)
of children with ADHD have the disorder. Second-degree
relatives also display a higher incidence of ADHD (Faraone,
Biederman, & Milberger, 1994). However, it often is
difficult to accurately identify the contributing effects of
genetics and environment, inasmuch as the two co-occur.


25
Twin studies
Monozygotic twins display higher rates of ADHD when
compared to dizygotic twins (Cunningham & Barkley, 1978;
Heffron, Martin, & Welsh, 1984; Lopez, 1965; Sherman, McGue,
et al., 1997). There is a high concordance for hyperactivity
and inattention in monozygotic pairs (51 to 100%) and
dizygotic pairs (17 to 33%) (Gillis, Gilger, Pennington, &
DeFries, 1992; Goodman & Stevenson, 1989; O'Connor, Foch,
Sherry, & Plomin, 1980; Willerman, 1973) .
Adoption studies
The adoption study method is regarded as one of the
most powerful tools for studying complex human behavioral
disorders (DeFries & Plomin, 1978). Studies of adopted
children with hyperactivity report higher rates of
hyperactivity in the biological parents than in the adoptive
parents (Alberts-Corush, Firestone, & Goodman, 1986;
Cantwell, 1975; Morrison & Stewart, 1971, 1973). A strong
genetic component also has been shown for attention problems
among biologically-related adoptees (van den Oord, Boomsma,
& Verhulst, 1994).
Diet Factors
The role of diet in behavior has been investigated for
many years. Early research suggested that behavior and


26
learning can be affected by diet (Shannon, 1922). In a
majority of studies, a significant change in behavior was
noted with dietary intervention (Breakey, 1997). Certain
foods have been shown to alter brain electrical activity
(Uhlig, Merkenschlager, Brandmaier, & Egger, 1997), and
children on an elimination diet exhibited normalization in
previous EEG abnormalities (Kittler & Baldwin, 1970). In
addition, food allergies and sensitivities and food
additives have been cited as affecting behavior.
Food allergies
Reports since the 1920s have linked hyperactive
behavior with food allergies (Crook, 1997; Ross & Ross,
1976). Food allergies may be related to the onset or
exacerbation of ADHD. It has been suggested that two-thirds
of children with ADHD would not need pharmaceutical
intervention if their food allergies were detected and
treated (Rapp, 1998). Symptoms of irritability, fatigue, and
behavior problems have been attributed to an allergic
response to foods (Randolph, 1947).
Food allergies may have a cumulative effect, causing a
child with a weak sensitivity to certain foods to become
hyperactive if a large amount of these foods are consumed
within a short period of time (Conners, 1980b). The


27
relationship between food allergies and hyperactivity is
strongest in hyperactive children who also exhibit evidence
of learning disabilities and minimal brain dysfunction
concurrently (Trites, Tryphonas, & Ferguson, 1980). However,
empirical data do not support the claim that food allergies
play a role in ADHD (Palmer, Rapoport, & Quinn, 1975; Trites
et al., 1980; Tryphonas & Trites, 1979; Varley, 1984).
Food sensitivities
Response to food dyes and additives is considered a
sensitivity, not an allergy, since the primary symptoms are
behavioral disturbances (e.g., short attention span,
nervousness) rather than physical disturbances (e.g., hives,
respiratory problems (Swanson & Kinsbourne, 1980a).
Sensitivities to food dyes have been reported since 1940
(Weintraub, 1997). Clinical cases of hypersensitivity are
noted with dyes commonly ingested from foods and medicines
(Lockey, 1971, 1977). This sensitivity may lead to an
intolerance of different foods, resulting in hyperactivity,
aggression, mood swings, and rebellion (Jordan, 1998).
Food dyes, additives, and natural salicylates are
implicated as a cause of ADHD (Feingold, 1973a, 1975a,
1975b). A relationship was first noted when a patient's
hostile and aggressive behavior ceased following a diet that


28
excluded artificial colors and flavors (Harley & Matthews,
1980). Sensitivity to artificial colors is caused by a
pharmacological response, similar to a sensitivity to
aspirin (Feingold, 1975a, 1975b).
Thirty-four synthetic food colors, 1,610 synthetic
flavors, and 1,120 other chemicals (e.g., preservatives)
added to foods are believed to cause hyperactivity once
ingested (Feingold, 1973b). Natural salicylates also have
been targeted in the belief that they cross-react with
additives (Swanson & Kinsbourne, 1980a). The increased
incidence of hyperactivity is related to an increase in
consumption of food colorings, flavorings, and preservatives
(Feingold, 1975a, 1975b). Removal of the substances
reportedly terminates the hyperactive symptoms.
Evidence suggests that children affected by food dyes
and additives differ biochemically from those who remain
unaffected (Brenner, 1979). Some researchers believe
children are born with a genetic predisposition for
hyperactivity that is triggered by these substances. For
example, Erythrosin B (i.e., Red No. 3) often is used in
candies, powdered desserts, and beverages. Concentrations of
this dye partially prevents brain cells from taking in
dopamine (Augustine & Levitan, 1980; Lafferman & Silbergeld,


29
1979). The blocking of dopamine by the food dye is
consistent with the theory that the dye can cause
hyperactivity in some children.
Candidiasis
Symptoms of ADHD have been attributed to Candida
albicans, a common yeast in the human body (Bell & Peiper,
1997; Crook, 1983, 1997). Candidiasis, an overgrowth of this
yeast, causes a release of toxins in the intestines that
results in hyperactivity, irritability, anxiety, and other
symptoms (Rapp, 1991). Yeast interferes with the formation
of fatty acid conversions and can overwhelm and damage the
immune system, especially when using antibiotics.
Antibiotics increase the growth of yeast, which in turn
increase the absorption of food antigens, putting a child at
risk for food sensitivities. This may play an important role
in causing ADHD and other behavior and learning problems
(Weintraub, 1997).
Temperament
Children's temperament may contribute to their ADHD
symptoms (Friedman & Doyal, 1992). Studies of temperament in
hyperactive children indicate its importance in the
development of hyperactivity (Prior & Griffin, 1985).
Temperament patterns differ for hyperactive and control


30
subjects (Dudding & Dudding, 1995; Lambert, 1982). Children
with hyperactivity are characterized by low adaptability,
low persistence, high activity, and high negativism (Carey &
McDevitt, 1980). An effort must be made to determine whether
hyperactivity is a reflection of ADHD, an expression of
temperament characteristics, or a combination of the two
(Friedman & Doyal, 1992).
Temperament was only one of three factors to contribute
to hyperactivity (i.e., pre- and peri-natal factors, family,
and home environmental characteristics). Its contribution
has been found to be more significant than the others
(Lambert, 1982; Lambert & Hartsough, 1984). Differences in
temperament between hyperactive and non-hyperactive children
of the same age, gender, and social class are noted for
children as young as preschoolers (Prior, Leonard, & Wood,
1983).
The diagnosis of ADHD among school children may be
attributed to personality type (Provost, 1994), and its
diagnosis may be related to an insufficient appreciation of
normal temperament variations (Carey, 1998). Type
preferences of teachers and parents predisposes them to
conflict with children who manifest ADHD symptoms (Johnson,
1995). For example, introverted parents or teachers may view


31
children with an extroverted personality as more likely to
possess the disorder.
Lead Exposure
Exposure to lead is one the nation's most serious
environmental threat to children's health. Factory exhaust,
urban topsoil, water pipes, metal food containers, fruits
and vegetables, and paint may contain high levels of lead.
Many of the children affected are from economically-
impoverished families. In the United States, half a million
children on Medicaid ages five years and under have harmful
levels of lead in their blood ("Lead Screening," 1998).
The neurotoxic effects of lead affects brain function
and is associated with a number of neurological and
psychological disorders, including ADHD (Baloh, Sturm,
Green, & Gleser, 1975; David, 1974; de la Burde & Choate,
1972, 1974; Walker, 1996; Weintraub, 1997). Exposure to lead
is linked to disruptive behavior, distractibility,
impulsivity, poor school performance, and low IQ (Fergusson
& Horwood, 1993; Fergusson, Horwood, & Lynskey, 1993;
Needleman, Schell, Bellinger, Levitn, & Allrich, 1990;
Thomson, Raab, Hepburn, Hunter, Fulton, & Laxen, 1989; Yule,
Lansdown, Millar, & Urbanowicz, 1981). Lead poisoning also
has been shown to be associated with ADHD (David, Clark, &


32
Voeller, 1972; Rummo, Routh, Rummo, & Brown, 1979).
Treatment to reduce the levels of body lead has accounted
for behavioral improvements in hyperactive children (David,
Hoffman, Sverd, Clark, & Voeller, 1976; Eppright, Sanfacon,
& Horwitz, 1996).
Diagnosis
A diagnosis of ADHD requires a comprehensive and
detailed evaluation. Diagnosing hyperactivity and
impulsivity remains subjective, despite sophisticated
assessment techniques (Johnson, 1997). A diagnosis comes
from a number of sources, based on an evaluation of the
intensity and duration of symptoms (Buncher, 1996). An
appropriate assessment includes a medical, behavioral, and
educational history, evidence of normal vision and hearing,
recognition of systemic illness, and a developmental survey
(National Attention Deficit Disorder Association, 1998).
ADHD is diagnosed exclusively on the basis of observable
behavior patterns, since it is difficult to determine
specific biochemical or neuropsychological tests that
contribute to a more accurate diagnosis (Kuperman, Johnson,
Arndt, Lindgren, & Wolraich, 1996). The delineation from
normals is partially determined by local cultural factors


33
since no biological markers for general use exist (Lou,
1996).
Specifying symptoms to ADHD has not been demonstrated
(Halperin, Matier, Bedi, Sharma, & Newcorn, 1992).
Confounding diagnosis is the problem of other conditions
sharing similar symptoms (Buncher, 1996). These include
processing disorders (e.g., language disorders), medical
disorders (e.g., hyperthyroidism, infections, seizure
disorders), chromosomal or genetic abnormalities (e.g.,
Turner's syndrome, Tourette's syndrome, sickle-cell anemia),
emotional disorders (e.g., depression, anxiety, manic-
depression), and environmental factors (e.g., dysfunctional
family dynamics, abusive home situations, school placement).
Studies attempting to distinguish children with ADHD from
other patient groups, based on measures of attention, have
yielded negative results (Koriath, Gualtieri, Van
Bourgondien, Quade, & Werry, 1985; Shapiro & Garfinkel,
1986; Werry, Elkind, & Reeves, 1987). Although behaviors
from these disorders may be similar to ADHD, their causes
and treatments are different.
DSM-IV Criteria
The main feature of ADHD, as outlined in the DSM-IV, is
a persistent pattern of inattention or hyperactivity-


34
impulsivity that occurs more frequently and severely than in
a child's same-age peers. The symptom pattern must have
appeared before age 7 years and the impairment must be
observed in at least two settings (e.g., school and home).
Children with ADHD differ from their peers only in the
intensity, persistence, and clustering of symptoms (Lin-
Dyken & Wolraich, 1992).
The diagnostic criteria of ADHD are empirically-based.
They were derived from leading experts, literature reviews,
an informal survey of rating scales assessing the behavioral
dimensions related to ADHD, and statistical analyses from a
field trial of items (Barkley, 1996). The DSM-IV outlines
distinct subtypes of ADHD to help aid in the diagnosis of
the disorder. These subtypes are: predominantly inattentive
type, predominantly hyperactive-impulsive type, and combined
type.
Predominantly inattentive type (ADHD-PI)
Specific symptoms of inattention, hyperactivity, or
impulsivity must be displayed in academic, social, or
occupational situations. In their schoolwork, children with
ADHD may demonstrate characteristics of inattention by not
paying attention to details and making careless mistakes.
They find it difficult to persist with tasks, act as if they


35
are not listening, shift from one uncompleted task to the
next, and fail to complete their assignments, even if
instructions were understood (Boliek & Obrzut, 1997) .
Homework assignments are avoided because they require
sustained attention and organization. Six of nine
inattention characteristics from the DSM-IV must be present
and considered deviant.
Predominantly hyperactive-impulsive type (ADHD-PHI)
Children who are hyperactive can be viewed as having
excessive amounts of locomotion, such as excessive movement
in their seat, running or climbing at inappropriate times,
talking indiscriminately, or poor control of motor system.
Toddlers and preschoolers display the same behaviors,
although less frequent and less intense. Adolescents and
adults may feel restless and find it difficult to
participate in sedentary activities.
Children described as impulsive lack patience and find
it difficult to delay responses to their external
environment. They may make comments out of turn or at
inappropriate times. Children with ADHD often interrupt
others, do not wait for instructions or directions, and
touch objects off-limits. Six of nine hyperactivity-
impulsivity characteristics from the DSM-IV must be present


36
and considered deviant. It is unclear whether children in
the ADHD-PHI category are separate from the ADHD-C (i.e.,
combined type) category or in an earlier developmental stage
of it (Barkley, 1996).
Combined type (ADHD-C)
The combined type is used if six or more symptoms of
hyperactivity-impulsivity, but fewer than six symptoms of
inattention, have persisted for the previous six-month
period. Children may have one subtype of the disorder at one
period of time and may develop another predominant subtype
at a later date. If specific criteria are no longer met for
the three subtypes, the diagnosis made is attention-
deficit/hyperactivity disorder, in partial remission.
Increased Diagnosis
Two federal government programs have been identified as
possibly increasing the diagnosis of ADHD (Merline, 1997).
In 1990, the federal Supplemental Security Income program
was created to provide money, as much as $560 per month for
each child, to low-income parents of children diagnosed with
ADHD. Special education grant money became available in
1991, with $400 in grant money being awarded to schools for
each student diagnosed with the disorder. The diagnosis of
ADHD was level prior to the inception of these two programs


37
but has increased 21% each year since (Merline, 1997). Other
factors also that may contribute to an increase in a
diagnosis include: increased public and physician awareness
and acceptance of the condition, acceptance of a broader
case definition, greater knowledge of the illness course,
fewer interruptions in treatment because of diminished
concerns regarding growth retardation, and increased
treatment of adults (Goldman et al., 1998).
Misdiagnosis
Misdiagnosis of ADHD is a potential problem. In one
study, about half of the children at one military hospital
did not meet the standards in the DSM-IV, although all were
being given medication for their symptoms (Debroitner &
Hart, 1997). Misdiagnosis may occur because the symptoms of
ADHD are shared with other disorders. Therefore, it is
important that a comprehensive medical evaluation be
conducted before treatment begins.
Assessment
School-based evaluation of ADHD is conducted in five
stages (Figure 1) (DuPaul & Stoner, 1994). The stages are
based upon an educational decision-making model. These five
stages include: screening, multimethod assessment,


38
Teacher Complaint of Inattention,
Impulsivity, and/or Overactivity
Stage 1: Screening
Teacher Ratings of ADHD Symptoms
1
Stage 2: Multimethod Assessment of ADHD
Parent and Teacher Interviews
Reviews of School Records
Behavior Rating Scales
Observations of School Behavior
Academic Performance Data
1
Stage 3: Interpretation of Results
Number of ADHD Symptoms
Deviance from Age and Gender Norms
Age of Onset and Chronicity
Pervasiveness Across Situations
Degree of Functional Impairment
Rule-out Other Disorders
I
Stage 4: Develop Treatment Plan, Based Upon:
Severity of ADHD Symptoms
Functional Analysis of Behavior
Presence of Associated Disorders
Response to Prior Treatment
Community-based Resources
I
Stage 5: Assessment of Treatment Plan
Periodic Collection of Assessment Data
Revision of Treatment Plan
Figure 1. Five Stages of School-based Assessment of ADHD
(adapted from DuPaul & Stoner, 1994).


39
interpretation of results, development of a treatment plan,
and assessment of the treatment plan.
The first stage includes the determination of whether a
student has problems related to ADHD. If so, a decision is
made in reference to the need for further assessment. A
teacher interview will help to specify the behavioral
concerns and to identify environmental factors that may
contribute to problem behavior. The interview will provide
information on the frequency, intensity, and duration of
these behaviors, and whether environmental factors (e.g.,
method of instruction, transition) act as an antecedent or
consequent event for behavior. Teacher ratings of ADHD
symptoms also are obtained.
Multiple assessment techniques are utilized during the
second stage. Parent and teacher interviews are conducted to
specify behaviors and the factors maintaining them. They
also will complete questionnaires to provide information
regarding the frequency and severity of behaviors. School
records and academic performance data are reviewed to
provide historical and current data. Direct observation of
the child across settings can provide further evidence of
the frequency and duration of target behaviors.


40
Assessment results are interpreted during the third
stage. The goal is to obtain a consistent picture of the
frequency and severity of ADHD behaviors across settings,
including possible causes. A child's behavior is evaluated
using DSM-IV criteria. Both parents and teachers provide
information about the number of symptoms, deviance from age
and gender norms, age and onset of chronicity, pervasiveness
across situations, and degree of functional impairment.
Other causes (e.g., poor or inconsistent instruction or
behavior management) are ruled out before a diagnostic
decision is reached.
A treatment plan is developed during the fourth stage.
Interventions are designed to target behaviors across
academic and social domains. The severity of a child's
symptoms must be considered, as more severe symptoms
increase the likelihood the child will be referred to a
physician. The presence of additional behavior or learning
disorders must be considered when developing treatment
strategies, and these strategies are contingent upon the
child's response to previous interventions. The availability
of treatment resources must be considered. This will decide
whether the child is referred to a community-based
professional (e.g., child psychologist) or whether home-


41
based interventions designed by the school psychologist are
implemented.
An assessment of treatment is conducted during the
fifth stage. The student acts as his or her own control, and
behavioral change is evaluated in comparison to
nonintervention conditions. Assessment data are repeatedly
acquired across settings at different points in the
intervention program. If reliable behavior change occurs, it
can be assumed that the intervention was successful. If no
change occurs, the intervention, or the way it is
implemented, must be changed. Thus, ongoing assessment is
very important.
Assessment Techniques
Over half of all children with ADHD are diagnosed in
their elementary school years (Quinn, 1997). Consequently,
with the exception of parents, teachers often are the first
persons to observe the characteristics of ADHD. Children
with ADHD are more inattentive, overactive, and impulsive
than normal children. Measures of these constructs include
observational procedures (Abikoff, Gittelman-Klein, & Klein,
1977; Atkins, Pelham, & Licht, 1985; Milich et al., 1982),
behavior rating scales (Conners, 1969; McGee, Williams, &
Silva, 1984), psychometric tests (Campbell, Douglas, &


42
Morgenstern, 1971), and continuous performance tests (Klee &
Garfinkel, 1983; Sykes, Douglas, Weiss, & Minde, 1971).
Observational procedures
A behavioral observation assessment approach typically
is used to evaluate ADHD. Multiple methods of data
collection are employed with different observers across
different settings (DuPaul & Stoner, 1994). Emphasis is
placed on obtaining reliable information about a child's
behavior from parents and teachers. The evaluation should
include interviews with the child's parents and teachers,
questionnaires completed by parents and teachers, and
observations on the child's behavior in different settings.
Behavior rating scales
Behavior rating scales completed by parents and
teachers provide important details about the severity of a
child's symptoms. From this information we are able to
determine the degree to which a child's characteristics are
also exhibited by his or her peers. Rating scales collapse
information across situations and time, thus providing
information from persons who live and work with a particular
child (Landau & Burcham, 1995).
Caution must be used since behavior rating scales may
measure teacher and parent tolerance or intolerance of


43
children instead of the child's disability (Patterson,
1996). They also represent only opinions others have of the
child rather than the child's strengths and uniqueness
Landau & Burcham, 1995). However, a diagnosis of ADHD should
never be made based solely on rating scales (National
Attention Deficit Disorder Association, 1998). Examples of
behavior rating scales include: ADD-H: Comprehensive Teacher
Rating Scale (Ullman, Sleator, & Sprague, 1991), ADHD Rating
Scale (DuPaul, 1991), Attention-Deficit/Hyperactivity
Disorder Test (Gilliam, 1995), Attention Deficit Disorders
Evaluation Scale (McCarney, 1995a), Behavioral Assessment
System for Children (Reynolds & Kamphaus, 1992), Child
Behavior Checklist (Achenbach, 1991a), Comprehensive
Behavior Rating Scale for Children (Neeper, Lahey, & Frick,
1990), Conners' Rating Scales-Revised (Conners, 1997a),
Early Childhood Attention Deficit Disorder Evaluation Scales
(McCarney, 1995b), Teacher's Report Form (Achenbach, 1991b),
and Youth Self-Report (Achenbach, 1991c). Rating scales used
to assess comorbid symptoms and disorders include: Beck
Depression Inventory-II (Beck, Steer, & Brown, 1996),
Children's Depression Inventory (Kovacs, 1980/81), Revised
Behavior Problem Checklist (Quay & Peterson, 1987), and
Social Skills Rating System (Gresham & Elliott, 1990).


44
Psychometric tests
Results from cognitive, neuropsychological, and
educational tests usually are not helpful in assessing a
child for ADHD (DuPaul & Stoner, 1994). No individually
administered test or group of tests has an acceptable level
of validity (Barkley, 1991). Children often display
appropriate behavior and attention when task conditions are
highly structured and include one-on-one interaction,
typically found with these testing situations (Barkley,
1990).
Continuous performance test
Standard measures of sustained attention and impulse
control often are included in an evaluation. Frequently used
standardized measures include the Conners' Continuous
Performance Test (Conners, 1994), Gordon Diagnostic System
(Gordon, 1986a), and Test of Variables of Attention
(Greenberg, 1993). They provide data that are less
influenced by factors that may bias parent and teacher
reports (Barkley, 1987; Gordon, 1986b).
Problems Associated with ADHD Symptoms
Taken as a group of symptoms, ADHD may lead to complex
or secondary difficulties (Green & Chee, 1994). A child
often becomes the center of family and classroom problems.


45
These problems include insatiability (e.g., nags and never
lets a matter drop), social clumsiness (e.g., misreads
social cues), poor coordination (e.g., poor flow of
movement), disorganization (e.g., blind to mess), and
variability (e.g., mood swings).
Symptoms of ADHD can have a profound effect on a child.
They often lead to disturbed peer relationships (King &
Young, 1982; Pelham & Bender, 1982; Scahill & deGraft-
Johnson, 1997), negative interactions with teachers (Whalen,
Henker, & Dotemoto, 1980), and low self-esteem (Mellor et
al., 1996; Ricchini, 1997; Safer & Allen, 1976; Weiss,
Hechtman, & Perlman, 1978). Children with ADHD display these
social difficulties very soon after entering the primary
grades (Pellegrini & Horvat, 1995).
As many as 65% of children with ADHD have at least one
comorbid condition (Biederman, Newcorn, & Sprich, 1991).
They have higher than expected rates of conduct disorder
(Loney & Milich, 1982; Szatmari et al., 1989), affective
disorders (Biederman, Faraone, Keenan, Benjamin, Krifcher,
Moore, Sprich-Buckminster, Ugaglia, Jellinek, & Steingard,
1992), and tic disorders (Comings & Comings, 1984; DuPaul, &
Stoner, 1994; Gadow, Nolan, & Sprafkin, 1995; Pauls,
Leckman, & Cohen, 1993).


46
Academic Achievement
Children with ADHD are academic underachievers compared
to their peers (Barkley, 1990; Barkley, DuPaul, & McMurray,
1990; Scahill & deGraft-Johnson, 1997). As many as 80 to 90%
of children with ADHD exhibit some type of underachievement
(Cantwell & Baker, 1991; McEwan, 1998). They demonstrate
significantly lower rates of on-task behavior during work
than that of their classmates (Abikoff et al., 1977). The
cumulative effects of inattention can result in a drop of 7
to 15 IQ points (McEwan, 1998). Additionally, between 30 and
60% of children with ADHD also have learning disabilities or
language problems (Nemethy, 1997), the most common type
being dyslexia (Jordan, 1998). These children are considered
learning disabled because of deficits in the acquisition of
specific academic skills (DuPaul & Stoner, 1994) .
Peer Relationships
It is difficult for children with ADHD to initiate and
maintain friendships with their classmates. Approximately
half may experience trouble making and keeping friends
(McEwan, 1995). They engage in more aggressive interactions
(Pelham & Bender, 1982), disruptions and interference in
group play (Prior & Griffin, 1985), and display more


47
controlling and dominating behaviors with their peers
(Cunningham, Siegel, & Offord, 1985) when compared with
normal children. In general, their peer interactions are
intrusive and often negative (Barkley, 1990).
A high rate of peer rejection exists for children
displaying ADHD-related behaviors (Milich & Landau, 1982;
Pelham & Bender, 1982). For example, they may encounter
trouble playing group sports if they ignore rules, do not
follow instructions, and possess possible visual-motor or
gross motor difficulties. About half of all children with
ADHD have poor motor coordination (Nemethy, 1997). As many
as 60% experience some form of social rejection from their
peers (Guevremont, 1990). Peer rejection is stable over
time, providing evidence of the chronic nature of
interactional difficulties (Parker & Asher, 1987).
Approximately 45% remain rejected one year later, and as
many as 30% maintain their rejected social status for up to
four years (Guevremont, 1990).
Self-esteem
Low self-esteem frequently is reported by children with
ADHD. Self-esteem is particularly at risk at the elementary
school age, and children display low self-esteem as early as
the first or second grade (Campbell, Schleifer, Weiss, &


48
Perlman, 1977). Low self-esteem can occur since children
with ADHD may not perform as well as their peers
academically (Barkley, 1990). In addition, self-esteem of
older children may be damaged when they realize their chance
for entering certain occupations (e.g., military) is reduced
because of prior use of stimulant medications (Johnson,
1998; "Ritalin Use," 1996). However, important short-term
gains from the medication may help to preserve the self
esteem in some children with ADHD, and their parents,
teachers, and peers (Reichenberg-Ullman & Ullman, 1996) .
Conduct Disorder
The presence of ADHD may trigger an early onset of
conduct disorder symptomatology (Hinshaw, Lahey, & Hart,
1993). As many as 50% of children with ADHD will display
enough signs of antisocial behavior to receive a diagnosis
of conduct disorder (Barkley, 1990; Klein & Mannuzza, 1991).
Lying, stealing, and truancy are the behaviors most commonly
occurring with conduct problems. Adolescents with ADHD
engage in activities that result in more school suspensions,
and have more adversarial relationships with police compared
to adolescents without the disorder (Goldstein, 1997). The
overlapping subgroup of children with both conduct disorder
and ADHD display a more destructive form of psychopathology


49
than does either single-diagnosis category (Hinshaw &
Anderson, 1996). They display more physical aggression and a
greater range and greater persistence of antisocial
behavior. Parent and teacher ratings of the symptoms of
conduct disorder correlate highly with each other (Hinshaw,
1987).
Affective Disorders
Disagreement exists with regard to the comorbidity of
affective or mood disorders with ADHD (Hinshaw, 1994). As
many as 20% of children have anxiety or mood disorders
(Goldman et al., 1998). Overlap has been found to occur in
community and clinic samples (Anderson, Williams, McGee, &
Silva, 1987; Biederman, Faraone, et al., 1991). Overlap
rates range from chance levels to over 70% in various
studies (Biederman, Newcorn, et al., 1991). Yet, other
studies have concluded that children with ADHD are not at an
increased risk for mood disorders (Gittelman et al., 1985;
Lahey, Pelham, Schaughency, Atkins, Murphy, Hynd, Russo,
Hartdagen, & Lorys-Vernon, 1988).
Depression
Children diagnosed with ADHD may actually be suffering
from depression (Block, 1996; Bloomfield & McWilliams,
1994). Chronic monopolar depression often is hidden by ADHD


50
(Jordan, 1998). As many as 75% of children with ADHD may
also suffer from depression (Armstrong, 1995).
A familial link between ADHD and depression has been
proposed (Faraone & Biederman, 1998). Adopted children with
ADHD have high rates of depression in their biological
relatives (Deutsch, Swanson, Bruell, Cantwell, Weinberg, &
Baren, 1982). Familial risk analyses suggest major
depression and ADHD may represent a variable expression of
the same etiological factors that cause ADHD (Biederman,
Mick, & Faraone, 1998).
Tic Disorders
Tics are sudden, involuntary, repetitive movements
involving a limited group of muscles. Still's (1902)
research may be the first of its kind to note a comorbid
condition of tics and ADHD. As many as 40 to 60% of children
with tic disorders have a history of ADHD symptomatology
(Comings & Comings, 1987; Goldman et al., 1998; Robertson,
Trimble, & Lees, 1988). Symptoms may worsen once tics begin,
as the child must now face another set of uncontrollable
behaviors.
Pharmacological Intervention
Stimulant medication currently is one of the most
common treatments for ADHD (Epstein et al., 1991). The


51
belief that ADHD has a biological basis is supported by the
positive effects of stimulant medications. Reportedly,
response rate to stimulant medications varies from 70 to 96%
(Elia, Borcherding, Rapoport, & Keysor, 1991). However, a
person's response to medication is not a valid justification
of the presence of ADHD (National Attention Deficit Disorder
Association, 1998).
Many parents support the notion that behaviors
associated with ADHD can be treated with medication (Mellor
et al., 1996). Successful medication use removes the focus
from other etiological factors (e.g., psychosocial factors).
A dysfunctional family relationship is thus eliminated as
the cause of a child's ADHD, since poor parenting often is
an underlying suspicion of many clinicians. Medications also
may have a significant positive effect by reducing stress in
parents (Swanson, McBurnett, Wigal, Pfiffner, Lerner,
Williams, Christian, Tamm, Willcutt, Crowley, Clevenger,
Khouzam, Woo, Crinella, & Fisher, 1993). Its use is
convenient and does not disrupt family schedules.
Stimulant Medications
Stimulant medication was first proposed as a treatment
for hyperactivity in the 1930s (Bradley, 1937) although
pharmacology was not introduced for another two decades


52
(Williams & Cram, 1978). Widespread use of stimulant
medication for children with hyperactivity occurred during
the 1960s. By the 1970s social concerns were raised with
regard to the use of stimulant medication (Weithorn & Ross,
1976). Some suggested hyperactivity was a label physicians
used to extend control over children's behavior through the
use of drugs (Conrad, 1975; Schrog & Divoky, 1975).
According to the Physicians' Desk Reference (1999),
reasons why stimulant medications are effective remain
unclear. Stimulants are believed to be associated with
increased levels of neurotransmitters, such as dopamine and
norepinephrine (Tan & Schneider, 1997). There is greater
activity of neurochemicals in the parts of the brain that
control the ability to attend and remain alert. Recent
evidence in mice studies suggests that Ritalin and other
psychostimulants may decrease hyperactivity by increasing
the levels of serotonin, a neurotransmitter, in the brain
(Gainetdinov, Wetsel, Jones, Levin, Jaber, & Caron, 1999).
Stimulants reduce distractibility, enhance concentration,
and decrease motor restlessness and hyperactivity, although
they do not boost IQ or long-term academic performance
(Merline, 1997). The three most commonly used stimulants are


53
methylphenidate (i.e., Ritalin), dextroamphetamine sulfate
(i.e., Dexedrine), and pemoline (i.e., Cylert).
Worldwide consumption of methylphenidate increased from
3 tons in 1990 to 5 tons in 1995, and was projected to reach
13 tons by 1997 (Ghodse & Kreek, 1998). The United States
produces and consumes five times more methylphenidate than
the rest of the world combined (Drug Enforcement
Administration, 1995). Other countries are beginning to
report an increase in the consumption of the drug as a
treatment for ADHD (Ghodse & Kreek, 1998).
The number of people taking Ritalin doubled between
1993 and 1995, and about three-fourths of the 2.6 million
consumers of Ritalin are ADHD children aged 5 to 12 (Price,
1996). It is prescribed in more than 90% of children with
ADHD who receive stimulant medication (DuPaul & Stoner,
1994; Goldman et al., 1998). The number of American children
taking stimulant medications has doubled every two years
since 1988 and should reach 8 million by the year 2000
(Guistolise, 1998). The United Nations is concerned about
Ritalin "being passed out as freely as candy in the United
States" (Light, 1997, p. 74).


54
Antidepressant: Medications
Antidepressant medications, such as tricyclic
antidepressants and monoamine oxidase (MAO) inhibitors, also
are used to treat children with ADHD. Tricyclic
antidepressants have a well-demonstrated ability in treating
behavioral symptoms (Popper, 1997). Desipramine
hydrochloride (i.e., Norpramin) and imipramine hydrochloride
(i.e., Tofranil) may be used to treat ADHD.
Monoamine oxidase (MAO) inhibitors often are effective
for symptoms related to the disorder (Rapoport, 1986;
Zametkin, Rapoport, Murphy, Linnoila, & Ismond, 1985).
However, they have potentially greater adverse reactions
than tricyclic antidepressants and require dietary
restriction and monitoring (Sarason & Sarason, 1984). The
United States Food and Drug Administration (FDA) has not
approved either tricyclic antidepressants or monoamine
oxidase (MAO) inhibitors for treating ADHD (Tan & Schneider,
1997) .
Antidepressants are not as widely used as stimulants
due to severe adverse reactions. One of the most serious
adverse reactions of tricyclic antidepressants is
tachycardia (Biederman, Gastfriend, Jellinek, & Goldblatt,
1985; Puig-Antich, Ryan, & Rabinovich, 1985), which can be


55
fatal with as few as 10 pills (Copeland & Copps, 1995).
Cardiac arrhythmias, anticholinergic effects, and sudden
death have also been reported (Ryan, 1990; Tan & Schneider,
1997). Desipramine hydrochloride also has been associated
with growth defects in children (Spencer, Biederman, Wright,
& Danon, 1992) and bone marrow depression (Block, 1996). The
long-term effectiveness of tricyclics in treating ADHD is
questionable (Copeland & Copps, 1995).
Additional Medications
The need for a variety of medications may be warranted,
given the diversity of children who present with symptoms of
ADHD and the limitations of their response to
psychostimulants alone (Hunt, Lau, & Ryu, 1991). Adderall is
one of the latest drugs being used for ADHD (Block, 1996).
Fluoxetine hydrochloride (i.e., Prozac) has been tried both
alone (Barrickman, Noyes, Kuperman, Schumacher, & Verda,
1991) and in combination with methylphenidate (Gammon &
Brown, 1993). Bupropion hydrochloride (i.e., Wellbutrin) is
successful in treating ADHD (Barrickman, Perry, Allen,
Kuperman, Arndt, Herrmann, & Schumacher, 1995; Casat,
Pleasants, Schroeder, & Parler, 1989; Simeon, Ferguson, &
Van Wyck Fleet, 1986), exerting both antiaggressive and
antihyperactive effects in some children (Hunt, Lau, Ryu,


56
1991). Clonidine hydrochloride (i.e., Catapres) can be
beneficial in treating ADHD symptomatology (Hunt, Minderaa,
& Cohen, 1985; Hunt et al., 1991; Wilens, Biederman, &
Spencer, 1994); guanfacine hydrochloride (i.e., Tenex)
reportedly is effective, less sedating, and longer acting
than clonidine hydrochloride (Hunt, Arnsten, & Asbell,
1995). A combination of drugs for children's sleep disorders
recently has been shown to alleviate the symptoms of ADHD,
including impulsive behavior and restlessness ("Sleep
Disorder," 1998).
Reasons For Not Using Medication as an Initial Treatment
While effective in many cases, medication is not
necessarily the best option as a first-line treatment of
ADHD. Other consideration must be made before this
intervention is utilized. Seven reasons have been suggested
as a rationale for not choosing medication as an initial
course of treatment (Copeland & Copps, 1995):
1. If medication is successful, there is little
incentive to try other interventions that are needed
for the long-term benefit of the child but require more
investment of time and energy from parents and
teachers.
2. Research suggests that those children receiving
medication alone did not have a better outcome by late
adolescence than those who never received treatment.


57
3. The amount of medication needed may be reduced after
a child's allergies are treated, stress is reduced,
organization, structure, and routine are implemented,
and behavior management strategies are used
effectively.
4. Parents are more comfortable with medication after
other alternatives have been tried and their child
continues to need intervention.
5. Children who may have been misdiagnosed or who do
not need medication typically are very obvious after a
few weeks of the use of other treatment.
6. Delaying medication insures adequate time to try
other interventions.
7. Medication is less likely to be over-utilized or
abused if important safeguards (e.g., careful
assessment) are followed.
Combining Medication with Other Interventions
Current research does not support sustained treatment
of ADHD with medication alone (Jacobvitz, Sroufe, Stewart, &
Leffert, 1990). Many professionals believe medication should
be used only after other appropriate interventions have been
tried (Coleman & Levine, 1988), and never should be the sole
treatment for ADHD (American Academy of Pediatrics, 1996).
As the only method of management, the value of stimulants is
limited (Pelham, 1993; Weiss, Kruger, Danielson, & Elman,
1975). At best, it is a short-term solution for many
children (Ialongo, Horn, Pascoe, Greenberg, Packard, Lopez,
Wagner, & Puttier, 1993) These limitations have led to an


58
adoption of multimodal treatment for children with ADHD
(Barkley, 1989a).
Evidence suggests that successful treatment of ADHD is
related to the extended use of multimodal treatment
(Rostain, Power, & Atkins, 1993). A combination of
pharmacological and psychosocial treatments or behavior
modification strategies is recommended since multiple
impairments require multiple treatment modalities (Bramlett,
Nelson, & Reeves, 1997; Swanson, Sergeant, et al., 1998).
Despite support for multimodal treatment among medical
practitioners, most children are prescribed Ritalin as their
only treatment (Price, 1996) .
The two most commonly used paired treatments are
stimulant medication and behavior modification (Barkley,
1990). The combination of these two has been found to be
more effective than either used in isolation (Bramlett et
al., 1997; Pelham & Murphy, 1986), and has been described as
an optimal treatment approach for ADHD (Barkley, 1990).
However, some believe medication alone is as effective as
medication used in combination with any other treatment
(Dawson, 1996). In practice, medication frequently is
administered without any behavioral interventions (Evans,
Ferre, Ford, & Green, 1995).


59
While multimodal treatment can lead to good outcomes,
there often is a lack of personnel who can research and
implement them. Thus, some child and adolescent services
will not accept referrals for ADHD. In addition, two recent
well-controlled studies question the effectiveness of this
multimodal approach (Ialongo et al., 1993; Pelham, Carlson,
Sams, Vallano, Dixon, & Hoza, 1993).
Opposition to the Use of Medications
Opposition to the use of medication to treat children
with ADHD arises from many sources. Adults feel apprehensive
about giving children drugs that affect brain functioning
and are used to control behavior (Copeland & Copps, 1995).
Medication may be used indiscriminately. For example,
children who are disruptive in the classroom may be treated
with Ritalin even though they do not have ADHD ("Are Too
Many Children," 1996). It appears the use of Ritalin may
depend on parents' and teachers' ability to tolerate
children's behavior (Bromfield, 1996a). Children who may
have been misdiagnosed or who do not need medication
typically are very obvious after a few weeks of other
treatment (Copeland & Copps, 1995). Methylphenidate
typically produces similar effects on children, even those
without ADHD (Breggin & Breggin, 1995). Many physicians are


60
using drugs as a diagnostic tool, believing that if the
child improves, he or she must have ADHD (Livingston, 1997).
This belief may lead a physician to prematurely end the
search for a more proper diagnosis without considering
disorders that coexist with ADHD and may jointly interfere
with a child's functioning (National Attention Deficit
Disorder Association, 1998).
Medication, and more specifically Ritalin, is the most
common treatment for children with ADHD (DuPaul & Rapport,
1993). Given recent trends in managed care, many primary
care physicians who prescribe medications often do not
consult with school personnel or other health care
professionals (McEwan, 1998). In addition, compliance with
pharmacologic treatment of ADHD often is inadequate
(Firestone, 1982; Sleator, 1985). Delaying medication
insures adequate time to try other interventions.
Several reasons have been given for not choosing
medication as an initial treatment (Copeland & Copps, 1995).
If medication is successful, there is little incentive to
try other interventions that are necessary for the long-term
benefit of the child but require more investment of time and
energy from parents and teachers. The amount of medication
needed may be reduced once a child's allergies are treated,


61
stress is reduced, organization, structure, and routine are
implemented, and behavior management strategies are used
effectively. And parents are more comfortable with
medication after other alternatives have been used and their
child continues to need intervention. Thus, many
considerations must be made before allowing a child to take
stimulant medication, including: adverse reactions, unknown
results from long-term use, abuse, ineffectiveness, and the
financial aspects of prescribing medication.
Adverse Reactions of Stimulant Medications
The majority of children treated with stimulants
experience some adverse reactions, ranging from mild to
severe (Efron et al., 1997). Insomnia, decreased appetite,
irritability, anxiety, headaches, and stomachaches occur in
20% to 50% of children treated with stimulant medication
(Goldstein & Goldstein, 1990). Some children may experience
a negative rebound effect at night once the medication wears
off, and symptoms often are worse than if the child had
never taken the medication (Reichenberg-Ullman & Ullman,
1996). Additionally, 3% of individuals cannot take Ritalin
because of biochemical intolerance (Jordan, 1998) Adverse
reactions are reversible with dosage reduction or drug
withdrawal (Bramlett et al., 1997), however, and all traces


62
of Ritalin are cleared from the brain within 24 hours of
cessation (Jordan, 1998). Many children must take multiple
medications in an effort to counteract chemically-induced
adverse reactions (Hunker, 1998).
The potential for severe adverse reactions from
stimulant medications must be considered. These may include
liver dysfunction (Barkley, 1995; Jordan, 1998; Tan &
Schneider, 1997), glaucoma (Armstrong, 1995), symptoms of
psychosis (Braswell & Bloomquist, 1991), anorexia
(Physician's Desk Reference, 1999), heart problems leading
to sudden death (Armstrong, 1995), leukopenia (Findling &
Dogin, 1998), depression (Breggin, 1998), motor and vocal
tics (DuPaul, Barkley, & Connor, 1998), and permanent facial
tics (Breggin & Breggin, 1995; Reichenberg-Ullman & Ullman,
1996; Tan & Schneider, 1997). The risk of triggering tics
associated with Tourette's Syndrome also is of major concern
(Cherkes-Julkowski, Sharp, & Stolzenberg, 1997; Shaywitz &
Shaywitz, 1991b), especially since this disorder is
irreversible (Patterson, 1996). However, stimulant
medications may only trigger tic disorders when a genetic
predisposition exists (Erenberg, Cruse, & Rothner, 1985).
The effect of stimulant medications on children's
height is another concern. A decrease in the rate of growth


63
occurs when Ritalin disrupts the cycles of growth hormone
released by the pituitary gland. This negative effect has
been recorded after only one or two years of treatment
(Greenhill, Puig-Antich, Chambers, Rubinstein, Halpern, &
Sachar, 1981). A significant decrease can occur after two to
four years of Ritalin use (Mattes & Gittelman, 1983). High
doses continuously consumed over a number of years are more
likely to suppress growth than lower doses (Sears &
Thompson, 1998). Nevertheless, height tends to normalize
during adolescence (Spencer, Biederman, Harding, O'Donnell,
Faraone, & Wilens, 1996).
Unknown Results From Long-term Use of Medications
The Physicians' Desk Reference (1999) acknowledges
there are insufficient data on the safety and efficacy of
long-term use of stimulants by children. Some children
receive drug treatment for extended periods of time without
proper evaluation by professionals (e.g., psychologists,
speech pathologists, educational diagnosticians) and without
continuing evaluation during their therapy (American Academy
of Pediatrics, 1996). Children in the United States also are
prescribed the drug for longer periods of time than children
in other countries ("Agency Survey," 1996).


64
The full effects stimulant medications will have on
children's bodies are unknown. There is concern that harmful
effects may occur many years after treatment ends. Few
children who were treated extensively with stimulant
medications have reached middle age (Jacobvitz et al.,
1990). Thus, follow-up research must be conducted to
determine possible deleterious effects.
Abuse
Ritalin has become a popular recreational drug
(Reichenberg-Ullman & Ullman, 1996). It has been referred to
as pediatric cocaine (Block, 1996). Ritalin is regulated by
the DEA in the same category as cocaine, morphine, PCP,
codeine, and methadone (Price, 1996). Schedule II controlled
substances such as Ritalin, drugs for which prescriptions
are carefully monitored, "have a high abuse potential with
severe psychological or physical dependence liability"
(DiGregorio & Barbieri, 1998, p. 263). One physician notes
the extensive procedure involved in prescribing and filling
the prescription, given its dangerous potential:
Doctors who prescribe it are required to obtain an
expensive narcotic license, renew it every two years,
and write the prescription (with annoying perfection)
on special triplicate prescription pads provided by the
DEA. The doctor retains a copy, the pharmacy retains a
copy, and the DEA retains a copy. ... A prescription
for Ritalin cannot be called into the pharmacy over the


65
phone; instead, the completed official prescription
form must be mailed or handed directly to the patient.
If the doctor forgets to cross a t or dot an i, the
pharmacist must send it back, for fear that someone may
have tampered with the prescription. The point is,
everyone involved with prescribing Ritalin takes it
seriously, especially the doctor, the pharmacist, and
the DEA. So must everyone else. (Sears & Thompson,
1998, p. 232)
Prescriptions for Ritalin have increased 600% since
1990, with a large portion of the drugs diverted for illicit
use (Bailey, 1995). The DEA has received reports of street
sales, drug rings, illegal importation, and illegal sales by
health professionals (Goldman et al., 1998). Ritalin has
ranked in the top 10 most frequently reported controlled
pharmaceuticals stolen from licensed handlers (Drug
Enforcement Administration, 1995).
Drug abuse injury reports involving Ritalin for
children ages 10 to 14 have increased 1,000% (Haislip,
1996). Psychotic episodes and violent behaviors are
associated with chronic abuse of Ritalin (Merline, 1997).
Ritalin-related visits to emergency rooms for 10-14 year
olds have increased 10-fold and now are at the same level as
cocaine (Haislip, 1996). Hospital admissions have increased
fivefold since 1990 (Merline, 1997).
The United Nations International Narcotics Control
Board has reported an increase in the number of teenagers


66
inhaling Ritalin (Bromfield, 1996b). A survey of high school
students indicated that more seniors in the United States
abuse Ritalin than are prescribed legitimately (Drug
Enforcement Administration, 1995). The number of high school
seniors who admitted abusing the drug doubled to 350,000
from 1993 to 1994 (Reichenberg-Ullman & Ullman, 1997). White
and suburban abusers are more likely to snort Ritalin, while
African-American inner-city abusers are more likely to
inject it (Bailey, 1995). As many as 15 to 20% of the
children in some communities have been placed on Ritalin or
a similar stimulant; thus, "there is good reason to conclude
that this is a 'quick-fix', bogus medical practice which is
nevertheless producing large profits" (Haislip, 1996, p. 2).
In the United States, ADHD is diagnosed most commonly
in wealthy suburbs where parents often expect their children
to be high academic achievers (Toufexis, 1989). There is the
potential for abuse by adolescents and their parents who
inappropriately seek stimulants to enhance the ability to
study for higher level exams (Mellor et al., 1996) or to
succeed in school (Debroitner & Hart, 1997). Abuse of
Ritalin can result in psychotic episodes, violent behavior,
tolerance, and severe psychological dependence (Price,
1996).


67
Ineffectiveness
Not all children with hyperactivity respond to
stimulant medication. As many as 40% may show no response
(Reichenberg-Ullman & Ullman, 1996), and those who do
respond may not respond fully (Williams & Cram, 1978). This
lack of response to its use may be attributed to the finding
that half of every dose of Ritalin may contribute nothing to
its therapeutic effect (Wu, 1998). One of two molecular
forms found in Ritalin was shown to offer little benefit,
while contributing to the drug's adverse reactions.
Among children who respond to stimulant medication,
drug therapy rarely is sufficient to bring them within a
normal range of academic and social functioning (Pelham,
1993). Some studies have failed to confirm improvement in
ADHD symptoms (McGuiness, 1989; Baughman, 1993; Breggin &
Breggin, 1994; Walker, 1996), including improvement in
retention of learning, overall achievement, or control of
anger (Weintraub, 1997). Several reasons have been offered
to explain this phenomenon: studies may be short-term,
dosages may have been inadequate, and dose-response
relationships may be different for different domains
(Goldman et al., 1998) .


68
Persons with a type of ADHD attributed to one etiology
do not respond to medication. Approximately 93% of children
with right hemisphere syndrome, one genetic form of ADHD,
display characteristics of ADHD (Voeller, 1986). Persons
with this common form of ADHD are very difficult to treat
with medications unless a drug-treatable comorbidity (e.g.,
conduct disorder, depression) exists (Popper, 1997) .
Despite decades of research, no demonstrable long-term
benefits of stimulant medication have been noted (Swanson &
Kinsbourne, 1980a). A lack of data showing continued or
lasting effects from medication suggest its long-term
effectiveness cannot be supported (Jacobvitz et al., 1990).
In addition, the effects from long-term use of stimulants on
children's growing bodies are unknown (Ullman, 1988).
Several explanations have been offered to account for a
lack of long-term benefits from the use of stimulant
medication (Jacobvitz et al., 1990). Drug treatment alone
may be an adequate treatment for most children. A tolerance
for the medication may develop and drug effects may
disappear over time. Children with attentional and
behavioral problems represent a very heterogeneous group. If
a subset has a specific biochemical abnormality, positive
effects of medication may be obscured.


69
Financial Aspect
One cannot overlook the financial aspect of medication.
Medicating children with ADHD at an early age often gains a
customer for life. Stimulant medications have been over
promoted, over-marketed, and over-sold, resulting in annual
profits of approximately $450 million (Haislip, 1996).
Because pharmaceutical companies are making large profits
from the diagnosis and treatment of ADHD, drug treatment is
unlikely to stop, even if drugs are found not to be the best
treatment (Block, 1996). There clearly is greater financial
profit in getting doctors, parents, and teachers to treat
the disorder with medication instead of other therapies
(Johnson, 1998).
Alternative Treatments
The popularity of complementary and alternative
medicines (CAM) has grown in recent years. The use of CAM
with children also is increasing (Spigelblatt, 1995). Visits
to alternative medicine practitioners in the United States
increased 47%, from 427 million in 1990 to 629 million in
1997 (Eisenberg, Davis, Ettner, Appel, Wilkey, Van Rompay, &
Kessler, 1998), compared to only 386 million visits to
primary-care physicians (Cowley & Underwood, 1998). Over
half of all conventional physicians in the United States use


70
or refer patients for alternative treatments (Astin, 1998;
Blumberg, Grant, Hendricks, Kamps, & Dewan, 1995; Ernst,
1995). An estimated $32.7 billion is spent annually on
services of practitioners of alternative therapies
(Eisenberg et al., 1998).
CAM are intended to be complementary and compatible
with conventional medicine. It includes practices requiring
highly specialized and competent practitioners, over-the-
counter products, and self-care techniques. Many patients
use alternative medicine either because they are attracted
to CAM philosophies and health beliefs, or because they are
not satisfied with the process or results of their
conventional care (Furnham & Forey, 1994).
Some believe every effort should be made to investigate
alternatives before beginning drug therapy (Friedman &
Doyal, 1992). In an attempt to find more natural treatments
for ADHD, many parents seek a complementary or alternative
treatment for their children (Spencer & Jacobs, 1999). A
number of these treatments for children with ADHD have been
utilized, with varying success, including iron treatment,
Feingold Diet, neurofeedback, homeopathy, herbal medicine,
and dietary supplements.


71
Iron Supplementation
Iron deficiency is the world's most prevalent
nutritional disorder (Weintraub, 1997). Evidence suggests
iron deficiency has behavioral effects (Sever, Ashkenazi,
Tyano & Weizman, 1997). A deficiency affects motor behaviors
and cognitive function, and iron level may play a part in
motor hyperactivity, poor cognitive learning, and attention
deficit. Many children with ADHD have low levels of iron and
other trace elements, and the use of iron treatment for a
deficiency significantly improves behavior and intellectual
attainment (Deinard, Murray, & Egeland, 1976; Pollitt &
Leibel, 1976; Weintraub, 1997; Yehuda, Youdim, & Matofsky,
1986). There also may be some benefit to iron
supplementation in ADHD children who are non-iron-deficient
(Sever et al., 1997).
Feingold Diet
The Feingold Diet was created to teach parents how
children with behavioral, learning, and health problems can
be helped by the elimination of certain foods and synthetic
chemicals. The two stage elimination diet was created by
pediatrician Ben Feingold (Feingold Association, 1983). The
first stage (Table 1) involves an initial period when foods
containing synthetic colors and flavors, antioxidant


72
Table 1
Feingold Diet, Stage 1
Initial period during which two groups of foods are
eliminated.
Group 1: Eliminate foods containing:
Synthetic colors. Listed as "U.S. Certified
Color," or by its FDA number, such as "FD&C Yellow
No. 5."
Synthetic favors. May be listed as "flavoring" or
"artificial flavoring."
Three antioxidant preservatives:
BHA (Butylated Hydroxyanisole)
BHT (Butylated Hydroxytoluene)
TBHQ (Monotertiary Butylhydroxylquinone)
Group 2: Eliminate foods containing natural
salicylates, such as:
Almonds
Apples
Apricots
Cherries
Cucumbers
Grapes and raisins
Green peppers
Oranges
Peaches
Plums
Tea
Tomatoes
Aspirin and medication containing aspirin also are
eliminated.
Source: Feingold Association. (1983) Feingold handbook,
page 3. Alexandria, VA: Feingold Association.


73
preservatives, and natural salicylates are eliminated. The
second stage (Table 2) includes a reintroduction of foods
with natural salicylates. Foods are added and tested
individually to determine if the child can use some or all
of them without a negative change in behavior.
Feingold's proposed diet received widespread support
despite a lack of corroborating controlled clinical trials,
and many parents were convinced their children were reacting
adversely to ingested synthetic colorings (Rowe, 1988). Five
factors have been suggested to account for the
attractiveness of Feingold's hypothesis (Williams & Cram,
1978): it offers a natural alternative to drug therapy, it
alleviates the guilt parents feel by putting the blame on
food, it removes blame from the schools, it is consistent
with the growing awareness of ecology and pure foods, and it
allows parents to control their child's diet, thus enabling
them to become the primary therapeutic agents. In addition,
parents are attracted to the diet treatment because of
dissatisfaction with other therapies (Harley & Matthews,
1978) .
Research investigating food additives as the cause of
hyperactivity or learning problems in children has been
mixed (Conners, 1980a, 1980b; Lipton & Mayo, 1983; Mattes,


74
Table 2
Feingold Diet, Stage 2
After a favorable response has been observed for four to six
weeks, the foods in Group 2 may be carefully reintroduced
and tested one at a time. Foods in Group 1, from Stage 1,
are never reintroduced.
Examples of Fruits Allowed:
Banana
Cantaloupe
Dates
Grapefruit
Lemons
Limes
Papaya
Pears
Pineapple
Watermelon
Examples of Vegetables Allowed:
Asparagus Onions
Beans (all types) Peas
Broccoli Potatoes, white and sweet
Carrots Pumpkin
Celery Spinach
Lettuce Squash
Source: Feingold Association. (1983). Feingold handbook,
page 4. Alexandria, VA: Feingold Association.
1981; Wender, 1986). Empirical research (e.g., Boris &
Mandel, 1994; Carter, Urbanowicz, Hemsley, Mantilla,
Strobel, Graham, & Taylor, 1993; Egger, Carter, Graham,
Gumley, & Soothill, 1985; Egger, Stolla, & McEwen, 1992;
Kaplan, McNicol, Conte, & Moghadam, 1989a; Pollock & Warner,
1990; Rowe & Rowe, 1994; Salzman, 1976) and anecdotal


75
reports (e.g., Cook & Woodhill, 1976; Swanson & Kinsbourne,
1980b; Weintraub, 1997; Williams, Cram, Tausig, & Webster,
1978) support Feingold's theory. Evidence suggests from 30
to 50% (Feingold, 1976) of children on the Feingold diet
display behavioral improvement. However, many empirical
studies have either discredited this relationship or yielded
inconclusive results (e.g., Connors, Goyette, Southwick,
Lees, & Andrulonis, 1976; Cook & Woodhill, 1976; David,
1987a; Goyette, Connors, Petti, & Curtis, 1978; Gross,
Tofanelli, Butzirus, & Snodgrass, 1987; Harley, Matthews, &
Eichman, 1978; Harley, Ray, Tomasi, Eichman, Matthews, Chun,
Cleeland, & Traisman, 1978; Levy, Dumbrell, Hobbes, Ryan,
Wilton, & Woodhill, 1978; Mattes, 1980; Mattes, & Gittleman,
1981; Mattes & Gittelman-Klein, 1978; Rowe, 1988; Weiss,
Williams, Margen, Abrams, Caan, Citron, Cox, McKibben, Ogar,
& Schultz, 1980; Williams, Cram, Tausig, et al., 1978).
Ironically, while many are skeptical of the relationship
between artificial colors and ADHD, the Physicians' Desk
Reference (1999) notes Ritalin sustained-release tablets are
available in a color-additive free form.
These data may not offer an accurate interpretation.
Some results are questionable because of logistic and
methodologic problems (Conners, 1980b; National Advisory


76
Committee on Hyperkinesis and Food Additives, 1980; Rippere,
1983). Impediments include the lack of a control group
(Tryphonas, 1979), uncertainties about which part of the
diet is of significance (Rowe, 1988), parental
identification of differences between the Feingold and
placebo diets (Conners et al., 1976), dietary compliance
(Gross et al., 1987; Tryphonas, 1979), possible lack of
inertness of the control substance (Rippere, 1983), varying
diagnostic criteria for hyperactivity (American Psychiatric
Association, 1968, 1980, 1987, 1994; Biederman, Newcorn, et
al., 1991; Halpern et al., 1992; Hinshaw, 1987; Pliszka,
1992; Shaywitz & Shaywitz, 1991a; World Health Organization,
1978), identification of responding children from
heterogeneous populations (Rowe, 1988), placebo or
"Hawthorne" effect (Brenner, 1977; Spring & Sandoval, 1976;
Wender, 1977; Williams, Cram, Tausig, et al., 1978), the
expense and difficulty of satisfactorily implementing
double-blind conditions (Conners et al., 1976; Harley, Ray,
et al., 1978; Williams, Cram, Tausig, et al., 1978), doubts
about the validity and reliability of outcome measures (Rowe
& Rowe, 1992), insufficient dependent measures to assess
treatment effects (Trites et al., 1980), and detection of
treatment effects when only a small number of children


77
respond (Cox, 1981; Dews, 1982/1983; Harley, 1981; Rowe,
1988; Schwab & Conners, 1986).
Several concerns have been raised with regards to
children being placed on the Feingold Diet without physician
supervision (David, 1987b). Children have suffered
anaphylactic reactions to certain dietary elements that were
previously restricted from their diet. They may be starved
of essential nutrients by highly-restricted diets
implemented by parents. Dietary treatment is expensive and
requires the time of several medical personnel. In addition,
restricting the child's diet can be unrealistic and
impossible to monitor outside of the home.
Two groups worked independently to address the claims
of Feingold's hypothesis. The National Commission on
Hyperkinesis and Food Additives was established by the
Nutrition Foundation, a group formed by the food industries
in the United States. The Interagency Collaborative Group on
Hyperkinesis was created by the United States Department of
Health, Education and Welfare. The groups reached the
following conclusions (Williams & Cram, 1978): the
hypothesis was based on clinical findings and not on
rigorous clinical trials or experimental research, the
hypothesis was derived from intuitions and clinical


78
experience rather than being based on the scientific
principles of biochemistry and nutrition, and systematic
clinical trials and strict experimental designs were
required to test the hypothesis and the effectiveness of the
diet.
Neurofeedback
The term "biofeedback" was first used in the 1960s. It
describes procedures used to train research subjects to
alter their brain activity, blood pressure, heart rate, and
other functions not normally voluntarily controlled (Runck,
1983). The treatment technique allows individuals to improve
their health by using signals from their own bodies.
Neurofeedback, or EEG biofeedback, training has been
applied to a number of neurological, psychological, and
psychosomatic conditions (e.g., Hartje, 1980; James & Folen,
1996; Tansey, 1993). The goal of neurofeedback is to improve
mental flexibility so a person can produce a mental state
appropriate for a particular situation (e.g., completing
classwork) (Sears & Thompson, 1998). Research has
established the effectiveness of neurofeedback in treating
individuals with ADHD (Lubar & Shouse, 1976; Othmer, 1997).
It is one of the fastest-growing applications of biofeedback
and a relatively new approach to the treatment and long term


79
management of ADHD (Othmer, Kaiser, & Othmer, 1995), and
neurofeedback generally is accepted by allopathic physicians
(Laken & Cosovic, 1995).
Differences in EEG are present in children with ADHD
and those without the disorder (Kuperman et al., 1996;
Lazzaro, Gordon, Whitmont, Plahn, Li, Clarke, Dosen, &
Meares, 1998; Lubar, 1991; Othmer & Othmer, 1992a).
Neurofeedback has been found to remediate the underlying
condition of physiological underarousal in hyperactivity
(Lubar & Lubar, 1976). Thus, symptoms of ADHD may arise from
a disregulated EEG, in combination with genetics, trauma,
and other factors that can be attributed to the onset of the
disorder (Othmer & Othmer, 1992a).
Neurofeedback can help ameliorate the problems
associated with ADHD (Lubar, 1995) (Table 3). It is a method
for repeatedly exercising the pathways of attention and
impulse control, thereby facilitating their growth and
development (Sears & Thompson, 1998). The use of
neurofeedback has resulted in increased attention, impulse
control, and speed of information processing on the Test of
Variables of Attention (Cartozzo, Jacobs, & Gevirtz, 1995;
Kaiser, 1997; Kaiser & Othmer, 1997; Rossiter & LaVaque,
1995; Scheinbaum, Zecker, Newton, & Rosenfield, 1995) and


80
Table 3
Application of and Results from Neurofeedback Treatment
Anyone with a primary diagnosis of ADD or ADHD, between the
ages of 7 and 45, with low-average, average, or above-
average intelligence is a candidate. Neurofeedback treatment
should not be offered with comorbidity of:
Mental retardation
Childhood psychosis
Severe depressive or bipolar illness
Significant seizure disorder where medications
interfere with learning (i.e., sedating
medications)
Hyperkinesis, where multiple medications or high
dosage with monotherapy have been ineffective
Learning disabilities without ADD and ADHD as a
primary problem
Dysfunctional families who refuse to participate
in indicated therapy
Symptoms that can be improved with neurofeedback:
Attention, focus, and concentration
Task completion and organizational skills
Impulsivity
Mild hyperactivity
Results of treatment:
Improved behavior and learning
Improvement in school grades
Increased self-esteem
Better job performance
Greater realization of innate potential
Higher intelligence test scores
Improved scores on parent-teacher rating scales
Source: Lubar, J. F. (1995). Neurofeedback for the
management of attention-deficit/hyperactivity disorders. In
M. Schwartz, Biofeedback: A practitioner's guide, pp. 506-
507. New York: Guilford Press.


81
improved scores on the Freedom from Distractibility factor
of the Wechsler Intelligence Scale for Children-Revised
(Cartozzo et al., 1995). Behavior Assessment Scale for
Children (BASC) questionnaires completed by mothers also
confirm a reduction in ADHD symptoms (Rossiter & LaVaque,
1995). Results indicating a significant reduction of
symptoms are consistent with other studies (Linden, Habib, &
Radojevic, 1996; Lubar, 1991; Lubar, Swartwood, Swartwood, &
O'Donnell, 1995). Research indicates the success rate for
biofeedback training is approximately 85% (Sears & Thompson,
1998). Although the treatment has been used successfully
with more than 3000 children in over 300 health care
organizations (Lubar, 1995), Russell Barkley, an expert in
the field of ADHD research, disputes the claims of
neurofeedback as an effective intervention (personal
communication, February 16, 1998).
Homeopathy
Homeopathy is the method of using any of more than
2,000 remedies with the power to resonate with the illness,
in contrast with the more traditional method of opposing
symptoms with great force (Jacobs & Moskowitz, 1996). The
medical theory and practice developed in reaction to the
bloodletting, blistering, purging, and other harsh


82
procedures of conventional medicine as it was practiced 200
years ago (Stehlin, 1997). Samuel Hahnemann, an 18th century
German physician and chemist discouraged with these methods,
developed a theory based on three principles: the law of
similars, the minimum dose, and the single remedy (Jacobs &
Moskowitz, 1996) .
The law of similars states that if a large amount of a
substance causes certain symptoms in a healthy person,
smaller amounts of the same substance can be used to treat
the symptoms in an ill person (Reichenberg-Ullman & Ullman,
1996). Since symptoms are defenses of the body, it is best
to aid rather than suppress them (Ullman, 1988) .
Conventional medicine applies this principle to
immunizations and allergy treatments.
Homeopathic remedies stimulate an ailing self-healing
mechanism rather than correcting a specific problem; thus,
large doses rarely are required and may even spoil the
effect (Jacobs & Moskowitz, 1996). With a minimum dose, the
strength and effectiveness of a substance increases the more
it is diluted. Small doses decrease any chance that
dangerous adverse reactions will occur.
A single remedy generally covers all of the symptoms a
patient is experiencing (Stehlin, 1997). Remedies made from


83
a variety of sources (e.g., plants, minerals, animals) are
prescribed based on a person's symptoms. The use of multi
ingredient remedies is recognized as part of homeopathic
practice.
Homeopathy is widely used to treat a variety of health
problems. Approximately 500 million people worldwide receive
homeopathic treatment (Burton Goldberg Group, 1997), and it
is the second most popular form of CAM used by children
(Spencer & Jacobs, 1999). Treatments have been shown to be
effective for both common and chronic ailments, such as
allergies (Reilly, Taylor, McSharry, & Aitchison, 1986;
Wiesenauer & Ludtke, 1995), asthma (Reilly, Taylor, Beattie,
Campbell, McSharry, Aitchison, Carter, & Stevenson, 1994),
childhood diarrhea (Jacobs, Jimenez, Gloyd, Gale, &
Crothers, 1994), fibromyalgia (Fisher, 1986; Fisher,
Greenwood, Huskisson, Turner, & Belon, 1989), hyperactivity
(Frederick, 1998; Reichenberg-Ullman, 1997; Ullman, 1988),
influenza (Davies, 1971; Ferley, Zmirou, DAdhemar, &
Balducci, 1989), irritable colon (Owen, 1990), migraines
(Brigo & Serpelloni, 1991), and rheumatoid arthritis
(Gibson, Gibson, MacNeill, & Buchanan, 1980) Two doctors of
naturopathy claim a 70% success rate using homeopathic
methods for at least one year with nearly 1,000 children


84
with ADHD (Reichenberg-Ullman & Ullman, R., 1996). Evidence
supporting its efficacy in placebo controlled-trials is
surfacing (Linde, Clausius, Ramirez, Melchart, Eitel,
Hedges, & Jonas, 1997). A meta-analysis of 25 years of
controlled clinical studies using homeopathic medicines
produced the following results: 81 showed homeopathic
medicines were effective, 24 showed they were ineffective,
and 2 were inconclusive (Kleijnen, Knipschild, & ter Riet,
1991) .
The use of homeopathy has increased over the last few
decades, and its popularity is evidenced throughout the
world, especially in Europe, Latin American, and Asia
(Jacobs & Moskowitz, 1996). One-fourth of all physicians in
Germany use homeopathy (Ullman, 1991), while one-third of
general practice physicians in France engage in its use
(Bouchayer, 1990). Sales of homeopathic remedies in the
United States increased by 1,000 percent during the 1980s
(Jacobs & Moskowitz, 1996). In 1995, retail sales of these
medicines were estimated at $201 million and growing at a
rate of 20 percent (Stehlin, 1997) .
Herbal Medicine
Interest in and actual use of herbs has dramatically
increased during the last two decades. Fifteen years ago,


85
none of the top 250 pharmaceutical companies had a program
to investigate plant-based medicines, although over half now
have programs to examine their efficacy (Vincent & Furnham,
1997). Despite the utilization of a large number of herbal
medicines, less than 10% of the estimated 250,000 flowering
plant species have been investigated for their scientific
potential (Vincent & Furnham, 1997). Thus, choosing new
herbs for investigation can be difficult. Research continues
to uncover possible treatments and cures among these plants,
guided by knowledge of the plants currently used by
different cultural groups for medical purposes (Meserole,
1996) .
Herbal remedies are growing in popularity in the United
States. Americans spent $12 billion for herbis, vitamins,
minerals, and sports and speciality supplements in 1997
("Herbal Rx," 1999). This figure is approximately 30%
greater than that from two years earlier.
Herbal medicines offer a viable alternative treatment
for a variety of disorders (Cassileth, 1998). They have
earned the attention of parents and medical professionals
interested in finding an alternative to pharmacological
treatment of ADHD (Weintraub, 1997). Researchers have
identified two particular herbs, Ginkgo biloba and lemon


86
balm, that are useful in treating symptoms commonly
associated with ADHD (Weintraub, 1997).
Ginkgo biloba
Ginkgo biloba is one of the oldest living tree species,
dating back over 200,000 years. Much of the tree's original
territory was wiped out during the last Ice Age, although
today the tree survives in northern China and Japan (Burton
Goldberg Group, 1997). In China, extracts of the fruit and
leaves of the Ginkgo tree have been used as a remedy for
over 1,000 years (Pang, Pan, & He, 1996).
In Germany, Ginkgo extracts are among the most widely
used herbal medicines (Jones, 1998). Because the extract
increases blood circulation to the brain and increase oxygen
levels in brain tissues, it is used primarily in an effort
to improve mental clarity and alertness (Hobbs, 1991). It
also has been shown to improve the cognitive function of
demented patients (LeBars, Katz, Berman, Itil, & Freedman,
1997) .
The treatment is somewhat effective for disorders of
the brain, such as dementia and memory impairment ("Boost
Brain Power," 1998; Itil & Martorano, 1995; Kanowski,
Herrmann, Stephan, Wierich, & Horr, 1996; LeBars et al.,
1997; Oken, Storzbach, & Kaye, 1998; Pang et al., 1996; Rai,


87
Shovlin, & Wesnes, 1991; Soholm, 1998). In a review of 40
controlled trials, nearly all trials reported at least a
partial positive outcome in patients with cerebral
insufficiency (Kleijnen & Knipschild, 1992). Cerebral
insufficiency is a general term for a collection of symptoms
that include difficulties of concentration and memory,
absentmindedness, confusion, lack of energy, depressive
mood, anxiety, dizziness, tinnitus, and headache.
Melissa officinalis
Melissa officinalis, or lemon balm, contains nervine
principles that help restore the balance and function of the
brain and nerve cells. It has a mild relaxing effect, making
it a good treatment for children with hyperactivity
(Anderson & Peiper, 1996; Klein, 1998; Mendola, 1996) and
other symptoms related to ADHD (Bell & Peiper, 1997).
Dietary Supplements
Dietary supplements are used to treat a variety of
disorders and, because they are readily available, are used
by parents wishing to self-treat their children (Weintraub,
1997). Supplements do not cure a disorder; rather, they
treat the symptoms and underlying causes. Many dietary
supplements are used to treat ADHD symptomatology, and


88
popular choices include grapine, dimethylaminoethanol, L-
Glutamine, and an essential fatty acid.
Grapine
Grapine is derived from both the bark of the French
Maritime Pine tree and grape seed (Elkins, 1995). Grapine is
very similar to Pycnogenol, a nutritional compound from
France once comprised only of the tree bark but now also
derived from grape seeds (Walji, 1996). Original research
showing the power of Pycnogenol was done with grape seed
extract and is essentially equivalent in function (Eidelman,
1997).
Children with ADHD have found grapine somewhat
effective in decreasing their symptoms by normalizing brain
function (Rapp, 1998; Weintraub, 1997). It is a high potency
antioxidant known to cross the blood-brain barrier to
facilitate the flow of oxygen to the brain and central
nervous system, improving problems with inattentiveness and
hyperactivity (Anderson & Peiper, 1996), as well as memory,
recall, and concentration (Bell & Peiper, 1997). It often is
used in France to control symptoms of ADHD. Many Americans
are using it as an alternative to Ritalin (Debroitner &
Hart, 1997).


Full Text

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THE USE OF A DIETARY SUPPLEMENT COMBINATION AND AN ESSENTIAL FATTY ACID AS AN ALTERNATIVE AND COMPLEMENTARY TREATMENT FOR CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) By ALAN W. BRUE A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 1999

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ACKNOWLEDGMENTS Thank you to my doctoral committee members for their assistance during the completion of this dissertation, especially my committee chair, Dr. Thomas Oakland, for his help and guidance throughout my graduate studies. His untiring work ethic is an inspiration. Ors. John Kranzler, Mary Kay Dykes, and Barry Guinagh were helpful and supportive. Their insightful comments were very useful in preparing my dissertation, and I appreciate their assistance. Thanks to Dr. Robert Evans, Bonnie Snyder, and other members of the study team for their assistance throughout this project. And special thanks to the children, parents, and teachers who participated in the study, for without them this research would not have been possible. Most of all I would like to thank my friends and family, and especially my wife, Dawn, for their support throughout my graduate studies. ii

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TABLE OF CONTENTS ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . ii LIST OF TABLES. . . . . . . . . . . . . . . . . . . . . vi ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . ix CHAPTERS ONE INTRODUCTION . . . . . . . . . . . . . . . . . . 1 Statement of the Problem........................ 1 Purpose of the Study. . . . . . . . . . . . . . 3 Procedures . . . . . . . . . . . . . . . . . . . 3 Trial I Hypotheses. . . . . . . . . . . . . . . 6 Trial II Hypotheses. . . . . . . . . . . . . . . 7 Overview . . . . . . . . . . . . . . . . . . . . 8 TWO REVIEW OF RELATED LITERATURE .................... 10 His tori cal Views . . . . . . . . . . . . . . . . 10 Theoretical Views ............................... 11 Characteristics ......................... .'. . . . 13 Prevalence . . . . . . . . . . . . . . . . . . . 15 Incidence. . . . . . . . . . . . . . . . . . . . 1 7 Etiology . . . . . . . . . . . . . . . . . . . . 18 Diagnosis. . . . . . . . . . . . . . . . . . . . 32 Assessment. . . . . . . . . . . . . . . . . . . 37 Problems Associated with ADHD Symptoms .......... 44 Pharmacological Intervention .................... 50 Reasons For Not Using Medication as an Initial T rea tmen t . . . . . . . . . . . . . . . . . . 5 6 Combining Medication with Other Interventions ... 57 Opposition to the Use of Medications ............ 59 Alternative Treatments .......................... 69 iii

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THREE FOUR FIVE Classroomand Home-based Interventions ......... 91 Purpose of the Study ............................ 107 METHODOLOGY . . . . . . . . . . . . . . . . . . 10 9 Selection of Participants ....................... 112 Procedures . . . . . . . . . . . . . . . . . . . 114 Ins trumen ta tion. . . . . . . . . . . . . . . . . 11 7 Assignment of Participants ...................... 123 Treatments . . . . . . . . . . . . . . . . . . . 12 4 Administration. . . . . . . . . . . . . . . . . 128 Trial I Hypotheses . . . . . . . . . . . . . . 12 9 Trial II Hypotheses . . . . . . . . . . . . . . 130 Data Analysis Procedures ........................ 132 ANALYSIS OF THE DATA ............................ 134 Trial I Results ................................. 134 Trial II Results. . . . . . . . . . . . . . . . 141 Additional Findings . . . . . . . . . . . . . . 150 DISCUSSION AND RECOMMENDATIONS .................. 155 Discussion of the Results ....................... 155 Study Limitations. . . . . . . . . . . . . . . . 167 Recommendations for Future Research ............. 170 APPENDICES A ADHD RESEARCH PROTOCOL .......................... 172 B ORLANDO REGIONAL HEALTHCARE SYSTEM INSTITUTIONAL REVIEW BOARD FACT SHEET ......... 182 C ORLANDO REGIONAL HEALTHCARE SYSTEM INSTITUTIONAL REVIEW BOARD APPROVAL ....... .... 187 D UNIVERSITY OF FLORIDA INSTITUTIONAL REVIEW BOARD APPROVAL ................................ 190 E STUDY PARTICIPANT INFORMATION FORM .............. 192 F INFORMED CONSENT FORM ........................... 204 iv

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REFERENCES . . . . . . . . . . . . . . . . . . . . . . . 211 BIOGRAPHICAL SKETCH ..................................... 260 V

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LIST OF TABLES Table 1 Feingold Diet, Stage 1 .......................... 72 2 Feingold Diet, Stage 2 .......................... 74 3 Application of and Results from Neurofeedback Treatment. . . . . . . . . . . . . . . . . . . 8 0 4 Effective Interventions for Children with Attention Deficits. . . . . . . . . . . . . . 93 5 DSM-IV Criteria for a Diagnosis of ADHD, Combined Type . . . . . . . . . . . . . . . . 110 6 Participants by Assignment, Age Group, and Gender After Attrition ........................ 112 7 Parent and Teacher Data Collections by Participants' Age Group and Gender ............ 115 8 DSM-IV: Inattentive Subscale Items from the CRS R : L . . . . . . . . . . . . . . . . . . . 116 9 DSM-IV: Hyperactive-Impulsive Subscale Items from the CRS-R: L. . . . . . . . . . . . . . . 118 10 Psychometric Properties of the CRS-R:L .......... 122 11 Number and Mean Age of Participants in Each Group After Attrition ......................... 124 12 Trial I Parent Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin. . . . . . . . . . . . . . . . . . . . 135 vi

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13 Trial I Teacher Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin. . . . . . . . . . . . . . . . . . . . 135 14 Trial I Parent Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin ....................................... 136 15 Trial I Teacher Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin ....................................... 137 16 Trial I Parent Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Not Taking Ritalin ............................ 138 17 Trial I Teacher Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Not Taking Ritalin ............................ 139 18 Trial I Parent Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Taking Ritalin. . . . . . . . . . . . . . . . 140 19 Trial I Teacher Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Taking Ritalin. . . . . . . . . . . . . . . . 141 20 Trial II Parent Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin. . . . . . . . . . . . . . . . . . . . 142 21 Trial II Teacher Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin ....................................... 143 22 Trial II Parent Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin ....................................... 144 23 Trial II Teacher Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin ....................................... 146 vii

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24 Trial II Parent Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Not Taking Ritalin ............................ 147 25 Trial II Teacher Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Not Taking Ritalin ............................ 148 26 Trial II Parent Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Taking Ritalin. . . . . . . . . . . . . . . . 149 27 Trial II Teacher Results From the DSM-IV: Hyperactive-Impulsive Subscale for Children Taking Ritalin. . . . . . . . . . . . . . . . 150 28 Ritalin vs. Non-Ritalin Group Comparisons for the DSM-IV: Inattentive and DSM-IV: Hyperactive-Impulsive Subscales ............... 152 29 Treatment vs. Control Group Comparisons for the DSM-IV: Inattentive and DSM-IV: HyperactiveImpulsive Subscales ........................... 154 viii

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Abstract of Dissertation Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy THE USE OF A DIETARY SUPPLEMENT COMBINATION AND AN ESSENTIAL FATTY ACID AS AN ALTERNATIVE AND COMPLEMENTARY TREATMENT FOR CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) By Alan W. Brue August 1999 Chairman: Thomas D. Oakland, Ph.D. Major Department: Foundations of Education The study investigated the efficacy of the use of a dietary supplement combination (i.e., Ginkgo biloba, Melissa officinalis Grapine, dimethylaminoethanol, and L-Glutamine) and an essential fatty acid (i.e flaxseed) as a treatment for qualities relevant to attention deficit hyperactivity disorder (ADHD) (i.e., inattentiveness and hyperactivityimpulsivity) Its goal was to provide empirical evidence regarding their effectiveness in reducing ADHD-related behaviors in children diagnosed with this disorder. Sixty participants initially were chosen to participate in two 12-week trials Thirty participants were chosen ix

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randomly from those not taking Ritalin, and thirty participants were chosen randomly from those taking Ritalin. After attrition, fifty-one children completed both trials, among whom 25 were in the non-Ritalin group and 26 were in the Ritalin group. During Trial I, the dietary supplement combination was not more effective than a placebo at ameliorating children's inattentiveness and hyperactivity-impulsivity. Results from Trial II were mixed. Among children taking Ritalin, those who received the double dietary supplement combination displayed less inattentive behaviors than those who received the double dietary supplement combination plus an essential fatty acid based on teacher reports. Also, among children not taking Ritalin, those who received the double dietary supplement combination plus an essential fatty acid displayed less hyperactive-impulsive behaviors than those who received the double dietary supplement combination based on parent reports. However, those who received the double dietary supplement combination displayed less hyperactive impulsive behaviors than those who received the double dietary supplement combination plus an essential fatty acid based on teacher reports. Thus, these ingredients may not be X

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a reliable and effective alternative to or complementary treatment of ADHD. xi

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CHAPTER ONE INTRODUCTION Most children are active, energetic, and move from one activity to the next. They may become bored easily with tasks offering no reward, and often require considerable self-discipline to sit still and finish them. However, some children live in a world of disorganized and frenzied activities. They display levels of activity that far exceed their age group. Their ability to sustain interest or persistence as well as their peers is a challenge. Many of these children have been diagnosed with an attention deficit hyperactivity disorder (ADHD). Statement of the Problem Stimulant medication (e.g., Ritalin, Dexedrine, Cylert) is the most commonly used treatment for ADHD (Epstein, Singh, Luebke, & Stout, 1991). Ritalin is prescribed in more than 90% of children with ADHD who receive stimulant medication (DuPaul & Stoner, 1994; Goldman, Genel, Bezman, & Slanetz, 1998). The number of people taking Ritalin doubled between 1993 and 1995, and about three-fourths of the 2.6 1

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million consumers of Ritalin are children aged 5 to 12 with ADHD (Price, 1996). The United States Drug Enforcement Administration (DEA) has expressed alarm at the large increase in the number of prescriptions for stimulant medications in recent years (Haislip, 1996). While 70% to 80% of the children taking stimulant medications will find them somewhat effective (Buncher, 1996), the majority will experience mild to severe adverse drug reactions (Efron, Jarman, & Barker, 1997). Severe adverse reactions may include liver dysfunction (Barkley, 1995; Jordan 1998; Tan & Schneider, 1997), glaucoma (Armstrong, 1995), symptoms of psychosis (Braswell & Bloomquist, 1991), anorexia (Physicians' Desk Reference, 1999), heart problems leading to sudden death (Armstrong, 1995), and permanent facial tics (Breggin & Breggin, 1995; Reichenberg-Ullman & Ullman, 1996; Tan & Schneider, 1997). 2 Parents increasingly are seeking effective, natural alternative or complementary treatments for their children with ADHD. Many do not wish to expose their children to medications whose adverse reactions may lead to irreversible health problems. The Physicians' Desk Reference (1999) acknowledges there are insufficient data on the safety of long-term stimulant use by children.

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Purpose of the Study The purpose of this study was to investigate the efficacy of the use of a dietary supplement combination (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, and L-Glutamine) and an essential fatty acid (i e flaxseed) as a treatment for qualities relevant to ADHD (i.e., inattentiveness and hyperactivity impulsivity) Its goal was to provide empirical evidence with respect to their effectiveness in treating children with this disorder Procedures Parents of children ages 4 through 12 were invited as potential participants. They were self-referred or referred by pediatricians, psychologists, psychiatrists, or educators. Children were required to have a previous diagnosis of ADHD, Combined Type as established by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (American Psychiatric Association, 1994). Those receiving medication for their ADHD must have been taking Ritalin. Parents of candidates completed a Study Participant Information Form. This form was used to obtain information in many areas, including developmental, medical, and 3

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4 nutritional histories. Those candidates with other pre existing diagnoses (e.g., asthma, depression) were not considered, as pre-existing conditions often require regular use of medication as a treatment. Sixty candidates initially were chosen to participate. Thirty participants were chosen randomly from those not taking Ritalin, and thirty participants were chosen randomly from those taking Ritalin. The medical record of each participant was reviewed by the study physicians. Parents of children whose primary care physician were treating them were asked to request a blood analysis and to provide a copy of the child's last physical examination. Participants taking Ritalin continued to receive it as prescribed by their physicians. It was explained to parents that they could withdraw their child from the study at any time. Parents also were told to notify the physician in charge of the study if their child's Ritalin dosage was modified or if medication was changed from Ritalin to any other medication to treat ADHD. These conditions led to an administrative withdrawal of children from the study. Participants' parents were asked to complete a Conners' Parent Rating Scale-Revised: Long Form (Conners, 1997a). The

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teachers with whom participants spent most of their school day were asked to complete a Conners' Teacher Rating Scale Revised: Long Form (Conners, 1997a). The intervention consisted of two 12-week trials, hereafter called Trial I and Trial II. Within each trial were two experimental and two control groups. Prior to the beginning of Trial I, participants not taking Ritalin were assigned randomly to either the non-Ritalin treatment group or the non-Ritalin control group. Participants taking Ritalin were assigned randomly to either the Ritalin treatment group or the Ritalin control group. 5 During Trial I, participants in the treatment groups received a dietary supplement combination with the following ingredients and dosages: Ginkgo biloba 10 mg, Melissa officinalis 200 mg, Grapine 30 mg, dimethylaminoethanol 35 mg, and L-Glutamine 100 mg. Participants in the control groups received an inactive slippery elm supplement (220 mg) as a placebo. Trial II was implemented following the completion of Trial I, using the same subjects from the first trial. Subjects remained in their cohort group; only the treatment changed. During Trial II, all participants received a dietary supplement combination whose concentration was

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doubled. Additionally, the two treatment groups (formerly control groups) received an essential fatty acid (i.e., flaxseed) with their combination. The double dietary supplement combination, a uniform intervention received by all participants, helped to detect any significant differences in the groups of participants who received this essential fatty acid. 6 Nine children were withdrawn from the study during Trial I. The reasons for withdrawal were: parental choice (n = 6), change in Ritalin dosage (n = 1), and participants stopped taking Ritalin (n = 2). After attrition during the first trial, 51 children remained with the study until it ended (i.e., they completed both trials). Females comprised 14% (n = 7) of the remaining participants. The mean age of all remaining participants was 8.4 years. Trial I Hypotheses The study proposed the following hypotheses for Trial I in reference to the display of inattentiveness: 1. Participants receiving the dietary supplement combination were expected to display less inattentiveness than those receiving the placebo, based on parent and teacher reports.

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2. Participants receiving Ritalin plus the dietary supplement combination were expected to display less inattentiveness than those receiving Ritalin plus the placebo, based on parent and teacher reports. 7 The study proposed the following hypotheses for Trial I in reference to the display of hyperactivity-impulsivity: 3. Participants receiving the dietary supplement combination were expected to display less hyperactivity impulsivity than those receiving the placebo, based on parent and teacher reports. 4. Participants receiving Ritalin plus the dietary supplement combination were expected to display less hyperactivity-impulsivity than those receiving Ritalin plus the placebo, based on parent and teacher reports. Trial II Hypotheses The study proposed the following hypotheses for Trial II in reference to the display of inattentiveness: 1. Participants receiving the double dietary supplement combination with an essential fatty acid were expected to display less inattentiveness than those receiving the double dietary supplement combination, based on parent and teacher reports.

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2. Participants receiving Ritalin plus the double dietary supplement combination with an essential fatty acid were expected to display less inattentiveness than those receiving Ritalin plus the double dietary supplement combination, based on parent and teacher reports. 8 The study proposed the following hypotheses for Trial II in reference to the display of hyperactivity-impulsivity: 3. Participants receiving the double dietary supplement combination with an essential fatty acid were expected to display less hyperactivity-impulsivity than those receiving the double dietary supplement combination, based on parent and teacher reports. 4. Participants receiving Ritalin plus the double dietary supplement combination with an essential fatty acid were expected to display less hyperactivity-impulsivity than those receiving Ritalin plus the double dietary supplement combination, based on parent and teacher reports. Overview A review of relevant research and related literature on ADHD is presented in Chapter Two. A detailed description of the study's methodology is included in Chapter Three. Results of this study are presented in Chapter Four. A discussion of the results, study limitations, and

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recommendations for future research are included in Chapter Five. 9

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CHAPTER TWO REVIEW OF LITERATURE Historical Views The roots of ADHD can be traced back thousands of years. The ancient Greeks described the disorder's common features (i.e., inattentiveness and hyperactivity) (Husain & Cantwell, 1991). German physician Heinrich Hoffman described these ADHD characteristics in 1845 (Cantwell, 1975) Our present concept of ADHD has its foundation in the work of George Frederic Still and Alfred Tredgold (Sandberg & Barton, 1996). Still (1902) described an ADHD-type cluster of behaviors that included hyperactivity, inattention, and conduct disturbance in children. He attributed hyperactive behavior to a defect of moral control. This theory is supported by the proposal that suggests ADHD is a deficit in sensitivity to reinforcement (Haenlein & Caul, 1987) or rule-governed behavior (Barkley, 1981, 1989b). A theory of deficient attention, inhibition, and arousal, and preference for immediate reward also provides evidence for this claim 10

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11 (Douglas, 1972, 1983). Still's research parallels many of the facets of our current knowledge of ADHD, namely a heredity component of the disorder, and the possibility that ADHD occurs from acquired nervous system injury (Barkley, 1997a). Extreme defects observed in Still's sample of children were due more to biological factors than environmental factors. ADHD was thought to be caused by genetic transmission, central nervous system damage, or certain brain diseases or infection (Mellor, Storer, & Brown, 1996). Tredgold (1908) adopted the theory that damage, often mild and undetected, occurred in the early stages of an individual's development. Damage resulted in behavioral problems or hyperactivity. This belief gained support following the 1917-18 encephalitis epidemic when children began suffering from both behavioral and cognitive problems (Sandberg & Barton, 1996). Theoretical Views Several theories to explain ADHD have been postulated. One theory suggests a central deficiency in inhibitory processes is present in persons with ADHD (Schachar & Logan, 1990). This theory proposes that an event or stimulus is hypothesized to trigger an activating or primary response

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12 and an inhibitory response. As a result, there is competition between the two with reference to which will be executed first. Disinhibited children (e.g., those with ADHD) have a slower start of inhibitory processes compared to normal children (Schachar, Tannock, & Logan, 1993). Another theory conceptualizes persons with attention deficits as hunters in a farmer's world (Hartmann, 1997) That is, those with the disorder are "hunters," while those without it are "farmers." Individuals with attention deficits are considered leftover hunters whose ancestors evolved and matured thousands of years ago in hunting societies. Their characteristics (i.e., impulsivity, distraction, and even aggression) make them ideal for hunting. However, the criteria for this theory may have been developed from observations of individuals with ADHD rather than hunters, since some hunters never display the clinical symptoms of ADHD (Shelley-Tremblay & Rosen, 1996). A recent theory centers around the assumption that the impairment in ADHD is a deficit in response inhibition (Barkley, 1997b). Developmental failure in the circuitry underlying inhibition and self-control is believed to be the cause of ADHD (Barkley, 1998). The theory's model postulates a link between response inhibition and four executive

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13 neuropsychological functions: working memory, self regulation of affect-motivation-arousal, internalization 0 speech, and reconstitution (behavior analysis and synthesis), which depend on this inhibition for effective performance. Evidence suggests deficits in behavioral inhibition, working memory, and regulation of motivation are most prominent in persons with ADHD. Characteristics ADHD is a treatable but not curable complex disorder. Children and adolescents comprise the ages most predominantly affected. The disorder typically occurs in children between ages 3 and 7 (Loeber, Green, Lahey, Christ, & Frick, 1992), and is diagnosed using criteria established in the DSM-IV (American Psychiatric Association, 1994) The incidence of ADHD-related behaviors, while low in preschool and kindergarten, increases dramatically in first grade and remains fairly stable thereafter (Pellegrini & Horvat, 1995) Symptoms diminish by approximately 50 % every five years between the ages of 10 and 25 (Goldman et al ., 1998) Up to 50 % of children with ADHD display significant symptoms at age 25 (Mannuzza, Klein, Bonagura, Malloy, Giampino, & Addalli, 1991; Weiss, Milroy, & Perlman, 1985) and some believe the syndrome never disappears with maturity

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14 (Gittelman, Mannuzza, Shenker, & Bonagura, 1985; Gross, 1997; Hechtman, 1992; Klein & Mannuzza, 1991; Weiss et al., 1985). ADHD usually is characterized by serious and persistent difficulties resulting in inattention, hyperactivity, and impulsivity (American Psychiatric Association, 1994). Inattention Inattention comprises a main characteristic of children with ADHD. Teachers often note these children do not listen as well as they should, cannot concentrate, daydream, and change activities more than others. Inattention is a multi dimensional construct referring to problems with alertness, arousal, selectivity, sustained attention, and distractibility (Hale & Lewis, 1979). Inattention is seen most often in activities requiring children to sustain attention to dull, boring, repetitive tasks (e.g., schoolwork, homework, chores) (Luk, 1985; Milich, Loney, & Landau, 1982; Ullman, Barkley, & Brown, 1978). Inattention also is seen in children who are more disorganized, forgetful, and distracted than their peers. Hyperactivity Hyperactivity typically is the most visible and observable characteristic of children with ADHD. Hyperactive

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15 children often fidget, are noisy, and engage in nervous habits (e.g. finger tapping, hair twirling). They become easily over-excited and loud when externally over stimulated. They frequently change activities without fully completing them. Many children exhibit hyperactive symptoms, but it is the frequency, duration, and intensity with which they occur that determine a diagnosis of ADHD Impulsivity Children with ADHD act impulsively, showing little regard for the consequences of their actions. Students encounter trouble because they make decisions and act too quickly without allowing sufficient time between presentation of the stimulus and their response (Lerner, Lowenthal, & Lerner, 1995). Displays of impulsivity in school--shouting out remarks without waiting for their turn, answering questions before hearing or reading the entire problem, or interrupting others--can lead to deficient academic attainment and inadequate social relationships. Prevalence ADHD is the most common chronic behavioral disorder in children (Johnson, 1997). It is not limited to one particular group. Children who are gifted and talented also

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may exhibit symptoms of ADHD. The disorder also occurs across cultures and ethnic groups. 16 The prevalence of ADHD, the proportion of the population affected, is estimated between 6 and 8 % of school-aged children (Baren, 1995). Depending on the criteria used for diagnosis, the prevalence rate may be as high as 10 % (Tan & Schneider, 1997). Disagreement about the prevalence of ADHD is due, in part, to lack of agreement among professionals as to which neurological dysfunctions characterize the syndrome (Gross, 1997). The disorder is more common in boys. The male-female ratio ranges from 2:1 to 10:1 (Szatmari, Offord, & Boyle 1989). The greater frequency with which it occurs in males may be attributed to the fact that boys are far more likely than girls to be referred for evaluation, especially if they display oppositional or conduct disorders (Barkley 1996 ; Swanson, Sergeant, Taylor, Sonuga-Barke, Jensen, & Cantwell 1998). Although boys evidence more neuropsychological disorders, gender differences and neuropsychological performance of children with ADHD remain largely unexamined (Arcia & Conners, 1998)

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17 Girls with ADHD may be more likely to go undetected (Berry, Shaywitz, & Shaywitz, 1985; Hinshaw, 1994; Szatmari et al., 1989). Since girls are less aggressive, they are more likely to mask symptoms of ADHD (Bain, 1991; Buncher, 1996). More females are likely to be diagnosed as "predominantly inattentive" following the publication of the DSM-IV (Boliek & Obrzut, 1997). Incidence ADHD affects approximately 2 to 3 million school-aged children in the United States (Ricchini, 1997). Every classroom from kindergarten through 12th grade in the U.S. on average has one of two students who has been diagnosed with the disorder (Schneider & Tan, 1997). While some claim ADHD is over-diagnosed, research suggests this may not be the case (Goldman et al., 1998). Researchers found that although some children are being diagnosed with ADHD without a sufficient evaluation, there is little evidence of widespread over-diagnosis of the disorder. The number of children identified with ADHD recently has increased dramatically. It is difficult to determine whether the increase in the prevalence of ADHD is the result of clearer clinical diagnosis or better recognition of the disorder over the past four decades (Scahill & deGraft

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18 Johnson, 1997). Increases also may be attributed to different methods for selecting subjects for research studies (Barkley, 1996), the key symptoms emphasized (Sherman, McGue, & Iacono, 1997), who reports the occurrence of behaviors (Sherman et al., 1997), and age ranges of samples (Barkley, 1996). Etiology The study of the causes of hyperactivity has occurred in distinct periods (Williams & Cram, 1978). Before World War II, hyperactive behaviors were believed to be related to brain damage. From World War II to 1960, attention was placed on the symptomatology of minimal brain dysfunction. Severely overactive and disruptive children were believed to have a central nervous system deficit in the thalamic area of their brain, resulting in cortical overstimulation. Since 1960, deficits in sustained attention and impulse control have been considered more likely to account for hyperactivity. The etiology of ADHD remains unclear. Precipitating factors often are unknown and the cause typically is considered idiopathic (Boris & Mandel, 1994). Symptoms of ADHD may result from a variety of causal mechanisms, such as preand postnatal factors, neurological variables,

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neurochemicals, genetics, diet, candidiasis, temperament, and lead exposure. Preand Post-natal Factors Prenatal factors can put a fetus at risk. Absence of prenatal care, inadequate maternal nutrition, infections, stress, and metabolic or toxic factors may impact a developing fetus. Anepartum hemorrhage and length of labor have been associated with ADHD (Chandola, Rohling, Peters, Melville-Thomas, & McGuffin, 1992). Prenatal exposure to alcohol and tobacco smoke is related to inattention and hyperactivity (Bennett, Wolin, & Reiss, 1988; Milberger, Biederman, Faraone, & Jones, 1998; Nichols & Chen, 1981; Shaywitz, Cohen, & Shaywitz, 1980; Streissguth, Martin, Barr, Sandman, Kirchner, & Darby, 1984), and children born with fetal alcohol syndrome were found to exhibit symptoms of hyperactivity, impulsivity, and inattention (Frederick, 1998). 19 Acquired medical problems and extensive post-natal trauma to the nervous system can result in ADHD or ADHD-like behaviors (Silver, 1992). An association between otitis media in infancy and later development of ADHD has been discovered (Adesman, Altshuler, Lipkin, & Walco, 1990; Weintraub, 1997). Effects of viral encephalitis can include

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hyperactivity, distractibility, and impulsivity (Tredgold, 1908). Children and adolescents with a history of a closed head injury also may display these behaviors. Neurological Variables A neurological basis of ADHD has been suggested (Rosenberger, 1991). The early onset and persistent nature of ADHD support this neurological origin. The belief that dysfunction in the brain or central nervous system causes ADHD has been held for almost a century (Lerner et al., 1995). Frontal lobe underactivity is associated with ADHD (Chelune, Ferguson, & Richard, 1986; Lou, Henriksen, & Bruhn, 1984). Findings of deficient performance on 20 neuropsychological tests associated with prefrontal lobe functions (e.g., inhibition, persistence, working memory) further support a neurological basis (Barkley, 1990; Barkley, Grodzinsky, & DuPaul, 1992; Goodyear & Hynd, 1992). Brain damage The purpose of the brain is to control movement, sleep, hunger, thirst, and nearly every other vital activity necessary for survival. It also receives and interprets countless signals sent to it from other parts of the body and from the external environment. Thus, proper functioning of the brain is critical.

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21 The first neurological theory hypothesized children with ADHD had structural brain damage that contributed to their attention and behavior difficulties (Anastopoulos & Barkley, 1988). Current evidence suggests most children with ADHD do not have structural defects in the central nervous system. Thus, structural brain damage is no longer considered a primary cause of ADHD (Barkley, 1990). Reticular activating system The lower portion of the brain contains the Reticular Activating System (RAS), the attention center in the brain. The purpose of the RAS is to regulate the level of alertness and arousal and filter out irrelevant distractors in the environment. When functioning properly, the RAS provides the neural connections needed to attend to a task. If the RAS does not excite the neurons of the cortex as much as it should, underarousal results in a lack of self-control, poor memory, and learning difficulties. An excited RAS leads to an overarousal of the cortex and other brain systems. This can cause an individual to talk too much, become restless, and act hyperactive. A dysfunction in the RAS has been proposed as a neurological basis for ADHD (Nussbaum & Bigler, 1990).

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22 Neurochemicals The purpose of neurotransmitters is to facilitate communication among cells. An imbalance or deficiency in certain neurotransmitters has been studied as an etiological variable (Raskin, Shaywitz, Shaywitz, Anderson, & Cohen, 1981). Children with ADHD are believed to possess an insufficient amount of necessary chemicals in their brains (Friedman & Doyal, 1992; Goldstein & Goldstein, 1990). Studies of monoamines have received the most attention as a possible cause of ADHD (Kado & Takagi, 1996; Silver, 1992) Monoamines are comprised of the catecholamines (e.g., dopamine and norepinephrine) and the indoleamines (e.g., serotonin). Metabolic studies have shown that glucose (Zametkin, Nordahl, Gross, King, Semple, Rumsey, Hamburger, & Cohen, 1990), norepinephrine (Shekim, Javaid, Davis, & Bylund, 1983; Shekim, Javaid, Dekirmenjian, Chapel, & Davis, 1982), dopamine (Shaywitz, Yager, & Klopper, 1976), adrenaline (Weintraub, 1997), and thyroid dysfunction (Hauser, Zametkin, Martinez, Vitiello, Matochik, Mixson, & Weintraub, 1993) are related to ADHD. Dopamine and norepinephrine are the two most important chemicals in the attentional system (Goldstein & Goldstein, 1990). These neurotransmitters affect the regulation of

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attention, inhibition, and motor responses. They are presumed to be deficient in certain regions of the brain, thus contributing to symptoms of ADHD (DuPaul & Stoner, 1994) 23 Research on cerebral glucose metabolism has provided strong evidence of a biological basis for ADHD (Zametkin et al., 1990). Glucose promotes human cell development. Rates of metabolism are significantly slower in those with ADHD. Researchers also discovered a relationship between the areas of the brain affected and the nature of the symptoms of hyperactivity in adults. Genetic Influence Some have postulated a genetic contribution to ADHD (Cantwell, 1972; Hechtman, 1993; Fouse & Brians, 1993; Rutter, Macdonald, LeCoutier, Harrington, Bolton, & Bailey, 1990; Sherman, Iacono, & McGue, 1997; Stevenson, 1992). The discovery of an association with a single dopamine transporter gene (Cook, Stein, Krasowski, Cox, Olkon, Kieffer, & Leventhal, 1995) and a variation in the D4 dopamine receptor gene (LaHoste, Swanson, Wigal, Glabe, Wigal, King, & Kennedy, 1996; Swanson, Sunohara, Kennedy, Regino, Fineberg, Wigal, Lerner, Williams, LaHoste, & Wigal, 1998) has increased the interest in a genetic basis. Genetic

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studies may provide evidence for an underlying genetic relationships between clinical phenotypes, thus leading to biologically based understanding of the diagnosis and treatment of ADHD (Levy, Barr, & Sunohara, 1998). Family studies 24 Results of behavioral genetic studies have provided additional evidence supporting a hereditary contribution (DuPaul & Stoner, 1994; Faraone, Biederman, Keenan, & Tsuang, 1991 ; Gross-Tsur Shalev, & Amir, 1991). Immediate family members of children with ADHD have a higher rate of concurrent and past ADHD symptoms than their non-ADHD counterparts (Anastopoulos & Barkley, 1988) Up to 20 % of mothers (Silver 1992), up to 30 % of fathers (Silver, 1992), and up to 35 % of biological siblings (Biederman, Faraone, et al 1991; Biederman, Faraone, & Lapey, 1992; Pauls, 1991 ; Silver, 1992 ; Welner, Welner Stewart, Palkes, & Wish 1977) of children with ADHD have the disorder Second-degree relatives also display a higher incidence of ADHD (Faraone, Biederman, & Milberger, 1994). However, it often is difficult to accurately identify the contributing effects of genetics and environment, inasmuch as the two co-occur.

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25 Twin studies Monozygotic twins display higher rates of ADHD when compared to dizygotic twins (Cunningham & Barkley, 1978; Heffron, Martin, & Welsh, 1984; Lopez, 1965; Sherman, McGue, et al 1997). There is a high concordance for hyperactivity and inattention in monozygotic pairs (51 to 100%) and dizygotic pairs (17 to 33%) (Gillis, Gilger, Pennington, & DeFries, 1992; Goodman & Stevenson, 1989; O'Connor, Foch, Sherry, & Plomin, 1980; Willerman, 1973). Adoption studies The adoption study method is regarded as one of the most powerful tools for studying complex human behavioral disorders (DeFries & Plomin, 1978). Studies of adopted children with hyperactivity report higher rates of hyperactivity in the biological parents than in the adoptive parents (Alberts-Corush, Firestone, & Goodman, 1986; Cantwell, 1975; Morrison & Stewart, 1971, 1973). A strong genetic component also has been shown for attention problems among biologically-related adoptees (van den Oord, Boomsma, & Verhulst, 1994). Diet Factors The role of diet in behavior has been investigated for many years. Early research suggested that behavior and

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learning can be affected by diet (Shannon, 1922). In a majority of studies a significant change in behavior was noted with d i etary intervention (Breakey, 1997). Certain foods have been shown to alter brain electrical activity (Uhlig, Merkenschlager, Brandmaier, & Egger, 1997), and children on an elimination diet exhibited normalization in previous EEG abnormalities (Kittler & Baldwin, 1970) In addition, food allergies and sensitivities and food additives have been cited as affecting behavior. Food allergies 26 Reports since the 1920s have linked hyperactive behavior with food allergies (Crook, 1997; Ross & Ross 1976). Food allergies may be related to the onset or exacerbation of ADHD. It has been suggested that two-thirds of children with ADHD would not need pharmaceutical intervention if their food allergies were detected and treated (Rapp 1998). Symptoms of irritability, fatigue, and behavior problems have been attributed to an allergic response to foods (Randolph, 1947) Food allergies may have a cumulative effect, causing a child with a weak sensitivity to certain foods to become hyperactive if a large amount of these foods are consumed within a short period of time (Conners, 1980b). The

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27 relationship between food allergies and hyperactivity is strongest in hyperactive children who also exhibit evidence of learning disabilities and minimal brain dysfunction concurrently (Trites, Tryphonas, & Ferguson, 1980). However, empirical data do not support the claim that food allergies play a role in ADHD (Palmer, Rapoport, & Quinn, 1975; Trites et al., 1980; Tryphonas & Trites, 1979; Varley, 1984). Food sensitivities Response to food dyes and additives is considered a sensitivity, not an allergy, since the primary symptoms are behavioral disturbances (e.g., short attention span, nervousness) rather than physical disturbances (e.g., hives, respiratory problems (Swanson & Kinsbourne, 1980a). Sensitivities to food dyes have been reported since 1940 (Weintraub, 1997). Clinical cases of hypersensitivity are noted with dyes commonly ingested from foods and medicines (Lockey, 1971, 1977). This sensitivity may lead to an intolerance of different foods, resulting in hyperactivity, aggression, mood swings, and rebellion (Jordan, 1998). Food dyes, additives, and natural salicylates are implicated as a cause of ADHD (Feingold, 1973a, 1975a, 1975b). A relationship was first noted when a patient's hostile and aggressive behavior ceased following a diet that

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excluded artificial colors and flavors (Harley & Matthews, 1980) Sensitivity to artificial colors is caused by a pharmacological response, similar to a sensitivity to aspirin (Feingold, 1975a, 1975b). 28 Thirty-four synthetic food colors, 1,610 synthetic flavors, and 1,120 other chemicals (e.g., preservatives) added to foods are believed to cause hyperactivity once ingested (Feingold, 1973b). Natural salicylates also have been targeted in the belief that they cross-react with additives (Swanson & Kinsbourne, 1980a) The increased incidence of hyperactivity is related to an increase in consumption of food colorings, flavorings, and preservatives (Feingold, 1975a, 1975b) Removal of the substances reportedly terminates the hyperactive symptoms Evidence suggests that children affected by food dyes and additives differ biochemically from those who remain unaffected (Brenner, 1979) Some researchers believe children are born with a genetic predisposition for hyperactivity that is triggered by these substances For example Erythrosin B (i.e., Red No. 3) often is used in candies powdered desserts, and beverages Concentrations of this dye partially prevents brain cells from taking in dopamine (Augustine & Levitan, 1980; Lafferman & Silbergeld,

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1979). The blocking of dopa.mine by the food dye is consistent with the theory that the dye can cause hyperactivity in some children. Candidiasis 29 Symptoms of ADHD have been attributed to Candida albicans, a common yeast in the human body (Bell & Peiper, 1997; Crook, 1983, 1997). Candidiasis, an overgrowth of this yeast, causes a release of toxins in the intestines that results in hyperactivity, irritability, anxiety, and other symptoms (Rapp, 1991) Yeast interferes with the formation of fatty acid conversions and can overwhelm and damage the immune system, especially when using antibiotics. Antibiotics increase the growth of yeast, which in turn increase the absorption of food antigens putting a child at risk for food sensitivities. This may play an important role in causing ADHD and other behavior and learning problems (Weintraub, 1997). Temperament Children s temperament may contribute to their ADHD symptoms (Friedman & Doyal, 1992). Studies of temperament in hyperactive children indicate its importance in the development of hyperactivity (Prior & Griffin, 1985). Temperament patterns differ for hyperactive and control

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30 subjects (Dudding & Dudding, 1995; Lambert, 1982). Children with hyperactivity are characterized by low adaptability, low persistence, high activity, and high negativism (Carey & McDevitt, 1980). An effort must be made to determine whether hyperactivity is a reflection of ADHD, an expression of temperament characteristics, or a combination of the two (Friedman & Doyal, 1992). Temperament was only one of three factors to contribute to hyperactivity (i.e., preand peri-natal factors, family, and home environmental characteristics). Its contribution has been found to be more significant than the others (Lambert, 1982; Lambert & Hartsough, 1984). Differences in temperament between hyperactive and non-hyperactive children of the same age, gender, and social class are noted for children as young as preschoolers (Prior, Leonard, & Wood, 1983) The diagnosis of ADHD among school children may be attributed to personality type (Provost, 1994), and its diagnosis may be related to an insufficient appreciation of normal temperament variations (Carey, 1998). Type preferences of teachers and parents predisposes them to conflict with children who manifest ADHD symptoms (Johnson, 1995). For example, introverted parents or teachers may view

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children with an extroverted personality as more likely to possess the disorder. Lead Exposure 31 Exposure to lead is one the nation's most serious environmental threat to children's health. Factory exhaust, urban topsoil, water pipes, metal food containers, fruits and vegetables, and paint may contain high levels of lead. Many of the children affected are from economically impoverished families. In the United States, half a million children on Medicaid ages five years and under have harmful levels of lead in their blood ("Lead Screening," 1998). The neurotoxic effects of lead affects brain function and is associated with a number of neurological and psychological disorders, including ADHD (Baloh, Sturm, Green, & Gleser, 1975; David, 1974; de la Burde & Choate, 1972, 1974; Walker, 1996; Weintraub, 1997). Exposure to lead is linked to disruptive behavior, distractibility, impulsivity, poor school performance, and low IQ (Fergusson & Horwood, 1993; Fergusson, Horwood, & Lynskey, 1993; Needleman, Schell, Bellinger, Leviton, & Allrich, 1990; Thomson, Raab, Hepburn, Hunter, Fulton, & Laxen, 1989; Yule, Lansdown, Millar, & Urbanowicz, 1981). Lead poisoning also has been shown to be associated with ADHD (David, Clark, &

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32 Voeller, 1972; Rummo, Routh, Rummo, & Brown, 1979). Treatment to reduce the levels of body lead has accounted for behavioral improvements in hyperactive children (David, Hoffman, Sverd, Clark, & Voeller, 1976; Eppright, Sanfacon, & Horwitz, 1996). Diagnosis A diagnosis of ADHD requires a comprehensive and detailed evaluation. Diagnosing hyperactivity and impulsivity remains subjective, despite sophisticated assessment techniques (Johnson, 1997). A diagnosis comes from a number of sources, based on an evaluation of the intensity and duration of symptoms (Buncher, 1996). An appropriate assessment includes a medical, behavioral, and educational history, evidence of normal vision and hearing, recognition of systemic illness, and a developmental survey (National Attention Deficit Disorder Association, 1998). ADHD is diagnosed exclusively on the basis of observable behavior patterns, since it is difficult to determine specific biochemical or neuropsychological tests that contribute to a more accurate diagnosis (Kuperman, Johnson, Arndt, Lindgren, & Wolraich, 1996). The delineation from normals is partially determined by local cultural factors

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33 since no biological markers for general use exist (Lou, 1996) Specifying symptoms to ADHD has not been demonstrated (Halperin, Matier, Bedi, Sharma, & Newcorn, 1992). Confounding diagnosis is the problem of other conditions sharing similar symptoms (Buncher, 1996). These include processing disorders (e.g., language disorders), medical disorders (e.g., hyperthyroidism, infections, seizure disorders), chromosomal or genetic abnormalities (e.g., Turner's syndrome, Tourette's syndrome, sickle-cell anemia), emotional disorders (e.g., depression, anxiety, manic depression), and environmental factors (e.g., dysfunctional family dynamics, abusive home situations, school placement). Studies attempting to distinguish children with ADHD from other patient groups, based on measures of attention, have yielded negative results (Koriath, Gualtieri, Van Bourgondien, Quade, & Werry, 1985; Shapiro & Garfinkel, 1986; Werry, Elkind, & Reeves, 1987). Although behaviors from these disorders may be similar to ADHD, their causes and treatments are different. DSM-IV Criteria The main feature of ADHD, as outlined in the DSM-IV, is a persistent pattern of inattention or hyperactivity

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34 impulsivity that occurs more frequently and severely than in a child's same-age peers. The symptom pattern must have appeared before age 7 years and the impairment must be observed in at least two settings (e.g., school and home) Children with ADHD differ from their peers only in the intensity, persistence, and clustering of symptoms (Lin Dyken & Wolraich, 1992). The diagnostic criteria of ADHD are empirically-based. They were derived from leading experts, literature reviews, an informal survey of rating scales assessing the behavioral dimensions related to ADHD, and statistical analyses from a field trial of items (Barkley, 1996). The DSM-IV outlines distinct subtypes of ADHD to help aid in the diagnosis of the disorder. These subtypes are: predominantly inattentive type, predominantly hyperactive-impulsive type, and combined type. Predominantly inattentive type (ADHD-PI) Specific symptoms of inattention, hyperactivity, or impulsivity must be displayed in academic, social, or occupational situations. In their schoolwork, children with ADHD may demonstrate characteristics of inattention by not paying attention to details and making careless mistakes. They find it difficult to persist with tasks, act as if they

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35 are not listening, shift from one uncompleted task to the next, and fail to complete their assignments, even if instructions were understood (Boliek & Obrzut, 1997). Homework assignments are avoided because they require sustained attention and organization. Six of nine inattention characteristics from the DSM-IV must be present and considered deviant. Predominantly hyperactive-impulsive type (ADHD-PHI) Children who are hyperactive can be viewed as having excessive amounts of locomotion, such as excessive movement in their seat, running or climbing at inappropriate times, talking indiscriminately, or poor control of motor system. Toddlers and preschoolers display the same behaviors, although less frequent and less intense. Adolescents and adults may feel restless and find it difficult to participate in sedentary activities Children described as impulsive lack patience and find it difficult to delay responses to their external environment. They may make comments out of turn or at inappropriate times. Children with ADHD often interrupt others, do not wait for instructions or directions, and touch objects off-limits. Six of nine hyperactivity impulsivity characteristics from the DSM-IV must be present

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36 and considered deviant. It is unclear whether children in the ADHD-PHI category are separate from the ADHD-C (i.e., combined type) category or in an earlier developmental stage of it (Barkley, 1996). Combined type (ADHD-C) The combined type is used if six or more symptoms of hyperactivity-impulsivity, but fewer than six symptoms of inattention, have persisted for the previous six-month period. Children may have one subtype of the disorder at one period of time and may develop another predominant subtype at a later date. If specific criteria are no longer met for the three subtypes, the diagnosis made is attention deficit/hyperactivity disorder, in partial remission. Increased Diagnosis Two federal government programs have been identified as possibly increasing the diagnosis of ADHD (Merline, 1997). In 1990, the federal Supplemental Security Income program was created to provide money, as much as $560 per month for each child, to low-income parents of children diagnosed with ADHD. Special education grant money became available in 1991, with $400 in grant money being awarded to schools for each student diagnosed with the disorder. The diagnosis of ADHD was level prior to the inception of these two programs

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37 but has increased 21% each year since (Merline, 1997) Other factors also that may contribute to an increase in a diagnosis include: increased public and physician awareness and acceptance of the condition, acceptance of a broader case definition, greater knowledge of the illness course, fewer interruptions in treatment because of diminished concerns regarding growth retardation, and increased treatment of adults (Goldman et al., 1998). Misdiagnosis Misdiagnosis of ADHD is a potential problem In one study, about half of the children at one military hospital did not meet the standards in the DSM-IV, although all were being given medication for their symptoms (Debroitner & Hart, 1997). Misdiagnosis may occur because the symptoms of ADHD are shared with other disorders Therefore, it is important that a comprehensive medical evaluation be conducted before treatment begins. Assessment School-based evaluation of ADHD is conducted in five stages (Figure 1) (DuPaul & Stoner, 1994). The stages are based upon an educational decision-making model. These five stages include: screening, multimethod assessment,

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Teacher Complaint of Inattention, Impulsivity, and/or Overactivity Stage 1: Screening Teacher Ratings of ADHD Symptoms il Stage 2: Multimethod Assessment of ADHD Parent and Teacher Interviews Reviews of School Records Behavior Rating Scales Observations of School Behavior Academic Performance Data il Stage 3: Interpretation of Results Number of ADHD Symptoms Deviance from Age and Gender Norms Age of Onset and Chronicity Pervasiveness Across Situations Degree of Functional Impairment Rule-out Other Disorders il Stage 4: Develop Treatment Plan, Based Upon: Severity of ADHD Symptoms Functional Analysis of Behavior Presence of Associated Disorders Response to Prior Treatment Community-based Resources il Stage 5: Assessment of Treatment Plan Periodic Collection of Assessment Data Revision of Treatment Plan Figure 1. Five Stages of School-based Assessment of ADHD (adapted from DuPaul & Stoner, 1994). 38

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39 interpretation of results, development of a treatment plan, and assessment of the treatment plan. The first stage includes the determination of whether a student has problems related to ADHD. If so, a decision is made in reference to the need for further assessment. A teacher interview will help to specify the behavioral concerns and to identify environmental factors that may contribute to problem behavior. The interview will provide information on the frequency, intensity, and duration of these behaviors, and whether environmental factors (e g., method of instruction transition) act as an antecedent or consequent event for behavior. Teacher ratings of ADHD symptoms also are obtained. Multiple assessment techniques are utilized during the second stage. Parent and teacher interviews are conducted to specify behaviors and the factors maintaining them They also will complete questionnaires to provide information regarding the frequency and severity of behaviors. School records and academic performance data are reviewed to provide historical and current data. Direct observation of the child across settings can provide further evidence of the frequency and duration of target behaviors.

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40 Assessment results are interpreted during the third stage. The goal is to obtain a consistent picture of the frequency and severity of ADHD behaviors across settings including possible causes. A child's behavior is evaluated using DSM-IV criteria. Both parents and teachers provide information about the number of symptoms, deviance from age and gender norms, age and onset of chronicity, pervasiveness across situations, and degree of functional impairment. Other causes (e.g., poor or inconsistent instruction or behavior management) are ruled out before a diagnostic decision is reached. A treatment plan is developed during the fourth stage. Interventions are designed to target behaviors across academic and social domains. The severity of a child s symptoms must be considered, as more severe symptoms increase the likelihood the child will be referred to a physician. The presence of additional behavior or learning disorders must be considered when developing treatment strategies, and these strategies are contingent upon the child's response to previous interventions. The availability of treatment resources must be considered. This will decide whether the child is referred to a community-based professional (e g., child psychologist) or whether home

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41 based interventions designed by the school psychologist are implemented. An assessment of treatment is conducted during the fifth stage. The student acts as his or her own control, and behavioral change is evaluated in comparison to nonintervention conditions. Assessment data are repeatedly acquired across settings at different points in the intervention program. If reliable behavior change occurs, it can be assumed that the intervention was successful. If no change occurs, the intervention, or the way it is implemented, must be changed. Thus, ongoing assessment is very important. Assessment Techniques Over half of all children with ADHD are diagnosed in their elementary school years {Quinn, 1997). Consequently, with the exception of parents, teachers often are the first persons to observe the characteristics of ADHD. Children with ADHD are more inattentive, overactive, and impulsive than normal children. Measures of these constructs include observational procedures (Abikoff, Gittelman-Klein, & Klein, 1977; Atkins, Pelham, & Licht, 1985; Milich et al., 1982), behavior rating scales (Conners, 1969; McGee, Williams, & Silva, 1984), psychometric tests (Campbell, Douglas, &

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42 Morgenstern, 1971), and continuous performance tests (Klee & Garfinkel, 1983; Sykes, Douglas, Weiss, & Minde, 1971). Observational procedures A behavioral observation assessment approach typically is used to evaluate ADHD Multiple methods of data collection are employed with different observers across different settings (DuPaul & Stoner, 1994). Emphasis is placed on obtaining reliable information about a child's behavior from parents and teachers. The evaluation should include interviews with the child's parents and teachers, questionnaires completed by parents and teachers, and observations on the child's behavior in different settings. Behavior rating scales Behavior rating scales completed by parents and teachers provide important details about the severity of a child's symptoms. From this information we are able to determine the degree to which a child's characteristics are also exhibited by his or her peers. Rating scales collapse information across situations and time, thus providing information from persons who live and work with a particular child (Landau & Burcham, 1995). Caution must be used since behavior rating scales may measure teacher and parent tolerance or intolerance of

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43 children instead of the child's disability (Patterson, 1996). They also represent only opinions others have of the child rather than the child's strengths and uniqueness Landau & Burcham, 1995). However, a diagnosis of ADHD should never be made based solely on rating scales (National Attention Deficit Disorder Association, 1998). Examples of behavior rating scales include: ADD-H: Comprehensive Teacher Rating Scale (Ullman, Sleator, & Sprague, 1991), ADHD Rating Scale (DuPaul, 1991), Attention-Deficit/Hyperactivity Disorder Test (Gilliam, 1995), Attention Deficit Disorders Evaluation Scale (Mccarney, 1995a), Behavioral Assessment System for Children (Reynolds & Kamphaus, 1992), Child Behavior Checklist (Achenbach, 1991a), Comprehensive Behavior Rating Scale for Children (Neeper, Lahey, & Frick, 1990), Conners' Rating Scales-Revised (Conners, 1997a), Early Childhood Attention Deficit Disorder Evaluation Scales (Mccarney, 1995b), Teacher's Report Form (Achenbach, 1991b), and Youth Self-Report (Achenbach, 1991c). Rating scales used to assess comorbid symptoms and disorders include: Beck Depression Inventory-II (Beck, Steer, & Brown, 1996), Children's Depression Inventory (Kovacs, 1980/81), Revised Behavior Problem Checklist (Quay & Peterson, 1987), and Social Skills Rating System (Gresham & Elliott, 1990).

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44 Psychometric tests Results from cognitive, neuropsychological, and educational tests usually are not helpful in assessing a child for ADHD (DuPaul & Stoner, 1994). No individually administered test or group of tests has an acceptable level of validity (Barkley, 1991). Children often display appropriate behavior and attention when task conditions are highly structured and include one-on-one interaction, typically found with these testing situations (Barkley, 1990). Continuous performance test Standard measures of sustained attention and impulse control often are included in an evaluation. Frequently used standardized measures include the Conners' Continuous Performance Test (Conners, 1994), Gordon Diagnostic System (Gordon, 1986a), and Test of Variables of Attention (Greenberg, 1993). They provide data that are less influenced by factors that may bias parent and teacher reports (Barkley, 1987; Gordon, 1986b). Problems Associated with ADHD Symptoms Taken as a group of symptoms, ADHD may lead to complex or secondary difficulties (Green & Chee, 1994). A child often becomes the center of family and classroom problems.

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These problems include insatiability (e.g., nags and never lets a matter drop), social clumsiness (e.g., misreads social cues), poor coordination (e.g., poor flow of movement), disorganization (e.g., blind to mess), and variability (e.g., mood swings). 45 Symptoms of ADHD can have a profound effect on a child. They often lead to disturbed peer relationships (King & Young, 1982; Pelham & Bender, 1982; Scahill & deGraft Johnson, 1997), negative interactions with teachers (Whalen, Henker, & Dotemoto, 1980), and low self-esteem (Mellor et al., 1996; Ricchini, 1997; Safer & Allen, 1976; Weiss, Hechtman, & Perlman, 1978). Children with ADHD display these social difficulties very soon after entering the primary grades (Pellegrini & Horvat, 1995). As many as 65% of children with ADHD have at least one comorbid condition (Biederman, Newcorn, & Sprich, 1991). They have higher than expected rates of conduct disorder (Loney & Milich, 1982; Szatmari et al., 1989), affective disorders (Biederman, Faraone, Keenan, Benjamin, Krifcher, Moore, Sprich-Buckminster, Ugaglia, Jellinek, & Steingard, 1992), and tic disorders (Comings & Comings, 1984; DuPaul, & Stoner, 1994; Gadow, Nolan, & Sprafkin, 1995; Pauls, Leckman, & Cohen, 1993).

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46 Academic Achievement Children with ADHD are academic underachievers compared to their peers (Barkley, 1990; Barkley, DuPaul, & McMurray, 1990; Scahill & deGraft-Johnson, 1997). As many as 80 to 90% of children with ADHD exhibit some type of underachievement (Cantwell & Baker, 1991; McEwan, 1998). They demonstrate significantly lower rates of on-task behavior during work than that of their classmates (Abikoff et al., 1977). The cumulative effects of inattention can result in a drop of 7 to 15 IQ points (McEwan, 1998). Additionally, between 30 and 60% of children with ADHD also have learning disabilities or language problems (Nemethy, 1997), the most common type being dyslexia (Jordan, 1998). These children are considered learning disabled because of deficits in the acquisition of specific academic skills (DuPaul & Stoner, 1994). Peer Relationships It is difficult for children with ADHD to initiate and maintain friendships with their classmates. Approximately half may experience trouble making and keeping friends (McEwan, 1995). They engage in more aggressive interactions (Pelham & Bender, 1982), disruptions and interference in group play (Prior & Griffin, 1985), and display more

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controlling and dominating behaviors with their peers (Cunningham, Siegel, & Offord, 1985) when compared with normal children. In general, their peer interactions are intrusive and often negative (Barkley, 1990). 47 A high rate of peer rejection exists for children displaying ADHD-related behaviors (Milich & Landau, 1982; Pelham & Bender, 1982). For example, they may encounter trouble playing group sports if they ignore rules, do not follow instructions, and possess possible visual-motor or gross motor difficulties. About half of all children with ADHD have poor motor coordination (Nemethy, 1997). As many as 60% experience some form of social rejection from their peers (Guevremont, 1990). Peer rejection is stable over time, providing evidence of the chronic nature of interactional difficulties (Parker & Asher, 1987). Approximately 45% remain rejected one year later, and as many as 30% maintain their rejected social status for up to four years (Guevremont, 1990). Self-esteem Low self-esteem frequently is reported by children with ADHD. Self-esteem is particularly at risk at the elementary school age, and children display low self-esteem as early as the first or second grade (Campbell, Schleifer, Weiss, &

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48 Periman, 1977). Low self-esteem can occur since children with ADHD may not perform as well as their peers academically (Barkley, 1990). In addition, self-esteem of older children may be damaged when they realize their chance for entering certain occupations (e.g., military) is reduced because of prior use of stimulant medications (Johnson, 1998; "Ritalin Use," 1996). However, important short-term gains from the medication may help to preserve the self esteem in some children with ADHD, and their parents, teachers, and peers (Reichenberg-Ullman & Ullman, 1996). Conduct Disorder The presence of ADHD may trigger an early onset of conduct disorder symptomatology (Hinshaw, Lahey, & Hart, 1993). As many as 50% of children with ADHD will display enough signs of antisocial behavior to receive a diagnosis of conduct disorder (Barkley, 1990; Klein & Mannuzza, 1991). Lying, stealing, and truancy are the behaviors most commonly occurring with conduct problems. Adolescents with ADHD engage in activities that result in more school suspensions, and have more adversarial relationships with police compared to adolescents without the disorder (Goldstein, 1997). The overlapping subgroup of children with both conduct disorder and ADHD display a more destructive form of psychopathology

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49 than does either single-diagnosis category (Hinshaw & Anderson, 1996) They display more physical aggression and a greater range and greater persistence of antisocial behavior. Parent and teacher ratings of the symptoms of conduct disorder correlate highly with each other (Hinshaw, 1987) Affective Disorders Disagreement exists with regard to the comorbidity of affective or mood disorders with ADHD (Hinshaw, 1994). As many as 20% of children have anxiety or mood disorders (Goldman et al., 1998). Overlap has been found to occur in community and clinic samples (Anderson, Williams, McGee, & Silva, 1987; Biederman, Faraone, et al., 1991). Overlap rates range from chance levels to over 70% in various studies (Biederman, Newcorn, et al., 1991). Yet, other studies have concluded that children with ADHD are not at an increased risk for mood disorders (Gittelman et al., 1985; Lahey, Pelham, Schaughency, Atkins, Murphy, Hynd, Russo, Hartdagen, & Lorys-Vernon, 1988). Depression Children diagnosed with ADHD may actually be suffering from depression (Block, 1996; Bloomfield & McWilliams, 1994). Chronic monopolar depression often is hidden by ADHD

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(Jordan, 1998). As many as 75% of children with ADHD may also suffer from depression (Armstrong, 1995). 50 A familial link between ADHD and depression has been proposed (Faraone & Biederman, 1998). Adopted children with ADHD have high rates of depression in their biological relatives (Deutsch, Swanson, Bruell, Cantwell, Weinberg, & Baren, 1982). Familial risk analyses suggest major depression and ADHD may represent a variable expression of the same etiological factors that cause ADHD (Biederman, Mick, & Faraone, 1998). Tic Disorders Tics are sudden, involuntary, repetitive movements involving a limited group of muscles. Still's (1902) research may be the first of its kind to note a comorbid condition of tics and ADHD. As many as 40 to 60% of children with tic disorders have a history of ADHD symptomatology (Comings & Comings, 1987; Goldman et al., 1998; Robertson, Trimble, & Lees, 1988). Symptoms may worsen once tics begin, as the child must now face another set of uncontrollable behaviors. Pharmacological Intervention Stimulant medication currently is one of the most common treatments for ADHD (Epstein et al., 1991). The

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51 belief that ADHD has a biological basis is supported by the positive effects of stimulant medications. Reportedly, response rate to stimulant medications varies from 70 to 96% (Elia, Borcherding, Rapoport, & Keysor, 1991). However, a person's response to medication is not a valid justification of the presence of ADHD (National Attention Deficit Disorder Association, 1998). Many parents support the notion that behaviors associated with ADHD can be treated with medication (Mellor et al., 1996). Successful medication use removes the focus from other etiological factors (e.g., psychosocial factors). A dysfunctional family relationship is thus eliminated as the cause of a child's ADHD, since poor parenting often is an underlying suspicion of many clinicians. Medications also may have a significant positive effect by reducing stress in parents (Swanson, McBurnett, Wigal, Pfiffner, Lerner, Williams, Christian, Tamm, Willcutt, Crowley, Clevenger, Khouzam, Woo, Crinella, & Fisher, 1993). Its use is convenient and does not disrupt family schedules. Stimulant Medications Stimulant medication was first proposed as a treatment for hyperactivity in the 1930s (Bradley, 1937), although pharmacology was not introduced for another two decades

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52 (Williams & Cram, 1978). Widespread use of stimulant medication for children with hyperactivity occurred during the 1960s. By the 1970s social concerns were raised with regard to the use of stimulant medication (Weithorn & Ross, 1976). Some suggested hyperactivity was a label physicians used to extend control over children's behavior through the use of drugs (Conrad, 1975; Schrog & Divoky, 1975). According to the Physicians' Desk Reference (1999), reasons why stimulant medications are effective remain unclear. Stimulants are believed to be associated with increased levels of neurotransmitters, such as dopamine and norepinephrine (Tan & Schneider, 1997). There is greater activity of neurochemicals in the parts of the brain that control the ability to attend and remain alert. Recent evidence in mice studies suggests that Ritalin and other psychostimulants may decrease hyperactivity by increasing the levels of serotonin, a neurotransmitter, in the brain (Gainetdinov, Wetsel, Jones, Levin, Jaber, & Caron, 1999). Stimulants reduce distractibility, enhance concentration, and decrease motor restlessness and hyperactivity, although they do not boost IQ or long-term academic performance (Merline, 1997). The three most commonly used stimulants are

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methylphenidate (i.e., Ritalin), dextroamphetamine sulfate (i.e., Dexedrine), and pemoline (i.e., Cylert). 53 Worldwide consumption of methylphenidate increased from 3 tons in 1990 to 5 tons in 1995, and was projected to reach 13 tons by 1997 (Ghodse & Kreek, 1998). The United States produces and consumes five times more methylphenidate than the rest of the world combined (Drug Enforcement Administration, 1995). Other countries are beginning to report an increase in the consumption of the drug as a treatment for ADHD (Ghodse & Kreek, 1998). The number of people taking Ritalin doubled between 1993 and 1995, and about three-fourths of the 2.6 million consumers of Ritalin are ADHD children aged 5 to 12 (Price, 1996). It is prescribed in more than 90% of children with ADHD who receive stimulant medication (DuPaul & Stoner, 1994; Goldman et al., 1998). The number of American children taking stimulant medications has doubled every two years since 1988 and should reach 8 million by the year 2000 (Guistolise, 1998). The United Nations is concerned about Ritalin "being passed out as freely as candy in the United States" (Light, 1997, p. 74).

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54 Antidepressant Medications Antidepressant medications, such as tricyclic antidepressants and monoamine oxidase (MAO) inhibitors, also are used to treat children with ADHD. Tricyclic antidepressants have a well-demonstrated ability in treating behavioral symptoms (Popper, 1997). Desipramine hydrochloride (i.e., Norpramin) and imipramine hydrochloride (i.e., Tofranil) may be used to treat ADHD. Monoamine oxidase (MAO) inhibitors often are effective for symptoms related to the disorder (Rapoport, 1986; Zametkin, Rapoport, Murphy, Linnoila, & Ismond, 1985). However, they have potentially greater adverse reactions than tricyclic antidepressants and require dietary restriction and monitoring (Sarason & Sarason, 1984). The United States Food and Drug Administration (FDA) has not approved either tricyclic antidepressants or monoamine oxidase (MAO) inhibitors for treating ADHD (Tan & Schneider, 1997) Antidepressants are not as widely used as stimulants due to severe adverse reactions. One of the most serious adverse reactions of tricyclic antidepressants is tachycardia (Biederman, Gastfriend, Jellinek, & Goldblatt, 1985; Puig-Antich, Ryan, & Rabinovich, 1985), which can be

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55 fatal with as few as 10 pills (Copeland & Copps, 1995). Cardiac arrhythmias, anticholinergic effects, and sudden death have also been reported (Ryan, 1990; Tan & Schneider, 1997). Desipramine hydrochloride also has been associated with growth defects in children (Spencer, Biederman, Wright, & Danon, 1992) and bone marrow depression (Block, 1996). The long-term effectiveness of tricyclics in treating ADHD is questionable (Copeland & Copps, 1995). Additional Medications The need for a variety of medications may be warranted, given the diversity of children who present with symptoms of ADHD and the limitations of their response to psychostimulants alone (Hunt, Lau, & Ryu, 1991). Adderall is one of the latest drugs being used for ADHD (Block, 1996). Fluoxetine hydrochloride (i.e., Prozac) has been tried both alone (Barrickman, Noyes, Kuperman, Schumacher, & Verda, 1991) and in combination with methylphenidate (Gammon & Brown, 1993). Bupropion hydrochloride (i.e., Wellbutrin) is successful in treating ADHD (Barrickman, Perry, Allen, Kuperman, Arndt, Herrmann, & Schumacher, 1995; Casat, Pleasants, Schroeder, & Parler, 1989; Simeon, Ferguson, & Van Wyck Fleet, 1986), exerting both antiaggressive and antihyperactive effects in some children (Hunt, Lau, Ryu,

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56 1991). Clonidine hydrochloride (i e., Catapres) can be beneficial in treating ADHD symptomatology (Hunt, Minderaa, & Cohen, 1985; Hunt et al., 1991; Wilens, Biederman, & Spencer, 1994); guanfacine hydrochloride (i.e., Tenex) reportedly is effective, less sedating, and longer acting than clonidine hydrochloride (Hunt, Arnsten, & Asbell, 1995). A combination of drugs for children's sleep disorders recently has been shown to alleviate the symptoms of ADHD including impulsive behavior and restlessness ("Sleep Disorder," 1998). Reasons For Not Using Medication as an Initial Treatment While effective in many cases, medication is not necessarily the best option as a first-line treatment of ADHD. Other consideration must be made before this intervention is utilized. Seven reasons have been suggested as a rationale for not choosing medication as an initial course of treatment (Copeland & Copps, 1995): 1. If medication is successful, there is little incentive to try other interventions that are needed for the long-term benefit of the child but require more investment of time and energy from parents and teachers 2. Research suggests that those children receiving medication alone did not have a better outcome by late adolescence than those who never received treatment.

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57 3. The amount of medication needed may be reduced after a child's allergies are treated, stress is reduced, organization, structure, and routine are implemented, and behavior management strategies are used effectively. 4. Parents are more comfortable with medication after other alternatives have been tried and their child continues to need intervention. 5. Children who may have been misdiagnosed or who do not need medication typically are very obvious after a few weeks of the use of other treatment. 6. Delaying medication insures adequate time to try other interventions. 7. Medication is less likely to be over-utilized or abused if important safeguards (e.g., careful assessment) are followed. Combining Medication with Other Interventions Current research does not support sustained treatment of ADHD with medication alone (Jacobvitz, Sroufe, Stewart, & Leffert, 1990) Many professionals believe medication should be used only after other appropriate interventions have been tried (Coleman & Levine, 1988), and never should be the sole treatment for ADHD (American Academy of Pediatrics, 1996) As the only method of management, the value of stimulants is limited (Pelham, 1993; Weiss, Kruger, Danielson, & Elman, 1975). At best, it is a short-term solution for many children (Ialongo, Horn, Pascoe, Greenberg, Packard, Lopez, Wagner, & Puttler, 1993). These limitations have led to an

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adoption of multimodal treatment for children with ADHD (Barkley, 1989a). 58 Evidence suggests that successful treatment of ADHD is related to the extended use of multimodal treatment (Rostain, Power, & Atkins, 1993). A combination of pharmacological and psychosocial treatments or behavior modification strategies is recommended since multiple impairments require multiple treatment modalities (Bramlett, Nelson, & Reeves, 1997; Swanson, Sergeant, et al., 1998). Despite support for multimodal treatment among medical practitioners, most children are prescribed Ritalin as their only treatment (Price, 1996). The two most commonly used paired treatments are stimulant medication and behavior modification (Barkley, 1990). The combination of these two has been found to be more effective than either used in isolation (Bramlett et al., 1997; Pelham & Murphy, 1986), and has been described as an optimal treatment approach for ADHD (Barkley, 1990). However, some believe medication alone is as effective as medication used in combination with any other treatment (Dawson, 1996). In practice, medication frequently is administered without any behavioral interventions (Evans, Ferre, Ford, & Green, 1995).

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59 While multimodal treatment can lead to good outcomes, there often is a lack of personnel who can research and implement them. Thus, some child and adolescent services will not accept referrals for ADHD. In addition, two recent well-controlled studies question the effectiveness of this multimodal approach (Ialongo et al., 1993; Pelham, Carlson, Sams, Vallano, Dixon, & Hoza, 1993). Opposition to the Use of Medications Opposition to the use of medication to treat children with ADHD arises from many sources. Adults feel apprehensive about giving children drugs that affect brain functioning and are used to control behavior (Copeland & Copps, 1995). Medication may be used indiscriminately. For example, children who are disruptive in the classroom may be treated with Ritalin even though they do not have ADHD ("Are Too Many Children," 1996). It appears the use of Ritalin may depend on parents' and teachers' ability to tolerate children's behavior (Bromfield, 1996a). Children who may have been misdiagnosed or who do not need medication typically are very obvious after a few weeks of other treatment (Copeland & Copps, 1995). Methylphenidate typically produces similar effects on children, even those without ADHD (Breggin & Breggin, 1995). Many physicians are

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60 using drugs as a diagnostic tool, believing that if the child improves, he or she must have ADHD (Livingston, 1997). This belief may lead a physician to prematurely end the search for a more proper diagnosis without considering disorders that coexist with ADHD and may jointly interfere with a child's functioning (National Attention Deficit Disorder Association, 1998) Medication, and more specifically Ritalin, is the most comm.on treatment for children with ADHD (DuPaul & Rapport, 1993). Given recent trends in managed care, many primary care physicians who prescribe medications often do not consult with school personnel or other health care professionals (McEwan, 1998). In addition, compliance with pharmacologic treatment of ADHD often is inadequate (Firestone, 1982; Sleator, 1985). Delaying medication insures adequate time to try other interventions. Several reasons have been given for not choosing medication as an initial treatment (Copeland & Copps, 1995) If medication is successful, there is little incentive to try other interventions that are necessary for the long-term benefit of the child but require more investment of time and energy from parents and teachers. The amount of medication needed may be reduced once a child's allergies are treated,

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61 stress is reduced, organization, structure, and routine are implemented, and behavior management strategies are used effectively. And parents are more comfortable with medication after other alternatives have been used and their child continues to need intervention. Thus, many considerations must be made before allowing a child to take stimulant medication, including: adverse reactions, unknown results from long-term use, abuse, ineffectiveness, and the financial aspects of prescribing medication. Adverse Reactions of Stimulant Medications The majority of children treated with stimulants experience some adverse reactions, ranging from mild to severe (Efron et al., 1997). Insomnia, decreased appetite, irritability, anxiety, headaches, and stomachaches occur in 20% to 50% of children treated with stimulant medication (Goldstein & Goldstein, 1990). Some children may experience a negative rebound effect at night once the medication wears off, and symptoms often are worse than if the child had never taken the medication (Reichenberg-Ullman & Ullman, 1996). Additionally, 3% of individuals cannot take Ritalin because of biochemical intolerance (Jordan, 1998). Adverse reactions are reversible with dosage reduction or drug withdrawal (Bramlett et al., 1997), however, and all traces

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of Ritalin are cleared from the brain within 24 hours of cessation (Jordan, 1998). Many children must take multiple medications in an effort to counteract chemically-induced adverse reactions (Hunker, 1998). 62 The potential for severe adverse reactions from stimulant medications must be considered. These may include liver dysfunction (Barkley, 1995; Jordan, 1998; Tan & Schneider, 1997), glaucoma (Armstrong, 1995), symptoms of psychosis (Braswell & Bloomquist, 1991), anorexia (Physician's Desk Reference, 1999), heart problems leading to sudden death (Armstrong, 1995), leukopenia (Findling & Dogin, 1998), depression (Breggin, 1998), motor and vocal tics (DuPaul, Barkley, & Connor, 1998), and permanent facial tics (Breggin & Breggin, 1995; Reichenberg-Ullman & Ullman, 1996; Tan & Schneider, 1997). The risk of triggering tics associated with Tourette's Syndrome also is of major concern (Cherkes-Julkowski, Sharp, & Stolzenberg, 1997; Shaywitz & Shaywitz, 1991b), especially since this disorder is irreversible (Patterson, 1996). However, stimulant medications may only trigger tic disorders when a genetic predisposition exists (Erenberg, Cruse, & Rothner, 1985). The effect of stimulant medications on children's height is another concern. A decrease in the rate of growth

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occurs when Ritalin disrupts the cycles of growth hormone released by the pituitary gland. This negative effect has been recorded after only one or two years of treatment 63 (Greenhill, Puig-Antich, Chambers, Rubinstein, Halpern, & Sachar, 1981). A significant decrease can occur after two to four years of Ritalin use (Mattes & Gittelman, 1983). High doses continuously consumed over a number of years are more likely to suppress growth than lower doses (Sears & Thompson, 1998). Nevertheless, height tends to normalize during adolescence (Spencer, Biederman, Harding, O'Donnell, Faraone, & Wilens, 1996). Unknown Results From Long-term Use of Medications The Physicians' Desk Reference (1999) acknowledges there are insufficient data on the safety and efficacy of long-term use of stimulants by children. Some children receive drug treatment for extended periods of time without proper evaluation by professionals (e.g., psychologists, speech pathologists, educational diagnosticians) and without continuing evaluation during their therapy (American Academy of Pediatrics, 1996). Children in the United States also are prescribed the drug for longer periods of time than children in other countries ("Agency Survey," 1996).

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64 The full effects stimulant medications will have on children's bodies are unknown. There is concern that harmful effects may occur many years after treatment ends. Few children who were treated extensively with stimulant medications have reached middle age (Jacobvitz et al., 1990). Thus, follow-up research must be conducted to determine possible deleterious effects. Abuse Ritalin has become a popular recreational drug (Reichenberg-Ullman & Ullman, 1996). It has been referred to as pediatric cocaine (Block, 1996). Ritalin is regulated by the DEA in the same category as cocaine, morphine, PCP, codeine, and methadone (Price, 1996). Schedule II controlled substances such as Ritalin, drugs for which prescriptions are carefully monitored, "have a high abuse potential with severe psychological or physical dependence liability" (DiGregorio & Barbieri, 1998, p. 263). One physician notes the extensive procedure involved in prescribing and filling the prescription, given its dangerous potential: Doctors who prescribe it are required to obtain an expensive narcotic license, renew it every two years, and write the prescription (with annoying perfection) on special triplicate prescription pads provided by the DEA. The doctor retains a copy, the pharmacy retains a copy, and the DEA retains a copy. A prescription for Ritalin cannot be called into the pharmacy over the

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65 phone; instead, the completed official prescription form must be mailed or handed directly to the patient. If the doctor forgets to cross a! or dot an~' the pharmacist must send it back, for fear that someone may have tampered with the prescription. The point is, everyone involved with prescribing Ritalin takes it seriously, especially the doctor, the pharmacist, and the DEA. So must everyone else. (Sears & Thompson, 1998, p. 232) Prescriptions for Ritalin have increased 600% since 1990, with a large portion of the drugs diverted for illicit use (Bailey, 1995). The DEA has received reports of street sales, drug rings, illegal importation, and illegal sales by health professionals (Goldman et al., 1998). Ritalin has ranked in the top 10 most frequently reported controlled pharmaceuticals stolen from licensed handlers (Drug Enforcement Administration, 1995). Drug abuse injury reports involving Ritalin for children ages 10 to 14 have increased 1,000% (Haislip, 1996). Psychotic episodes and violent behaviors are associated with chronic abuse of Ritalin (Merline, 1997). Ritalin-related visits to emergency rooms for 10-14 year olds have increased 10-fold and now are at the same level as cocaine (Haislip, 1996). Hospital admissions have increased fivefold since 1990 (Merline, 1997). The United Nations International Narcotics Control Board has reported an increase in the number of teenagers

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66 inhaling Ritalin (Bromfield, 1996b). A survey of high school students indicated that more seniors in the United States abuse Ritalin than are prescribed legitimately (Drug Enforcement Administration, 1995). The number of high school seniors who admitted abusing the drug doubled to 350,000 from 1993 to 1994 (Reichenberg-Ullman & Ullman, 1997). White and suburban abusers are more likely to snort Ritalin, while African-American inner-city abusers are more likely to inject it (Bailey, 1995). As many as 15 to 20% of the children in some communities have been placed on Ritalin or a similar stimulant; thus, "there is good reason to conclude that this is a 'quick-fix', bogus medical practice which is nevertheless producing large profits" (Haislip, 1996, p. 2). In the United States, ADHD is diagnosed most commonly in wealthy suburbs where parents often expect their children to be high academic achievers (Toufexis, 1989). There is the potential for abuse by adolescents and their parents who inappropriately seek stimulants to enhance the ability to study for higher level exams (Mellor et al., 1996) or to succeed in school (Debroitner & Hart, 1997). Abuse of Ritalin can result in psychotic episodes, violent behavior, tolerance, and severe psychological dependence (Price, 1996).

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67 Ineffectiveness Not all children with hyperactivity respond to stimulant medication. As many as 40% may show no response (Reichenberg-Ullman & Ullman, 1996), and those who do respond may not respond fully (Williams & Cram, 1978). This lack of response to its use may be attributed to the finding that half of every dose of Ritalin may contribute nothing to its therapeutic effect (Wu, 1998). One of two molecular forms found in Ritalin was shown to offer little benefit, while contributing to the drug's adverse reactions. Among children who respond to stimulant medication, drug therapy rarely is sufficient to bring them within a normal range of academic and social functioning (Pelham, 1993). Some studies have failed to confirm improvement in ADHD symptoms (McGuiness, 1989; Baughman, 1993; Breggin & Breggin, 1994; Walker, 1996), including improvement in retention of learning, overall achievement, or control of anger (Weintraub, 1997). Several reasons have been offered to explain this phenomenon: studies may be short-term, dosages may have been inadequate, and dose-response relationships may be different for different domains (Goldman et al., 1998).

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68 Persons with a type of ADHD attributed to one etiology do not respond to medication. Approximately 93 % of children with right hemisphere syndrome, one genetic form of ADHD display characteristics of ADHD (Voeller, 1986). Persons with this common form of ADHD are very difficult to treat with medications unless a drug-treatable comorbidity (e.g., conduct disorder, depression) exists (Popper, 1997). Despite decades of research, no demonstrable long-term benefits of stimulant medication have been noted (Swanson & Kinsbourne 1980a). A lack of data showing continued or lasting effects from medication suggest its long-term effectiveness cannot be supported (Jacobvitz et al 1990). In addition, the effects from long-term use of stimulants on children's growing bodies are unknown (Ullman, 1988). Several explanations have been offered to account for a lack of long-term benefits from the use of stimulant medication (Jacobvitz et al., 1990) Drug treatment alone may be an adequate treatment for most children A tolerance for the medication may develop and drug effects may disappear over time Children with attentional and behavioral problems represent a very heterogeneous group If a subset has a specific biochemical abnormality, positive effects of medication may be obscured

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69 Financial Aspect One cannot overlook the financial aspect of medication. Medicating children with ADHD at an early age often gains a customer for life. Stimulant medications have been over promoted, over-marketed, and over-sold, resulting in annual profits of approximately $450 million (Haislip, 1996). Because pharmaceutical companies are making large profits from the diagnosis and treatment of ADHD, drug treatment is unlikely to stop, even if drugs are found not to be the best treatment (Block, 1996). There clearly is greater financial profit in getting doctors, parents, and teachers to treat the disorder with medication instead of other therapies (Johnson, 1998). Alternative Treatments The popularity of complementary and alternative medicines (CAM) has grown in recent years. The use of CAM with children also is increasing (Spigelblatt, 1995). Visits to alternative medicine practitioners in the United States increased 47%, from 427 million in 1990 to 629 million in 1997 (Eisenberg, Davis, Ettner, Appel, Wilkey, Van Rompay, & Kessler, 1998), compared to only 386 million visits to primary-care physicians (Cowley & Underwood, 1998). Over half of all conventional physicians in the United States use

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or refer patients for alternative treatments (Astin, 1998; Blumberg, Grant, Hendricks, Kamps, & Dewan, 1995; Ernst, 1995). An estimated $32.7 billion is spent annually on services of practitioners of alternative therapies (Eisenberg et al., 1998). 70 CAM are intended to be complementary and compatible with conventional medicine. It includes practices requiring highly specialized and competent practitioners, over-the counter products, and self-care techniques. Many patients use alternative medicine either because they are attracted to CAM philosophies and health beliefs, or because they are not satisfied with the process or results of their conventional care (Furnham & Forey, 1994). Some believe every effort should be made to investigate alternatives before beginning drug therapy (Friedman & Doyal, 1992). In an attempt to find more natural treatments for ADHD, many parents seek a complementary or alternative treatment for their children (Spencer & Jacobs, 1999). A number of these treatments for children with ADHD have been utilized, with varying success, including iron treatment, Feingold Diet, neurofeedback, homeopathy, herbal medicine, and dietary supplements.

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71 Iron Supplementation Iron deficiency is the world's most prevalent nutritional disorder (Weintraub, 1997). Evidence suggests iron deficiency has behavioral effects (Sever, Ashkenazi, Tyano & Weizman, 1997). A deficiency affects motor behaviors and cognitive function, and iron level may play a part in motor hyperactivity, poor cognitive learning, and attention deficit. Many children with ADHD have low levels of iron and other trace elements, and the use of iron treatment for a deficiency significantly improves behavior and intellectual attainment (Deinard, Murray, & Egeland, 1976; Pollitt & Leibel, 1976; Weintraub, 1997; Yehuda, Youdim, & Matofsky, 1986). There also may be some benefit to iron supplementation in ADHD children who are non-iron-deficient (Sever et al., 1997). Feingold Diet The Feingold Diet was created to teach parents how children with behavioral, learning, and health problems can be helped by the elimination of certain foods and synthetic chemicals. The two stage elimination diet was created by pediatrician Ben Feingold (Feingold Association, 1983). The first stage (Table 1) involves an initial period when foods containing synthetic colors and flavors, antioxidant

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Table 1 Feingold Diet, Stage 1 Initial period during which two groups of foods are eliminated Group 1: Eliminate foods containing: 72 Synthetic colors. Listed as "U.S. Certified Color," or by its FDA number, such as "FD&C Yellow No 5. Synthetic favors. May be listed as "flavoring" or "artificial flavoring." Three antioxidant preservatives: BHA (Butylated Hydroxyanisole) BHT (Butylated Hydroxytoluene) TBHQ (Monotertiary Butylhydroxylquinone) Group 2: Eliminate foods containing natural salicylates, such as: Almonds Apples Apricots Cherries Cucumbers Grapes and raisins Green peppers Oranges Peaches Plums Tea Tomatoes Aspirin and medication containing aspirin also are eliminated. Source: Feingold Association. (1983). Feingold handbook, page 3. Alexandria, VA: Feingold Association.

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preservatives, and natural salicylates are eliminated. The second stage (Table 2) includes a reintroduction of foods with natural salicylates. Foods are added and tested individually to determine if the child can use some or all of them without a negative change in behavior. 73 Feingold's proposed diet received widespread support despite a lack of corroborating controlled clinical trials, and many parents were convinced their children were reacting adversely to ingested synthetic colorings (Rowe, 1988). Five factors have been suggested to account for the attractiveness of Feingold's hypothesis (Williams & Cram, 1978): it offers a natural alternative to drug therapy, it alleviates the guilt parents feel by putting the blame on food, it removes blame from the schools, it is consistent with the growing awareness of ecology and pure foods, and it allows parents to control their child's diet, thus enabling them to become the primary therapeutic agents. In addition, parents are attracted to the diet treatment because of dissatisfaction with other therapies (Harley & Matthews, 1978) Research investigating food additives as the cause of hyperactivity or learning problems in children has been mixed (Conners, 1980a, 1980b; Lipton & Mayo, 1983; Mattes,

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74 Table 2 Feingold Diet, Stage 2 After a favorable response has been observed for four to six weeks, the foods in Group 2 may be carefully reintroduced and tested one at a time. Foods in Group 1, from Stage 1, are never reintroduced. Examples of Fruits Allowed: Banana Cantaloupe Dates Grapefruit Lemons Limes Papaya Pears Pineapple Watermelon Examples of Vegetables Allowed: Asparagus Beans (all types) Broccoli Carrots Celery Lettuce Onions Peas Potatoes, white and sweet Pumpkin Spinach Squash Source: Feingold Association. (1983). Feingold handbook, page 4. Alexandria, VA: Feingold Association. 1981; Wender, 1986). Empirical research (e.g., Boris & Mandel, 1994; Carter, Urbanowicz, Hemsley, Mantilla, Strobel, Graham, & Taylor, 1993; Egger, Carter, Graham, Gumley, & Soothill, 1985; Egger, Stolla, & McEwen, 1992; Kaplan, McNicol, Conte, & Moghadam, 1989a; Pollock & Warner, 1990; Rowe & Rowe, 1994; Salzman, 1976) and anecdotal

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75 reports (e.g., Cook & Woodhill, 1976; Swanson & Kinsbourne, 1980b; Weintraub, 1997; Williams, Cram, Tausig, & Webster, 1978) support Feingold's theory. Evidence suggests from 30 to 50% (.Feingold, 1976) of children on the Feingold diet display behavioral improvement However, many empirical studies have either discredited this relationship or yielded inconclusive results (e.g., Connors, Goyette, Southwick, Lees, & Andrulonis, 1976; Cook & Woodhill, 1976; David, 1987a; Goyette, Connors, Petti, & Curtis, 1978; Gross, Tofanelli, Butzirus, & Snodgrass, 1987; Harley, Matthews, & Eichman, 1978; Harley, Ray, Tomasi, Eichman, Matthews, Chun, Cleeland, & Traisman, 1978; Levy, Dumbrell, Hobbes, Ryan, Wilton, & Woodhill, 1978; Mattes, 1980; Mattes, & Gittleman, 1981; Mattes & Gittelman-Klein, 1978; Rowe, 1988; Weiss, Williams, Margen, Abrams, Caan, Citron, Cox, McKibben, Ogar, & Schultz, 1980; Williams, Cram, Tausig, et al., 1978). Ironically, while many are skeptical of the relationship between artificial colors and ADHD, the Physicians' Desk Reference (1999) notes Ritalin sustained-release tablets are available in a color-additive free form. These data may not offer an accurate interpretation. Some results are questionable because of logistic and methodologic problems (Conners, 1980b; National Advisory

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76 Committee on Hyperkinesis and Food Additives, 1980; Rippere, 1983). Impediments include the lack of a control group (Tryphonas, 1979), uncertainties about which part of the diet is of significance (Rowe, 1988), parental identification of differences between the Feingold and placebo diets (Conners et al., 1976), dietary compliance (Gross et al., 1987; Tryphonas, 1979), possible lack of inertness of the control substance (Rippere, 1983), varying diagnostic criteria for hyperactivity (American Psychiatric Association, 1968, 1980, 1987, 1994; Biederman, Newcorn, et al., 1991; Halpern et al., 1992; Hinshaw, 1987; Pliszka, 1992; Shaywitz & Shaywitz, 1991a; World Health Organization, 1978), identification of responding children from heterogeneous populations (Rowe, 1988), placebo or "Hawthorne" effect (Brenner, 1977; Spring & Sandoval, 1976; Wender, 1977; Williams, Cram, Tausig, et al., 1978), the expense and difficulty of satisfactorily implementing double-blind conditions (Conners et al., 1976; Harley, Ray, et al., 1978; Williams, Cram, Tausig, et al., 1978), doubts about the validity and reliability of outcome measures (Rowe & Rowe, 1992), insufficient dependent measures to assess treatment effects (Trites et al., 1980), and detection of treatment effects when only a small number of children

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respond (Cox, 1981; Dews, 1982/1983; Harley, 1981; Rowe, 1988; Schwab & Conners, 1986). 77 Several concerns have been raised with regards to children being placed on the Feingold Diet without physician supervision (David, 1987b). Children have suffered anaphylactic reactions to certain dietary elements that were previously restricted from their diet. They may be starved of essential nutrients by highly-restricted diets implemented by parents. Dietary treatment is expensive and requires the time of several medical personnel. In addition, restricting the child's diet can be unrealistic and impossible to monitor outside of the home. Two groups worked independently to address the claims of Feingold's hypothesis. The National Commission on Hyperkinesis and Food Additives was established by the Nutrition Foundation, a group formed by the food industries in the United States. The Interagency Collaborative Group on Hyperkinesis was created by the United States Department of Health, Education and Welfare The groups reached the following conclusions (Williams & Cram, 1978): the hypothesis was based on clinical findings and not on rigorous clinical trials or experimental research, the hypothesis was derived from intuitions and clinical

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78 experience rather than being based on the scientific principles of biochemistry and nutrition, and systematic clinical trials and strict experimental designs were required to test the hypothesis and the effectiveness of the diet Neurofeedback The term biofeedback" was first used in the 1960s. It describes procedures used to train research subjects to alter their brain activity, blood pressure, heart rate, and other functions not normally voluntarily controlled (Runck, 1983). The treatment technique allows individuals to improve their health by using signals from their own bodies. Neurofeedback, or EEG biofeedback, training has been applied to a number of neurological, psychological, and psychosomatic conditions (e.g., Hartje, 1980; James & Folen, 1996; Tansey 1993) The goal of neurofeedback is to improve mental flexibility so a person can produce a mental state appropriate for a particular situation (e.g., completing classwork) (Sears & Thompson, 1998). Research has established the effectiveness of neurofeedback in treating individuals with ADHD (Lubar & Shouse, 1976; Othmer, 1997). It is one of the fastest-growing applications of biofeedback and a relatively new approach to the treatment and long term

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79 management of ADHD (Othmer, Kaiser, & Othmer, 1995), and neurofeedback generally is accepted by allopathic physicians (Laken & Cosovic, 1995). Differences in EEG are present in children with ADHD and those without the disorder (Kuperman et al., 1996; Lazzaro, Gordon, Whitmont, Plahn, Li, Clarke, Dosen, & Meares, 1998 ; Lubar, 1991; Othmer & Othmer, 1992a). Neurofeedback has been found to remediate the underlying condition of physiological underarousal in hyperactivity (Lubar & Lubar, 1976). Thus, symptoms of ADHD may arise from a disregulated EEG, in combination with genetics, trauma, and other factors that can be attributed to the onset of the disorder (Othmer & Othmer, 1992a). Neurofeedback can help ameliorate the problems associated with ADHD (Lubar, 1995) (Table 3). It is a method for repeatedly exercising the pathways of attention and impulse control, thereby facilitating their growth and development (Sears & Thompson, 1998). The use of neurofeedback has resulted in increased attention, impulse control, and speed of information processing on the Test of Variables of Attention (Cartozzo, Jacobs, & Gevirtz, 1995; Kaiser, 1997; Kaiser & Othmer, 1997; Rossiter & LaVaque, 1995; Scheinbaum, Zecker, Newton, & Rosenfield, 1995) and

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80 Table 3 Application of and Results from Neurofeedback Treatment Anyone with a primary diagnosis of ADD or ADHD, between the ages of 7 and 45, with low-average, average, or above average intelligence is a candidate. Neurofeedback treatment should not be offered with comorbidity of: Mental retardation Childhood psychosis Severe depressive or bipolar illness Significant seizure disorder where medications interfere with learning (i.e. sedating medications) Hyperkinesis, where multiple medications or high dosage with monotherapy have been ineffective Learning disabilities without ADD and ADHD as a primary problem Dysfunctional families who refuse to participate in indicated therapy Symptoms that can be improved with neurofeedback: Attention, focus, and concentration Task completion and organizational skills Impulsivity Mild hyperactivity Results of treatment : Improved behavior and learning Improvement in school grades Increased self-esteem Better job performance Greater realization of innate potential Higher intelligence test scores Improved scores on parent-teacher rating scales Source: Lubar, J. F. (1995). Neurofeedback for the management of attention-deficit/hyperactivity disorders. In M. Schwartz, Biofeedback : A practitioner's guide, pp. 506507. New York : Guilford Press.

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81 improved scores on the Freedom from Distractibility factor of the Wechsler Intelligence Scale for Children-Revised (Cartozzo et al., 1995). Behavior Assessment Scale for Children (BASC) questionnaires completed by mothers also confirm a reduction in ADHD symptoms (Rossiter & LaVaque, 1995). Results indicating a significant reduction of symptoms are consistent with other studies (Linden, Habib, & Radojevic, 1996; Lubar, 1991; Lubar, Swartwood, Swartwood, & O'Donnell, 1995). Research indicates the success rate for biofeedback training is approximately 85% (Sears & Thompson, 1998). Although the treatment has been used successfully with more than 3000 children in over 300 health care organizations (Lubar, 1995), Russell Barkley, an expert in the field of ADHD research, disputes the claims of neurofeedback as an effective intervention (personal communication, February 16, 1998). Homeopathy Homeopathy is the method of using any of more than 2,000 remedies with the power to resonate with the illness, in contrast with the more traditional method of opposing symptoms with great force (Jacobs & Moskowitz, 1996). The medical theory and practice developed in reaction to the bloodletting, blistering, purging, and other harsh

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82 procedures of conventional medicine as it was practiced 200 years ago (Stehlin, 1997). Samuel Hahnemann, an 18th century German physician and chemist discouraged with these methods, developed a theory based on three principles: the law of similars, the minimum dose, and the single remedy (Jacobs & Moskowitz, 1996). The law of similars states that if a large amount of a substance causes certain symptoms in a healthy person, smaller amounts of the same substance can be used to treat the symptoms in an ill person (Reichenberg-Ullman & Ullman, 1996). Since symptoms are defenses of the body, it is best to aid rather than suppress them (Ullman, 1988). Conventional medicine applies this principle to immunizations and allergy treatments. Homeopathic remedies stimulate an ailing self-healing mechanism rather than correcting a specific problem; thus, large doses rarely are required and may even spoil the effect (Jacobs & Moskowitz, 1996). With a minimum dose, the strength and effectiveness of a substance increases the more it is diluted. Small doses decrease any chance that dangerous adverse reactions will occur. A single remedy generally covers all of the symptoms a patient is experiencing (Stehlin, 1997). Remedies made from

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a variety of sources (e.g., plants, minerals, animals) are prescribed based on a person's symptoms. The use of multi ingredient remedies is recognized as part of homeopathic practice. 83 Homeopathy is widely used to treat a variety of health problems. Approximately 500 million people worldwide receive homeopathic treatment (Burton Goldberg Group, 1997), and it is the second most popular form of CAM used by children (Spencer & Jacobs, 1999). Treatments have been shown to be effective for both common and chronic ailments, such as allergies (Reilly, Taylor, Mcsharry, & Aitchison, 1986; Wiesenauer & Ludtke, 1995), asthma (Reilly, Taylor, Beattie, Campbell, Mcsharry, Aitchison, Carter, & Stevenson, 1994), childhood diarrhea (Jacobs, Jimenez, Gloyd, Gale, & Crothers, 1994), fibromyalgia (Fisher, 1986; Fisher, Greenwood, Huskisson, Turner, & Belon, 1989), hyperactivity (Frederick, 1998; Reichenberg-Ullman, 1997; Ullman, 1988), influenza (Davies, 1971; Ferley, Zmirou, D'Adhemar, & Balducci, 1989), irritable colon (Owen, 1990), migraines (Brigo & Serpelloni, 1991), and rheumatoid arthritis (Gibson, Gibson, MacNeill, & Buchanan, 1980). Two doctors of naturopathy claim a 70% success rate using homeopathic methods for at least one year with nearly 1,000 children

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84 with ADHD (Reichenberg-Ullman & Ullman, R., 1996). Evidence supporting its efficacy in placebo controlled-trials is surfacing (Linde, Clausius, Ramirez, Melchart, Eitel, Hedges, & Jonas, 1997). A meta-analysis of 25 years of controlled clinical studies using homeopathic medicines produced the following results: 81 showed homeopathic medicines were effective, 24 showed they were ineffective, and 2 were inconclusive (Kleijnen, Knipschild, & ter Riet, 1991) The use of homeopathy has increased over the last few decades, and its popularity is evidenced throughout the world, especially in Europe, Latin American, and Asia (Jacobs & Moskowitz, 1996). One-fourth of all physicians in Germany use homeopathy (Ullman, 1991), while one-third of general practice physicians in France engage in its use (Bouchayer, 1990). Sales of homeopathic remedies in the United States increased by 1,000 percent during the 1980s (Jacobs & Moskowitz, 1996). In 1995, retail sales of these medicines were estimated at $201 million and growing at a rate of 20 percent (Stehlin, 1997). Herbal Medicine Interest in and actual use of herbs has dramatically increased during the last two decades. Fifteen years ago,

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85 none of the top 250 pharmaceutical companies had a program to investigate plant-based medicines, although over half now have programs to examine their efficacy (Vincent & Furnham, 1997). Despite the utilization of a large number of herbal medicines, less than 10% of the estimated 250,000 flowering plant species have been investigated for their scientific potential (Vincent & Furnham, 1997). Thus, choosing new herbs for investigation can be difficult. Research continues to uncover possible treatments and cures among these plants, guided by knowledge of the plants currently used by different cultural groups for medical purposes (Meserole, 1996). Herbal remedies are growing in popularity in the United States. Americans spent $12 billion for herbals, vitamins, minerals, and sports and speciality supplements in 1997 ("Herbal Rx," 1999). This figure is approximately 30% greater than that from two years earlier. Herbal medicines offer a viable alternative treatment for a variety of disorders (Cassileth, 1998). They have earned the attention of parents and medical professionals interested in finding an alternative to pharmacological treatment of ADHD (Weintraub, 1997). Researchers have identified two particular herbs, Ginkgo biloba and lemon

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balm, that are useful in treating symptoms commonly associated with ADHD (Weintraub, 1997). Ginkgo biloba 86 Ginkgo biloba is one of the oldest living tree species, dating back over 200,000 years. Much of the tree's original territory was wiped out during the last Ice Age, although today the tree survives in northern China and Japan (Burton Goldberg Group, 1997). In China, extracts of the fruit and leaves of the Ginkgo tree have been used as a remedy for over 1,000 years (Pang, Pan, & He, 1996). In Germany, Ginkgo extracts are among the most widely used herbal medicines (Jones, 1998). Because the extract increases blood circulation to the brain and increase oxygen levels in brain tissues, it is used primarily in an effort to improve mental clarity and alertness (Hobbs, 1991). It also has been shown to improve the cognitive function of demented patients (LeBars, Katz, Berman, Itil, & Freedman, 1997). The treatment is somewhat effective for disorders of the brain, such as dementia and memory impairment ("Boost Brain Power," 1998; Itil & Martorano, 1995; Kanowski, Herrmann, Stephan, Wierich, & Horr, 1996; LeBars et al., 1997; Oken, Storzbach, & Kaye, 1998; Pang et al., 1996; Rai,

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87 Shovlin, & Wesnes, 1991; Soholm, 1998). In a review of 40 controlled trials, nearly all trials reported at least a partial positive outcome in patients with cerebral insufficiency (Kleijnen & Knipschild, 1992). Cerebral insufficiency is a general term for a collection of symptoms that include difficulties of concentration and memory, absentmindedness, confusion, lack of energy, depressive mood, anxiety, dizziness, tinnitus, and headache. Melissa officinalis Melissa officinalis, or lemon balm, contains nervine principles that help restore the balance and function of the brain and nerve cells. It has a mild relaxing effect, making it a good treatment for children with hyperactivity (Anderson & Peiper, 1996; Klein, 1998; Mendola, 1996) and other symptoms related to ADHD (Bell & Peiper, 1997). Dietary Supplements Dietary supplements are used to treat a variety of disorders and, because they are readily available, are used by parents wishing to self-treat their children (Weintraub, 1997). Supplements do not cure a disorder; rather, they treat the symptoms and underlying causes. Many dietary supplements are used to treat ADHD symptomatology, and

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popular choices include grapine, dimethylaminoethanol, Glutamine, and an essential fatty acid. Grapine 88 Grapine is derived from both the bark of the French Maritime Pine tree and grape seed (Elkins, 1995). Grapine is very similar to Pycnogenol, a nutritional compound from France once comprised only of the tree bark but now also derived from grape seeds (Walji, 1996). Original research showing the power of Pycnogenol was done with grape seed extract and is essentially equivalent in function (Eidelman, 1997) Children with ADHD have found grapine somewhat effective in decreasing their symptoms by normalizing brain function (Rapp, 1998; Weintraub, 1997). It is a high potency antioxidant known to cross the blood-brain barrier to facilitate the flow of oxygen to the brain and central nervous system, improving problems with inattentiveness and hyperactivity (Anderson & Peiper, 1996), as well as memory, recall, and concentration (Bell & Peiper, 1997). It often is used in France to control symptoms of ADHD. Many Americans are using it as an alternative to Ritalin (Debroitner & Hart, 1997).

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89 Dimethylaminoethanol Dimethylaminoethanol (DMAE) is a choline precursor that easily crosses the blood-brain barrier. It normally is present in small quantities in our brains and is thought to improve memory and learning, intelligence, and to elevate moods (Weintraub, 1997). Seafood (e.g., sardines, anchovies) is naturally abundant in DMAE, supporting the notion that fish is good "brain food". A diet high in seafood will provide higher than average levels of DMAE and choline to the brain, ingredients that serve as raw materials for the production of the neurotransmitter acetylcholine. Acetylcholine is responsible for conducting nerve impulses within the brain. L-Glutamine L-Glutamine is an amino acid that penetrates the barrier separating the brain from the rest of the body's circulatory system. It helps create the transmitters in the brain that enhances learning and memory, and has increase the IQs of mentally impaired children (Rogers & Pelton, 1957). Once inside the brain, it has the unusual ability to provide fuel for brain cells, thus improving mental alertness, and clarity of thinking and mood (Cecchi, 1976). Glutamine has been found to be deficient in children with

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90 ADHD (Sahley, 1997). Supplementation may help improve concentration, alertness, memory, and recall (Bell & Peiper, 1997). Some children with ADHD have displayed an improvement in their symptoms after taking glutamine, and some believe glutamine and Ginkgo biloba are an effective combination that promotes concentration, memory, and on-task behavior (Sahley, 1997). Essential fatty acids Many children with ADHD cannot metabolize or absorb essential fatty acids (EFAs) normally (Colquhoun & Bunday, 1981). These acids are important energy-supplying molecules; about 20 specific fatty acids are required by the human body to maintain normal function (Weintraub, 1997). High concentrations of EFAs are found in the brain, and they aid in the transmission of nerve impulses and are needed for the proper brain functioning. Flaxseed, for example, is rich in omega-3 essential fatty acids (Balch & Balch, 1997) EFAs have been found in lower concentrations in the plasma polar lipids and in red blood cell total lipids of ADHD subjects (Stevens, Zentall, Deck, Abate, Watkins, Lipp, & Burgess, 1995). A deficiency of EFAs can contribute to a variety of physical changes, including an impaired ability to learn and recall information (Stevens, Zentall, Abate,

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Zuczek, & Burgess, 1996) and learning disabilities (Lee, 1997). Essential fatty acid supplementation has been shown to improve problems with attention and motor excess as measured by the Revised Behavior Problem Checklist and performance tasks (Aman, Mitchell, & Turbett, 1987). 91 Like most physical disorders, a deficiency manifests itself in a particular manner. Increased thirst is a primary symptom of an essential fatty acid deficiency (Burr & Burr, 1930). Surveys of children with ADHD have shown them to be more thirsty than children without this disorder (Mitchell, Aman, Turbett, & Manku, 1987). Gender may be associated with the presence EFAs. Males have much higher requirements for EFAs than females, and are much more commonly affected by a deficiency than are females (Colquhoun & Bunday, 1981). A lack of EFAs would affect more boys and possibly account for the greater prevalence of ADHD among males (Mitchell, 1984). Classroomand Home-based Interventions Although medications and other therapies represent the primary intervention for children with ADHD, adjunctive techniques may be necessary to deal with more severe symptoms, including behavioral difficulties (DuPaul &

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92 Stoner, 1994). The National Association of School Psychologists' (1991) position statement on attention deficits outlines several interventions (Table 4). Effective interventions fall into three categories: modifying the environment in which the student lives and learns, modifying the behavior of the student, and modifying the attitudes and beliefs of those who work directly with the student (Dawson, 1995) Classroom-based Interventions Greater expectations for using classroom-based interventions are caused in part by the Individuals with Disabilities Education Act (IDEA) of 1997 (Brock, 1998). Environmental efforts should be implemented at the earliest stage of treatment (Cohen, 1998). Classroom or environmental management may include several dimensions that should be considered to help them meet their needs, including: instructional, psychosocial, physical, procedural, behavioral, cognitive-behavioral, psychological, and the use of support personnel. Instructional Time management is an important element in classroom management. Teachers must make specific considerations when developing daily schedules (Gallagher, 1979), such as:

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93 Table 4 Effective Interventions for Children with Attention Deficits Effective interventions should include the following: 1. Classroom modifications to enhance attending, work production, and social adjustment. 2. Behavior management systems to reduce problems in areas most likely to be affected by attention deficits. 3. Direct intervention in study strategies and social skills, within the classroom setting whenever possible to increase generalization. 4. Consultation with families to assist in behavior management in the home setting and to facilitate home school cooperation and collaboration. 5. Monitoring by a case manager to ensure effective im~lementation of interventions, to provide adequate support for those interventions, and to assess programs in meeting behavioral and academic goals. 6. Education of school staff in characteristics and management of attention deficits to enhance appropriate instructional modifications and behavior management. 7. Access to special education services when attention deficits significantly impact school performance. 8. Working collaboratively with community agencies providing medical and related services to students and their families. Source: National Association of School Psychologists. (1991). Position statement: Students with attention deficits. Bethesda, MD: Author.

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94 provide students with a daily schedule, schedule work that can be completed by the end of the period or day, plan for flexible time to allow the completion of assignments, require students to complete one task before moving on to another, always plan ahead and anticipate what students will need, and provide positive feedback whenever possible. It also may be best to provide academic instruction in the morning when problem solving skills are better (Pfiffner & Barkley, 1990). The presentation of material is important. Adjusting instructional methods can positively impact a child with ADHD. Six suggestions have been made to promote the opportunity for success in the classroom (Stevens, 1997): keep directions clear and simple, avoid giving multiple assignments, avoid techniques based on sequencing, avoid techniques based on directional patterns, spare the child the embarrassment of demonstrating his weaknesses in front of his classmates, and avoid instructional methods that require a great deal of independent work. Often, changes made by the teacher rather than the student can lead to success. Children with ADHD have a very difficult time following multi-step directions. Thus, instructions should be short,

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95 specific, and direct (Goldstein & Goldstein, 1990). It may also be beneficial if children rephrase directions in their own words (Westby & Cutler, 1994). Adjunctive techniques may be used in the classroom to help student learning. Lesson outlines may help to increase memory of main ideas (Brock, 1998). Essays help relieve the confusion of multiple-choice tests and computerized sheets (Buncher, 1996). Psychosocial Many children with ADHD have a need for interventions focusing on the development of social skills, as their behaviors make it have difficult to acquire age-appropriate skills (Landau & Moore, 1991; Lerner et al., 1995). More than half of the children have peer-relation problems (Guevremont, 1990). Social skills training provides them with successful peer contacts, increases their knowledge of appropriate behavior and adaptive social skills, promotes successful peer interactions in the natural environment, and alters their social status in the peer group (Guevremont, 1993). Training programs should promote self-regulation and offer frequent opportunities for practice and self monitoring (Dowdy, Patton, Smith, & Polloway, 1998).

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96 Physical The classroom physical environment has a significant influence on a student's nonacademic activities (e.g., behavior) (Lewis & Doorlag, 1995). Small working spaces can increases the opportunity for behavioral problems. Hyperactive children often are less disruptive when seated at one end of the back row (Stevens, 1997). Wall displays also may be a great distraction, although research has not supported the effectiveness of removing all irrelevant stimuli (Abramowitz & O'Leary, 1991; Pfiffner & Barkley, 1990). Procedural The establishment of rules is necessary in any classroom. Children must know what is expected of them and the consequences that will occur if rules are not followed. Rules for children with ADHD must be well-defined, specific, and reinforced through visible and external forms of presentation (Brock, 1998). Relying on the student's memory of rules in insufficient (Pfiffner & Barkley, 1990). Punishment and rewards are part of every classroom. Classroom management often is inconsistent and ineffective in classrooms. To be effective, punishments and rewards must be immediate, rewards must be pleasant and punishments must

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97 be unpleasant, discipline must be consistent, and discipline must be understood by the student (Stevens, 1997) Behavioral Behavior management is one of the most effective methods of treating children's school-related ADHD behavior problems (Dowdy, Patton, Smith, & Polloway, 1998; Power, Hess, & Bennett, 1995). Parents also view behavioral intervention as more socially acceptable than medication (Liu, Robin, Brenner, & Eastman, 1991). Teachers can help students stay on task and control their physical behaviors with positive behavior management techniques. The focus is to maintain or increase a child's appropriate behaviors (e.g raising hand before speaking), and decrease inappropriate behaviors (e.g., being off task). With the exception of stimulant medication, token reinforcement and response cost are the most widely studied classroom-based treatments (DuPaul, Eckert, & McGoey, 1997). Token economies are effective ways of implementing positive reinforcements in schools (Abramowitz & O'Leary, 1991; Jones & Jones, 1995). Token economy systems can improve both the academic (Allyon, Layman, & Kandel, 1975) and behavioral (Dowdy et al., 1998; Rosenberg, 1986) functioning of children with ADHD. Eight steps have been

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98 identified in the implementation of a token economy system (Wood, 1984): teacher identifies target behavior, teacher clearly identifies for the student if the behavior will earn tokens, teacher posts appropriate behavior on a chart or on student's desk, teacher and student select reinforcers to exchange for tokens, teacher explains rules of token system to student, teacher asks student to explain system, teacher initiate token system, and teacher evaluates token system. An advantage of this approach is that a teacher can utilize it with more than one student, using different target behaviors and reinforcers for each student (Dawson, 1995) Powerful negative consequences such as response-cost programs may be necessary for some children with ADHD (Pfiffner & Barkley, 1990; Wodrich, 1994). Mild punishment (e.g., loss of points or privileges) is applied when negative behavior is displayed. These programs also help to decrease symptoms of impulsivity (Bender & Mathes, 1995; Cocciarella, Wood, & Low, 1995) and to increase attention and work completion (Dawson, 1995). Response cost is particularly effective when combined with medication (Fiore, Becker, & Nero, 1993).

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99 Cognitive-behavioral therapy Cognitive-behavioral interventions have demonstrated success is several studies (Barkley, 1990; Williams & Mennuti, 1997). This therapy combines the behavioral management approach with a cognitive approach that involves problem solving, self-instruction, and self-monitoring. Increased self-awareness and active participation are the underlying principles. The approach assists children with ADHD to recognize, confront, and cope with their problems by providing them with a structured approach to tackle problems and reduce their impulsivity. Positive self-statements can be used to solve problems. Children are offered a structured and systematic process to approach problems (Fouse & Brians, 1993). The goal is an internalization of problem-solving steps, thus leading to self-instruction when a problem arises. Self-monitoring is easy to use and has been shown to increase on-task behavior (Dawson, 1995). This approach increases students awareness of their attending behavior. Typically, an audio tape is played, sounding electronic tones at random intervals (approximately 15-90 seconds apart). Each time the tone sounds, students are asked to

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note their attending behavior on a checklist. Self monitoring audio tapes may also be used at home. Cognitive-behavioral therapy offers a structured and systematic process for approaching problems. Parental and teacher guidance, modeling, and positive support allow children with ADHD to learn how to self-instruct. The process is effective for academic, social, and behavioral problems. Psychological 100 Psychological counseling may be helpful for individuals experiencing emotional problems. Like their peers, children and adolescents with ADHD experience the same self-doubts, conflicts, and worries, probably more frequently because of their history of failure and sense of lack of control (Wodrich, 1994). While it should not be the primary treatment modality, counseling is useful in addressing secondary or comorbid symptomatology (Quinn, 1997). It may be helpful since the disorder can negatively affect nearly every aspect of their lives, including family and peer relationship and learning. This is especially true for younger children who may have not yet developed many of the coping mechanisms essential for dealing with stresses in their lives (Nussbaum & Bigler, 1990).

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101 Counseling also may include involvement by the parents. Pediatric counseling centers on helping adolescents and parents achieve goal changes aimed at improving their current and later outcomes (Coleman & Levine, 1988). Counseling should incorporate several elements (Coleman & Levine, 1988): (1) allowing the family to ventilate their feelings; (2) providing specific advice regarding management at school, at home, and in the community; (3) helping the family to develop its own resources; (4) preventing self criticism and reducing parental guilt; (5) making referrals when necessary; (6) providing anticipatory guidance; and (7) serving as an advocate for the adolescent. Counseling can be provided by a school counselor or school psychologist, or a community-based mental health counselor. Support Personnel Support personnel (i.e., peer tutor) can provide many of the instructional variables considered important in helping children with ADHD succeed (Brock, 1998). This can have positive results with proper training (Osguthorpe & Scruggs, 1986). Peer tutoring is effective for children with ADHD as it incorporates active responding to academic material under conditions of frequent, immediate feedback (DuPaul & Stoner, 1994). By giving students a chance to

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102 observe and practice positive behaviors of their peer tutor, learning can generalize to other settings (e.g., lunchroom, playground) (Abramowitz & Slavin, 1991). It also may help the child practice previously-learned social skills. Home-based Interventions Interventions also may be implemented outside the classroom setting. Home-based interventions provide children with additional resources with which they can use to help control their ADHD symptoms. These interventions include parent training and counseling. Home-based Interventions Interventions also may be implemented outside the classroom setting. Home-based interventions provide children with additional resources with which they can use to help control their ADHD symptoms. These interventions include parent training and counseling. Parent training Instructing parents of children with ADHD in behavior management strategies can provide them with the skills necessary to enhance their children's attention to household tasks and rules (DuPaul & Stoner, 1994). Parents often have the greatest investment in eliciting positive behavior change in their children, including the best chance to

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103 manipulate the environment to help bring about this change Newby, Fischer, & Roman, 1991). A ten step parent training program has been developed to address the core problems related to ADHD (Figure 2) (Anastopoulos & Barkley, 1990). Each weekly session includes a review of information from the previous week, an assessment to determine if critical events occurred since the last meeting, and a discussion of the homework assigned the week before. The first step gives an overview of ADHD It provides parents with information in reference to the characteristics, prevalence, etiologies, and treatments of ADHD. They are asked to state their expectations for treatment, since these expectations often are unrealistic. Parents' faulty perceptions about themselves and their children also are addressed. The second step provides parents with a four-factor model for understanding deviant child behavior. Parents also obtain additional knowledge of behavior management for children with ADHD. Antecedents events and consequences are discussed, including how they can be altered to modify children's behavior. Parents are asked to complete an assignment which includes a profile of the child's

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Step 1 Program Orientation and Review of ADHD T Step 2 Understanding Parent-Child Relations and Principles of Behavior Management T Step 3 Enhancing Parental Attending Skills T Step 4 Paying Positive Attention to Appropriately Independent Play and Compliance; Giving Commands More Effectively T Step 5 Establishing a Home Token System T Step 6 Review of Home Token System; Using Response Cost T Step 7 Using Time-Out From Reinforcement T Step 8 Extending Time Out to Other Misbehavior; Managing Children's Behavior in Public Places T Step 9 Handling Future B~havior Problems T Step 10 Booster Session 104 Figure 2. Parent Training Program (Anastopoulos & Barkley, 1990).

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105 characteristics, a profile of their own characteristics and an inventory of family stresses. The third step begins to teach parents positive attending and ignoring skills in the context of special playtime exercises. "Special times" are introduced, and parents are instructed to remain nondirective and noncorrective when interacting with their children. Children are allowed to choose a desired activity, and parents are taught to refrain from asking the child too many questions and to avoid suggesting alternative play or interaction approaches. The fourth step includes three new objectives Parent and child reactions to special time are discussed, including the possibility of refinement for future use. Positive attending skills to appropriate independent play should be extended. If parents are comfortable with positive attending strategies, they are taught to expand them for use in other situations. Positive attending skills may be applied to parental command situations, and parents are taught more effective methods of communicating commands to children. The fifth step includes the establishment of a home token system. The reward system provides children with the motivation necessary to complete parental requests that may

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be of little intrinsic value. This system is used because positive attending and ignoring strategies often are insufficient for managing children with ADHD, since they generally require concrete and meaningful rewards. The sixth step involves the refinement of the home token system. Response cost strategies are discussed for minor noncompliance. Parental efforts to implement the system are reviewed, and suggestions for increasing its effectiveness are offered. 106 The seventh step offers information on the use of time out strategies for dealing with more serious forms of child noncompliance Parents are encouraged to identify one or two resistant types of noncompliance that may become the targets of time-out. Since this technique is difficult to employ, attention is focused on the mechanics of implementing the time-out procedure. The eighth step begins to extend parental use of time out to other problem areas. Focus and use of the home-based program are expanded to other settings. Parents start generalizing their newly acquired skills to problematic settings outside the home (e.g., department stores, grocery stores, restaurants).

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107 The ninth step involves eliciting parental feedback about the training program. Parents discuss areas in which they feel they will have future problems. They also are encouraged to think how they might handle these situations. The tenth step is considered a booster session and occurs approximately one month after the previous step. Rating scales and questionnaires are readministered to detect any posttreatment. A review and refinement of previously learned intervention strategies is conducted. Purpose of the Study A number of treatments currently are used for children with ADHD. Traditionally treatments include the administration of a prescription stimulant medication (e.g., Ritalin, Cylert, Dexedrine). While this treatment reportedly is effective in approximately 70 to 80% of the cases (Buncher, 1996), many parents object to their children being placed on medication at a young age, especially because of possible adverse or dangerous reactions. In addition, the United States Drug Enforcement Administration (DEA) has expressed alarm at the increase in the number of prescriptions for these drugs in recent years (Haislip, 1996).

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108 Complementary and alternative medicine has become very popular in the United States (Jonas, 1997). Many alternative approaches to the treatment of ADHD have been offered without any scientific evidence as to their effectiveness. The purpose of this study was to investigate the efficacy of the use of a dietary supplement combination (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, and L-Glutamine) and an essential fatty acid (i.e., flax seed) as a treatment for qualities relevant to ADHD (i.e., inattentiveness, hyperactivity-impulsivity). Its goal was to provide empirical evidence regarding their effectiveness in reducing ADHD-related behaviors in children diagnosed with this disorder.

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CHAPTER THREE METHODOLOGY Prior to the identification and selection of participants, a research protocol (Appendix A) and fact sheet (Appendix B) were prepared for submission to the Orlando Regional Healthcare System Institutional Review Board (ORHSIRB). Approval was granted by the both the ORHSIRB (Appendix C) and the University of Florida Institutional Review Board (Appendix D). Participants were children identified as meeting the DSM-IV criteria for a diagnosis of ADHD, Combined Type (Table 5). Their disorder was diagnosed by a physician or psychologist. Fifty-one (44 males and 7 females) of the 60 children originally selected to participate remained throughout the study (Table 6). They ranged in age from 4 to 12, with an average age of 8.4 years. Twenty-six (51%) of these children, 23 males and 3 females, were taking the stimulant medication Ritalin. 109

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Table 5 DSM-IV Criteria for a Diagnosis of ADHD, Combined Type A diagnosis of Attention-Deficit/Hyperactivity Disorder, Combined Type is given if both Criteria Al and A2 are met for the past 6 months. A. Either (1) or (2): (1) six (or more) of the following symptoms of inattention have persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level: Inattention: 110 (a) often fails to give close attention to details or makes careless mistakes in schoolwork, work, or other activities (b) often has difficulty sustaining attention in tasks or play activities (c) often does not seem to listen when spoken to directly (d) often does not follow through on instructions and fails to finish schoolwork, chores, or duties in the workplace (not due to oppositional behavior or failure to understand instructions) (e) often has difficulty organizing tasks and activities (f) often avoids, dislikes, or is reluctant to engage in tasks that require sustained mental effort such as schoolwork or homework) (g) often loses things necessary for tasks or activities (e.g., toys, school assignments, pencils books, or tools) (h) is often easily distracted by extraneous stimuli (i) is often forgetful in daily activities (2) six (or more) of the following symptoms of hyperactivity-impulsivity have persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level:

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111 Table 5--continued Hyperactivity: (a) often fidgets with hands or feet or squirms in seat (b) often leaves seat in classroom or in other situations in which remaining seated is expected (c) often runs about or climbs excessively in situations in which it is inappropriate (in adolescents and adults, may be limited to subjective feelings of restlessness) (d) often has difficulty playing or engaging in leisure activities quietly (e) is often "on the go" or often acts as it "driven by a motor" (f) often talks excessively Impulsivity: (g) often blurts out answers before the questions have been completed (h) often has difficulty awaiting turn (i) often interrupts or intrudes on others (e.g., butts into conversations or games) B. Some hyperactive-impulsive or inattentive symptoms that caused impairment were present before age 7 years. C. Some impairment from the symptoms is present in two or more settings (e.g., at school or work and at home). D. There must be clear evidence of clinically significant impairment in social, academic, or occupational functioning. E. The symptoms do not occur exclusively during the course of a Pervasive Developmental Disorder, Schizophrenia, or other Psychotic Disorder and are not better accounted for by another mental disorder (e.g., Mood Disorder, Anxiety Disorder, Dissociative Disorder, or a Personality Disorder). Source: American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.), pp. 83-85. Washington, D. C.: Author.

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Table 6 Participants by Assignment, Age Group, and Gender After Attrition (N = 51) Non-Ritalin Ritalin (N = 25) (N = 26) Age Group Male Female Male Female 3-5 years 4 0 1 1 6-8 years 8 2 10 2 9-11 years 9 0 9 1 12-14 years 1 1 2 0 Total 22 3 22 4 Selection of Participants 112 Participants were self-referred or referred by pediatricians, psychologists, psychiatrists, or educators. At the commencement of the study, parents of candidates completed a Study Participant Information Form (Appendix E), to obtain information in the following areas: birth, development, child's medical history, primary caregivers, child care, family history, brothers/sisters, participant's residence, family medical and psychiatric history, medical care, nutritional history, behavior temperament, educational history, social history, recreation/interests, mental health

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113 counseling, legal issues, and abuse/trauma. Information from this initial screening assisted in identifying children who were eligible for the study. They had to meet the DSM-IV criteria for ADHD, Combined Type. Those candidates with serious medical or psychological pre-existing condition (e.g., asthma, depression) were not considered. Candidates taking a stimulant medication other than Ritalin also were not considered for the study. A meeting was held with parents to explain in detail the purposes of the study and implementation procedures. This meeting was attended by all members of the study team: Amid Habib, M.D., Ronald Lynch, M.D., Robert Evans, Ph.D., Donna Johnston, N.D., C.H., and Bonnie Snyder, M.S., Ed.S. A parent of each prospective participant was required to attend the meeting; candidates were excluded from participating if a parent did not attend. Parents were informed of the requirements for, and reasons for refusal from, their child's participation in the study. They also were told they could withdraw their child from the study at any time. Parents were asked to notify the physician in charge of the study if their child's Ritalin dosage was modified or if medication was changed from Ritalin to any other medication to treat ADHD. These were causes for an

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114 administrative withdrawal of a child from the study. Nine children were withdrawn from the study during Trial I The reasons for withdrawal were: parental choice (n = 6), change in Ritalin dosage (n = 1), and participants stopped taking Ritalin (n = 2). Parents of participants signed a consent form (Appendix F) permitting them to participate in the study. Procedures Sixty candidates were chosen to participate. Thirty participants were randomly chosen from those not taking Ritalin, and thirty participants were randomly chosen from those taking Ritalin. The record of each participant was reviewed by Ronald Lynch, M.D. Parents of children whose primary care physician were treating them were asked to request a blood analysis (e.g., complete blood count, urinalyses, and lead levels) and to provide a copy of their child's last physical examination. Procedures completed within the previous 12 months were acceptable. All participants taking Ritalin continued to take it as prescribed by their physician. Participants' parents were asked to complete a Conners' Parent Rating Scale-Revised: Long Form (Conners, 1997a). If a child had two parents, they were asked to complete the

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115 measure together. Each child had a parent measure from each of three data collection periods. Parents of 51 participants completed this measure for all three periods (Table 7). The teacher with whom each participant spent most of their school day was asked to complete a Conners' Teacher Rating Scale-Revised: Long Form (Conners, 1997a). Parents of 51 participants completed this measure for all three periods (Table 7). The Conners' Rating Scales-Revised: Long Form (CRS-R:L) were chosen over other instruments, such as the Child Behavior Checklist (Achenbach, 1991a) and Teacher's Report Form (Achenbach, 1991b), because items from the DSM IV: Inattentive (Table 8) and DSM: Hyperactive-Impulsive Table 7 Parent and Teacher Data Collection, by Participants' Age Group and Gender Parent Data Teacher Data (N = 51) (N = 43) Age Group Male Female Male Female 3-5 years 5 1 5 0 6-8 years 18 4 17 4 9-11 years 18 1 13 0 12-14 years 3 1 3 1 Total 44 7 38 5

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116 Table 8 DSM-IV: Inattentive Subscale Items from the CRS-R:L Parent Version (9 items): 1. Avoids, expresses reluctance about, or has difficulties engaging in tasks that require sustained mental effort (such as schoolwork or homework). 2. Has difficulty sustaining attention in tasks or play activities. 3. Does not seem to listen to what is being said to him/her. 4. Does not follow through on instructions and fails to finish schoolwork, chores or duties in the workplace (not due to oppositional behavior or failure to understand instructions). 5. Has difficulty organizing tasks or activities. 6. Fails to give close attention to details or makes careless mistakes in schoolwork, work, or other activities. 7. Forgetful in daily activities. 8. Loses things necessary for tasks or activities (e.g., school assignments, pencils, books, tools, or toys). 9. Easily distracted by extraneous stimuli. Teacher Version (9 items): 1. Forgets things he/she has already learned. 2. Fails to give close attention to details or makes careless mistakes in schoolwork, work, or other activities. 3. Avoids, expresses reluctance about, or has difficulties engaging in tasks that require sustained mental effort (such as schoolwork or homework). 4. Does not seem to listen to what is being said to him/her. 5. Has difficulty organizing tasks or activities. 6. Has difficulty sustaining attention in tasks or play activities. 7. Loses things necessary for tasks or activities (e.g., school assignments, pencils, books, tools, or toys). 8. Does not follow through on instructions and fails to finish schoolwork (not due to oppositional behavior or failure to understand instructions). 9. Easily distracted by extraneous stimuli.

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117 (Table 9) symptoms subscales parallel DSM-IV criteria for a diagnosis of ADHD. That is, items match the core features of the disorder Conners (1997b) notes: A two-factor model (one factor for the nine attentive items and the other factor for the 9 hyperactive impulsive items) was found to have an excellent fit to the data for both parent and teacher ratings. In addition, the two-factor model was also found to have a good fit for males and females across age groups. (p. 96) Instrumentation The Conners' Rating Scales-Revised: Long Form (Conners, 1997a) were used to assess qualities relevant to ADHD. Information regarding each participant's inattentive, hyperactive, and impulsive behaviors was collected from parents and teachers using this measure. The Conners' Rating Scales assess a broad range of psychopathology and problem behaviors as identified by parents and teachers. The 80-item form for parents (CPRS R:L) includes the following scales and indices: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious-Shy, Perfectionism, Social Problems, Psychosomatic, Conners' ADHD Index, Conners' Global Index: Restless Impulsive, Conners' Global Index: Emotional Lability, Conners' Global Index: Total, DSM-IV: Inattentive, DSM-IV: Hyperactive-Impulsive, and DSM-IV: Total. The 59-item form

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Table 9 DSM-IV: Hyperactive-Impulsive Subscale Items from the CRS-R:L Parent Version (9 items): 1. Is always "on the go" or acts as if driven by a motor. 118 2. Runs about or climbs excessively in situations where it is inappropriate. 3. Talks excessively. 4. Has difficulty waiting in lines or awaiting turn in games or group situations. 5. Interrupts or intrudes on others (e.g., butts into others' conversation or games). 6. Fidgets with hands or feet or squirms in seat. 7. Has difficulty playing or engaging in leisure activities quietly. 8. Leaves seat in classroom or in other situations in which remaining seated is expected. 9. Blurts out answers to questions before the questions have been completed. Teacher Version (9 items): 1. Is always "on the go" or acts as if driven by a motor. 2. Leaves seat in classroom or in other situations in which remaining seated is expected. 3. Has difficulty waiting his/her turn. 4. Talks excessively. 5. Runs about or climbs excessively in situations where it is inappropriate. 6. Has difficulty playing or engaging in leisure activities quietly. 7. Fidgets with hands or feet or squirms in seat 8. Blurts out answers to questions before the questions have been completed. 9. Interrupts or intrudes on others (e.g., butts into others' conversation or games).

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119 for teachers (CTRS-R:L) includes the following scales and indices: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious-Shy, Perfectionism, Social Problems, Conners' ADHD Index, Conners' Global Index: Restless Impulsive, Conners' Global Index: Emotional Lability, Conners' Global Index: Total, DSM-IV: Inattentive, DSM-IV: Hyperactive-Impulsive, and DSM-IV: Total. The Conners' Rating Scales were administered prior to commencement of the study and after Trials I and II to assess treatment effects. For the purposes of this study, the two dependent variables are the DSM-IV: Inattentive as well as the DSM-IV: Hyperactive-Impulsive symptoms subscales. High T-scores (e.g., two standard deviations above the mean) on the DSM-IV: Inattentive subscale generally reflect children with DSM-IV diagnostic criteria that indicate Inattentive type ADHD. High T-scores (e.g., two standard deviations above the mean) on the DSM-IV: Hyperactive-Impulsive subscale generally reflect children with DSM-IV diagnostic criteria that indicate Hyperactive Impulsive type ADHD. Normative Data A normative sample of 2,482 children and adolescents (1,235 males and 1,247 females) between ages 3 and 17 was

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120 used for the Conners' Parent Rating Scale-Revised: Long Form (Conners, 1997b). Of those parents reporting their ethnicity, 83% identified themselves as Caucasian/White, 4.8% as African American/Black, 3.5% as Hispanic, 2.2% as Asian American, 1.1% as Native American, and 4.9% as Other or provided no information. A normative sample of 1,973 children and adolescents (965 males and 1,008 females) between ages 3 and 17 was used for the Conners' Teacher Rating Scale-Revised: Long Form. Of those teachers reporting their ethnicity, 78% identified themselves as Caucasian/White, 10.2% as African American/Black, 5.8% as Hispanic, 1.6 % as Asian American, 1.5% as Native American, and 2.8% as Other or provided no information. Validity The correlation between parent and teacher ratings on the two dependent variables is moderate and significant. The correlation is 47 for the DSM-IV: Inattentive subscale, and .36 for the DSM-IV: Hyperactive-Impulsive subscale (Conners, 1997b). For the Conners' Parent Rating Scale-Revised: Long Form, the intercorrelation between the DSM-IV: Inattentive and DSM-IV: Hyperactive-Impulsive subscales is .66 for males and .64 for females (Conners, 1997b) For the Conners

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121 Teacher Rating Scale-Revised: Long Form, the intercorrelation between the DSM-IV: Inattentive and DSM-IV: Hyperactive-Impulsive subscales is .71 for males and .59 for females (Conners, 1997b). The Conners' Rating Scales differentiates well between ADHD and non-ADHD students. Both the DSM-IV: Inattentive and DSM-IV: Hyperactive-Impulsive subscales were significant
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Table 10 Psychometric Properties of the CRS-R : L Internal Reliability Coefficients CPRS-R:L CTRS-R:L Subscale Male Female Male Female DSM-IV : Inattentive .93 .92 .95 .94 DSM-IV: HyperactiveImpulsive .90 .88 .94 .90 Test-Retest Reliability Coefficients (6-8 Weeks) Subscale DSM-IV: Inattentive DSM-IV: Hyperactive Impulsive CPRS-R:L .67 .81 CTRS-R:L .70 .47 122 be present, and changes that may occur between the first and subsequent administrations. Test-retest reliability for the three dependent variables ranges from .67 to .81 for parents, and from 47 to .70 for teachers (Conners, 1997b). A summary of test-retest reliability coefficients is provided in Table 10.

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Assignment of Participants The study consisted of two 12-week trials, hereafter called Trial I and Trial II. Within each trial were two experimental and two control groups. 123 A previously noted, sixty candidates initially were chosen to participate. Thirty participants were chosen randomly from those not taking Ritalin, and thirty participants were chosen randomly from those taking Ritalin. Participants were assigned randomly to either an experimental or control group prior to Trial I, and distributed evenly with 15 participants in each of four groups. Participants identified as not taking Ritalin were assigned to either non-Ritalin treatment group lA or non Ritalin control group lB; those participants identified as taking Ritalin were assigned to either Ritalin treatment group 2A or Ritalin control group 2B. Fifty-one children remained with the study until it ended (i.e., they completed both trials); data from dropout participants were deleted from the database. The number and mean age of participants in each group after attrition is displayed in Table 11.

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Table 11 Number and Mean Age of Participants in Each Group After Attrition Parent Data Teacher Data Group N Mean Age N Mean Age lA 13 7.8 11 7.6 lB 12 8.5 10 8.5 2A 12 8.3 9 8.4 2B 14 9.0 12 8.8 Treatments This was a single-blind study wherein parents, 124 teachers, and data collectors did not know what substances the participants were taking until the study was completed. Only the study physician had access to this information. Upon commencement of Trial I, participants in the treatment groups began taking their dietary supplement combination (Figure 3). This combination consisted of: Ginkgo biloba 10 mg, Melissa officinalis 200 mg, Grapine 30 mg, dimethylaminoethanol 35 mg, and L-Glutamine 100 mg. For those not taking Ritalin, participants in Group lA received a dietary supplement combination, while participants in Trial lB received a placebo. Participants already taking

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125 Trial & Treatment Group Treatment Ingredients & Dosages Trial I, Dietary Ginkgo biloba 10 mg; Melissa Group lA supplement officinalis 200 mg; Grapine (Treatment) combination 30 mg; dimethylaminoethanol 35 mg; L-Glutamine 100 mg Trial I, Placebo Slippery elm supplement 220 Group 1B mg (Control) Trial I, Ritalin plus Ginkgo biloba 10 mg; Melissa Group 2A dietary officinalis 200 mg; Grapine (Treatment) supplement 30 mg; dimethylaminoethanol combination 35 mg; L-Glutamine 100 mg Trial I, Ritalin plus Slippery elm supplement 220 Group 2B placebo mg (Control) Trial II, Double dietary Ginkgo biloba 20 mg; Melissa Group lA supplement officinalis 400 mg; Grapine (Control) combination 60 mg; dimethylaminoethanol 70 mg; L-Glutamine 200 mg Trial II, Double dietary Ginkgo biloba 20 mg; Melissa Group 1B supplement officinalis 400 mg; Grapine (Treatment) combination 60 mg; dimethylaminoethanol with an 70 mg; L-Glutamine 200 mg; essential fatty flax seed 1,000 mg acid Trial II, Ritalin plus Ginkgo biloba 20 mg; Melissa Group 2A double dietary officinalis 400 mg; Grapine (Control) supplement 60 mg; dimethylaminoethanol combination 70 mg; L-Glutamine 200 mg Trial II, Ritalin plus Ginkgo biloba 20 mg; Melissa Group 2B double dietary officinalis 400 mg; Grapine (Treatment) supplement 60 mg; dimethylaminoethanol combination 70 mg; L-Glutamine 200 mg; with an flax seed 1,000 mg essential fatty acid Figure 3. Treatment during Trials I and II

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126 Ritalin were instructed to take it in addition to their study medication. Participants in Group 2A received a dietary supplement combination in addition to their Ritalin, while participants in Group 2B received a placebo in addition to their Ritalin. Trial II was implemented following the completion of Trial I (i.e., after 12 weeks), using the same subjects from the first trial. Subjects remained in their cohort group; only the treatment changed. All participants received a double dietary supplement combination whose concentration was doubled (i.e., the dosage of each ingredient was doubled). The initial lower concentration was used during Trial I since it is best to begin on a lower herbal dose and increase it only if improvements are not demonstrated (Dillard & Ziporyn, 1998). Anecdotal reports from parents to the study physician led to a decision to double the concentration of each ingredient in the dietary supplement during Trial II. The two treatment groups received an essential fatty acid with their combination. The double dietary supplement combination, a uniform intervention, helped to detect significant differences in levels of

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127 inattentiveness and hyperactivity-impulsivity displayed by participants in the groups receiving an essential fatty acid. For those not taking Ritalin, participants in Group lA (that first received the dietary supplement combination) now received a double dietary supplement combination. Participants in Group 1B (that first received a placebo) now received a double dietary supplement combination with an essential fatty acid. For those already taking Ritalin, participants in Group 2A (that first received the dietary supplement combination) now received a double dietary supplement combination. Participants in Group 2B (that first received a placebo) now received a double dietary supplement combination with an essential fatty acid. A slippery elm supplement was used as the placebo. It is rich in vitamins and minerals and has a long history of use as a food supplement, especially by pioneers who considered it "survival food" (Percival, 1994). It was chosen for this study since it has been declared safe by the Food and Drug Administration (Tyler, 1994). Slippery elm also tastes similar to other herbal or nutritional supplements.

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128 Administration The dietary supplement combination, double dietary supplement combination, and double dietary supplement combination with an essential fatty acid, and slippery elm placebo were in capsule form. Donna Johnston, a Doctor of Naturopathy mailed supplements to the parent of each participant prior to the beginning of each trial The supplements were prepared and provided at no cost by Nature's Sunshine Products in Provo, Utah This was a single-blind study wherein parents, teachers, and data collectors did not know what substances the participants were taking until the study was completed. Only the study physician had access to this information. Ritalin was ingested in tablet form. Participants taking this medication were instructed to continue taking it as prescribed by their physician. Parents were asked to notify the study physician, Amid Habib, M.D., if their child's medication or medication dosage changed. At the beginning of each trial, participants were instructed to take their treatment medication (i e., dietary supplement combination, double dietary supplement combination, double dietary supplement combination with an essential fatty acid, or placebo) twice daily, once with

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129 breakfast and again with an afternoon snack or with dinner. Although no adverse reactions were anticipated from ingestion of the treatment medication, participants were instructed to immediately contact Dr. Habib should any adverse reactions occur. As previously noted, one participant was withdrawn from the study due to a change in Ritalin dosage, while two participants were withdrawn because they stopped taking Ritalin. Trial I Hypotheses Hypothesis 1: Participants receiving the dietary supplement combination (i.e., Group lA) were expected to display less inattentiveness than those receiving the placebo (i.e., Group lB), based on parent and teacher reports. A decrement in inattentive behaviors was expected as a result of ingesting Ginkgo biloba, Grapine, dimethylaminoethanol, and L-Glutamine from the dietary supplement combination. Hypothesis 2: Participants receiving Ritalin plus the dietary supplement combination (i.e., Group 2A) were expected to display less inattentiveness than those receiving Ritalin plus the placebo (i.e., Group 2B), based on parent and teacher reports. A decrement in inattentive behaviors was expected as a result of ingesting Ginkgo

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130 biloba, Grapine, dimethylaminoethanol, and L-Glutamine from the dietary supplement combination. Hypothesis 3: Participants receiving the dietary supplement combination (i.e., Group lA) were expected to display less hyperactivity-impulsivity than those receiving the placebo (i.e., Group lB), based on parent and teacher reports. A decrement in hyperactive-impulsive behaviors was expected as a result of ingesting Melissa officinalis and Grapine from the dietary supplement combination. Hypothesis 4: Participants receiving Ritalin plus the dietary supplement combination (i.e., Group 2A) were expected to display less hyperactivity-impulsivity than those receiving Ritalin plus the placebo (i.e., Group 2B), based on parent and teacher reports. A decrement in hyperactive-impulsive behaviors was expected as a result of ingesting Melissa officinalis and Grapine from the dietary supplement combination. Trial II Hypotheses Hypothesis 1: Participants receiving the double dietary supplement combination with an essential fatty acid (i.e., Group lB) were expected to display less inattentiveness than those receiving the double dietary supplement combination (i.e., Group lA), based on parent and teacher reports. A

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131 decrement in inattentive behaviors was expected as a result of ingesting Ginkgo biloba, Grapine, dimethylaminoethanol, L-Glutamine, and flaxseed (i.e., the double dietary supplement combination with an essential fatty acid). Hypothesis 2: Participants receiving Ritalin plus the double dietary supplement combination with an essential fatty acid (i.e., Group 2B) were expected to display less inattentiveness than those receiving Ritalin plus the double dietary supplement combination (i.e., Group 2A), based on parent and teacher reports. A decrement in inattentive behaviors was expected as a result of ingesting Ginkgo biloba, Grapine, dimethylaminoethanol, L-Glutamine, and flaxseed (i.e the double dietary supplement combination with an essential fatty acid) Hypothesis 3: Participants receiving the double dietary supplement combination with an essential fatty acid (i.e., Group lB) were expected to display less hyperactivity impulsivity than those receiving the double dietary supplement combination (i e., Group lA), based on parent and teacher reports. A decrement in hyperactive-impulsive behaviors was expected as a result of ingesting Melissa officinalis, Grapine, and flaxseed (i.e., the double dietary supplement combination with an essential fatty acid).

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132 Hypothesis 4: Participants receiving Ritalin plus the double dietary supplement combination with an essential fatty acid (i.e., Group 2B) were expected to display less hyperactivity-impulsivity than those receiving Ritalin plus the double dietary supplement combination (i.e., Group 2A), based on parent and teacher reports. A decrement in hyperactive-impulsive behaviors was expected as a result of ingesting Melissa officinalis, Grapine, and flaxseed (i.e., the double dietary supplement combination with an essential fatty acid). Data Analysis Procedures The data were analyzed using analysis of covariance (ANCOVA). The method is used to compare data from two time periods when data from the first period may display group differences and be correlated with data from the second time period. ANCOVA adjusts data at time two based on data from time one. Thus, ANCOVA eliminates initial group differences on the covariate and increases precision. Pretest raw scores from the Conners' Rating Scales-Revised, children's age groups from the Conners' Rating Scales Revised, and gender were used as covariates. The rating scale does not use a child's actual age when calculating a raw score; rather, it uses five age groups (i.e., ages 3 to 5, ages 6 to 8, ages 9

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133 to 11, ages 12 to 14, and ages 15 to 17). Also, different criteria are used when determining a raw scores for males and females. The three covariates are appropriate because their values are indicators of a characteristic of the experimental units (i.e., posttest raw score) and the treatment in no way affected the value of these covariates, measured prior to applying treatments to the experimental units. Separate analyses were performed on Trial I and Trial II data. Posttest scores from Trial I were used as the covariate for Trial II. An alpha level of .05 was used for all statistical tests.

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CHAPTER FOUR ANALYSIS OF THE DATA Trial I Results Hypothesis 1: Participants receiving the dietary supplement combination (i.e., Group lA) were expected to display less inattentiveness than those receiving the placebo (i.e., Group lB), based on parent and teacher reports. Differences in parent reports of attentiveness between children receiving the dietary supplement combination (i.e., Group lA) and those receiving the placebo (i.e., Group lB) are not significant (E = .89) (Table 12). Also, differences in teacher reports of attentiveness between children receiving the dietary supplement combination (i.e., Group lA) and those receiving the placebo (i.e., Group lB) are not significant (E = .12) (Table 13). Results indicate that a dietary supplement combination had no measurable effect on the attentiveness of children not taking Ritalin as determined by both parent and teacher reports. 134

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135 Table 12 Trial I Parent Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin Pretest Treatment N M SD Dietary Supplement Combination 13 18.3 5.7 Placebo 12 16.0 5.5 (f = 89) Table 13 Posttest M SD 17.1 6.2 15.4 5.5 Adjusted Posttest M SE 17.2 1.8 16.9 1. 7 Trial I Teacher Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin Pretest Treatment N M SD Dietary Supplement Combination 11 14.2 6.7 Placebo 11 15.3 6.3 (f = .12) Posttest M SD 12.5 6.7 17.3 5.2 Adjusted Posttest M SE 13.8 2.0 17.7 1. 9

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136 Hypothesis 2: Participants receiving Ritalin plus the dietary supplement combination (i.e., Group 2A) were expected to display less inattentiveness than those receiving Ritalin plus the placebo (i.e., Group 2B), based on parent and teacher reports. Differences in parent reports of attentiveness between children receiving the dietary supplement combination (i.e., Group 2A) and those receiving the placebo (i.e., Group 2B) are not significant (f = .40) (Table 14). Also, differences in teacher reports of attentiveness between children Table 14 Trial I Parent Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin Pretest Treatment N M SD Dietary Supplement Combination 12 16.1 5.7 Placebo 14 19.0 5.5 (f = .40) Posttest M SD 15.8 6.0 15.8 7.8 Adjusted Posttest M SE 17.2 1. 7 15.3 1.8

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137 receiving the dietary supplement combination (i e Group 2A) and those receiving the placebo (i.e., Group 2B) are not significant (E = .29) (Table 15) Results indicate that a dietary supplement combination had no measurable effect on the attentiveness of children taking Ritalin as determined by both parent and teacher reports. Hypothesis 3: Participants receiving the dietary supplement combination (i.e., Group lA) were expected to display less hyperactivity-impulsivity than those receiving the placebo (i.e., Group lB), based on parent and teacher reports. Table 15 Trial I Teacher Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Dietary Supplement Combination 9 13.3 6.7 15.3 8.1 16 9 2.1 Placebo 12 17.3 6.4 14.8 5.5 14.2 2.0
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138 Differences in parent reports of hyperactivity impulsivity between children receiving the dietary supplement combination (i.e., Group lA) and those receiving the placebo are not significant (i.e., Group lB)
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139 Table 17 Trial I Teacher Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Not Taking Ritalin Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Dietary Supplement Combination 11 15.3 7.1 11.3 5.2 11.2 2.1 Placebo 11 13.1 9.1 11.5 7.9 12.4 2.0
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140 (Table 18). Also, differences in teacher reports of hyperactivity-impulsivity between children receiving the dietary supplement combination (i.e., Group 2A) and those receiving the placebo (i.e., Group 2B) are not significant (E = .71) (Table 19). Results indicate that a dietary supplement combination had no measurable effect on the hyperactivity-impulsivity of children taking Ritalin as determined by both parent and teacher reports. Table 18 Trial I Parent Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Taking Ritalin Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Ritalin Plus Dietary Supplement Combination 12 14.5 5.1 12.7 4.5 13.5 1.4 Ritalin Plus Placebo 14 18.1 6.7 14 7 8.1 13.3 1.5
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Table 19 Trial I Teacher Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Taking Ritalin 141 Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Ritalin Plus Dietary Supplement Combination 9 12.2 9.1 12.3 8.4 13.8 2.2 Ritalin Plus Placebo 12 16.0 6.0 15.3 6.1 14.8 2.0
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142 Group lA) are not significant
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143 Table 21 Trial II Teacher Results From the DSM-IV: Inattentive Subscale for Children Not Taking Ritalin Pretest Treatment N M SD Double Dietary Supplement Combination w/ an Essential Fatty Acid 11 17.3 5.2 Double Dietary Supplement Combination 11 12 5 6.7
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144 Differences in parent reports of attentiveness between children receiving Ritalin plus the double dietary supplement combination with an essential fatty acid (i.e., Group 2B) and those receiving Ritalin plus the double dietary supplement combination (i.e., Group 2A) are not significant (E = .60) (Table 22). Results indicate that Ritalin plus the double dietary supplement combination with an essential fatty acid had no measurable effect on the Table 22 Trial II Parent Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Ritalin Plus Double Dietary Supplement Combination w/ an Essential Fatty Acid 14 15.8 7.8 15.6 8.2 15.6 1.5 Ritalin Plus Double Dietary Supplement Combination 12 15.8 6.0 14.6 5.1 14.6 1.4 CE = 60)

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attentiveness of children taking Ritalin as determined by parent reports 145 Differences in teacher reports of attentiveness were found between children receiving Ritalin plus the double dietary supplement combination with an essential fatty acid (i.e., Group 2B) and those receiving Ritalin plus the double dietary supplement combination (i.e., Group 2A). Children taking Ritalin plus the double dietary supplement combination with an essential fatty acid displayed significantly less attentiveness than those taking Ritalin plus the double dietary supplement combination (E = .04) (Table 23). Hypothesis 3: Participants receiving the double dietary supplement combination with an essential fatty acid (i.e., Group 1B) are expected to display less hyperactivity impulsivity than those receiving the double dietary supplement combination (i.e., Group lA), based on parent and teacher reports. Differences in parent reports of hyperactivity impulsivity were found between children receiving the double dietary supplement combination with an essential fatty acid (i.e., Group 1B) and those receiving the double dietary supplement combination (i.e., Group lA). Children taking the

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Table 23 Trial II Teacher Results From the DSM-IV: Inattentive Subscale for Children Taking Ritalin 146 Pretest Posttest Adjusted Posttest Treatment N M SD M SD M Ritalin Plus Double Dietary Supplement Combination w/ an Essential Fatty Acid 12 14.8 5.5 14.8 6.1 16.3 Ritalin Plus Double Dietary Supplement Combination 9 15.3 8.1 11.0 6.2 12.2
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Table 24 Trial II Parent Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Not Taking Ritalin 147 Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Double Dietary Supplement Combination w/ an Essential Fatty Acid 12 13.8 7.7 9.5 6.0 9.4 1. 3 Double Dietary Supplement Combination 13 11. 8 5.3 11.3 6.1 13.1 1.3
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Table 25 Trial II Teacher Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Not Taking Ritalin 148 Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Double Dietary Supplement Combination w/ an Essential Fatty Acid 11 11.5 7.9 15.5 9.1 17.9 1. 7 Double Dietary Supplement Combination 11 11.3 5.2 10.3 6.7 13.4 1. 8
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149 Table 26 Trial II Parent Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Taking Ritalin Treatment N Ritalin Plus Double Dietary Supplement Combination w/ an Essential Fatty Acid 14 Ritalin Plus Double Dietary Supplement Combination 12 (f = .8691) Pretest Posttest M SD M SD 14.7 8.1 14.6 8.2 12.7 4.5 12.7 5.6 Adjusted Posttest M SE 13.7 1.3 13.5 1.3 children receiving Ritalin plus the double dietary supplement combination with an essential fatty acid (i.e., Group 2B) and those receiving Ritalin plus the double dietary supplement combination (i.e., Group 2A) are not significant (f = .50) (Table 27). Results indicate that Ritalin plus a double dietary supplement combination with an essential fatty acid had no measurable effect on the

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Table 27 Trial II Teacher Results From the DSM-IV: Hyperactive Impulsive Subscale for Children Taking Ritalin 150 Pretest Posttest Adjusted Posttest Treatment N M SD M SD M SE Ritalin Plus Double Dietary Supplement Combination w/ an Essential Fatty Acid 12 15.3 6.1 11.3 6.9 10.8 1. 7 Ritalin Plus Double Dietary Supplement Combination 9 12.3 8.4 10.3 7.0 12.3
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151 combined during each trial). Also, the behaviors of children receiving the dietary supplement combination (i.e Groups lA and 2A combined) were compared with those receiving a placebo (i.e Groups lB and 2B combined) during Trial I while the behaviors of children receiving the double dietary supplement combination with an essential fatty acid (i.e., Groups lB and 2B combined) were compared with those receiving the double dietary supplement combination with an essential fatty acid (i.e., Groups lA and 2A combined) during Trial II. Non-Ritalin vs. Ritalin Groups The inattentive and hyperactive-impulsive behaviors of children not taking Ritalin (i.e., Groups lA and lB combined) were compared with those taking Ritalin (i.e., Groups 2A and 2B combined) (Table 28). Results from Trial I indicate there are no significant differences in inattentiveness as observed by parents (E = .59) and teachers (E = .91) between those taking and not taking Ritalin. There also are no differences in hyperactivity impulsivity as observed by parents (E = .30) and teachers (E = 17) between these two groups Results from Trial II indicate there is no difference in inattentiveness between children taking and not taking

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152 Table 28 Ritalin vs. Non-Ritalin Group Comparisons for the DSM-IV: Inattentive and DSM-IV: Hyperactive-Impulsive Subscales Trial I (p-values) DSM-IV: Inattentive DSM-IV: Hyperactive Impulsive Parents Teachers Parents Teachers 59 .91 Trial II (p-values) DSM-IV: Inattentive .10 .04 30 .17 DSM-IV: Hyperactive Impulsive .05 .01 Ritalin as observed by parents
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153 Treatment vs. Control Groups The inattentive and hyperactive-impulsive behaviors of children in the treatment groups were compared with those in the control groups. During Trial I, behaviors of children taking the dietary supplement combination (i.e., Groups lA and 2A combined) were compared with those taking the placebo (i.e., Groups 1B and 2B combined) (Table 29). Results indicate there are no differences in inattentiveness as observed by parents (f = .48) and teachers (f = .73) between those in these two groups. There also are no differences in hyperactivity-impulsivity as observed by parents (f = .47) and teachers (f = .54) between these two groups. During Trial II, behaviors of children taking the double dietary supplement with an essential fatty acid (i.e., Groups 1B and 2B combined) were compared with those taking the double dietary supplement combination (i.e Groups lA and 2A combined) (Table 29). Results indicate teachers (f = .04) but not parents (f = .80) report group differences in inattentiveness. Children who received a double dietary supplement combination displayed less inattentiveness than those who received a double dietary supplement with an essential fatty acid. Finally, results also indicate there are no differences in hyperactivity

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154 Table 29 Treatment vs Control Group Comparisons for the DSM-IV : Inattentive and DSM-IV: Hyperactive-Impulsive Subscales Parents Teachers Parents Teachers Trial I (p-values) DSM-IV: Inattentive .48 .73 Trial II (p-values) DSM-IV: Inattentive 80 .01 DSM-IV: Hyperactive Impulsive .47 .54 DSM-IV : Hyperactive Impulsive .15 33 impulsivity as observed by parents (E = 15) and teachers (E = .33) between these two groups.

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CHAPTER FIVE DISCUSSION AND RECOMMENDATIONS Discussion of the Results Stimulant medications often are used to treat the symptoms of ADHD. Ritalin is widely used and is effective. Professionals and parents are concerned about adverse reactions from its use and therefore are looking for alternative treatments to combat ADHD symptoms. Complementary and alternative medicines (CAM) are believed to offer parents an opportunity to treat their children with ADHD without risking these adverse reactions. The popularity of CAM has grown in recent years. The use of CAM with children also is increasing (Spigelblatt, 1995). CAM includes practices requiring highly specialized and competent practitioners, over-the-counter products, and self-care techniques. Many patients use alternative medicine either because they are attracted to CAM philosophies and health beliefs or are dissatisfied with the process or results of their conventional care (Furnham & Forey, 1994). 155

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156 The choice of an alternative treatment often depends on its effectiveness, cost, and ease of use. For example, while empirical research has shown neurofeedback to be effective for children with ADHD, its initial high cost is a drawback for some parents. In contrast, herbal and nutritional supplements are readily available and inexpensive. Ingredients such as Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, L-Glutamine, and flaxseed have been used as holistic treatments for ADHD either individually or in combination with other ingredients. In Germany, Ginkgo biloba extracts are among the most widely used herbal medicines (Jones, 1998). Because the extract increases blood circulation to the brain and increase oxygen levels in brain tissues, it is used primarily in an effort to improve mental clarity and alertness (Hobbs, 1991). The treatment is somewhat effective for disorders of the brain, such as dementia and memory impairment ("Boost Brain Power," 1998; Itil & Martorano, 1995; Kanowski et al., 1996; LeBars et al., 1997; Oken et al., 1998; Pang et al., 1996; Rai et al., 1991; Soholm, 1998). In a review of 40 controlled trials, nearly all trials reported at least a partial positive outcome in patients with cerebral insufficiency (Kleijnen & Knipschild,

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157 1992). Cerebral insufficiency is a general term for a collection of symptoms that include difficulties of concentration and memory, absentmindedness, confusion, lack of energy, depressive mood, anxiety, dizziness, tinnitus, and headache. Melissa officinalis, or lemon balm, contains nervine principles that help restore the balance and function of the brain and nerve cells. It has a mild relaxing effect, making it a good treatment for children with hyperactivity (Anderson & Peiper, 1996; Klein, 1998; Mendola, 1996) and other symptoms related to ADHD (Bell & Peiper, 1997) Grapine is derived from both the bark of the French Maritime Pine tree and grape seed (Elkins, 1995). Children with ADHD have found grapine somewhat effective in decreasing their symptoms by normalizing brain function (Rapp, 1998; Weintraub, 1997). It is a high potency antioxidant known to cross the blood-brain barrier to facilitate the flow of oxygen to the brain and central nervous system, thereby improving inattentiveness and hyperactivity (Anderson & Peiper, 1996), as well as memory, recall, and concentration (Bell & Peiper, 1997). It often is used in France to control symptoms of ADHD. Many Americans

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158 are using it as an alternative to Ritalin as a treatment for ADHD (Debroitner & Hart, 1997). Dimethylaminoethanol (DMAE) is a choline precursor that easily crosses the blood-brain barrier. It normally is present in small quantities in our brains and is thought to improve memory and learning, intelligence, and to elevate moods (Weintraub, 1997). Seafood (e.g., sardines, anchovies) is naturally abundant in DMAE, supporting the notion that fish is good "brain food". A diet high in seafood will provide higher than average levels of DMAE and choline to the brain, ingredients that serve as raw materials for the production of the neurotransmitter acetylcholine. Acetylcholine is responsible for conducting nerve impulses within the brain. L-Glutamine is an amino acid that penetrates the barrier separating the brain from the rest of the body's circulatory system. It helps create the transmitters in the brain that enhances learning and memory, and has increase the IQs of mentally impaired children (Rogers & Pelton, 1957). Once inside the brain, it has the unusual ability to provide fuel for brain cells, thus improving mental alertness, and clarity of thinking and mood (Cocchi, 1976). Glutamine has been found to be deficient in children with

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159 ADHD (Sahley, 1997). Supplementation may help improve concentration, alertness, memory, and recall (Bell, 1997). Some children with ADHD have displayed an improvement in their symptoms after taking glutamine, and some believe glutamine and Ginkgo biloba are an effective combination that promotes concentration, memory, and on-task behavior (Sahley, 1997). Many children with ADHD cannot metabolize or absorb essential fatty acids normally (Colquhoun & Bunday, 1981). These acids are important energy-supplying molecules; about 20 specific fatty acids are required by the human body to maintain normal function (Weintraub, 1997). High concentrations of essential fatty acids are found in the brain and aid in the transmission of nerve impulses. Flaxseed, for example, is rich in omega-3 essential fatty acids (Balch & Balch, 1997). Essential fatty acids have been found in lower concentrations in the plasma polar lipids and in red blood cell total lipids of ADHD subjects (Stevens et al., 1995). A deficiency of essential fatty acids can contribute to a variety of physical changes, including an impaired ability to learn and recall information (Stevens et al., 1996) and learning disabilities (Lee, 1997). Essential fatty acid

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supplementation has been shown to improve problems with attention problems and motor excess as measured by the Revised Behavior Problem Checklist and performance tasks (Aman et al. 1987). Intervention Effects on Inattentiveness 160 The nutritional combination of Ginkgo biloba 10 mg, Melissa officinalis 200 mg, Grapine 30 mg, dimethylaminoethanol 35 mg, and L-Glutamine 100 mg was thought to ameliorate the inattentive behaviors exhibited by participants and thus was evaluated during Trial I. Results indicate this nutritional combination had no measurable effect on participant s inattentiveness for children taking and not taking Ritalin Ingestion of this combination of ingredients was hypothesized to result in a decrement in inattentiveness, given findings from several scholars (e g., Anderson & Peiper 1996; Cocchi, 1976 ; Kleijnen & Knipschild, 1992) who these ingredients improved attentiveness among children with ADHD Several reasons are offered to explain differences between the f i ndings from this study and those reported by others. Sample sizes from other studies are unknown Positive results from those studies may be attributed to

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161 only a few subjects chosen from those most likely to display an improvement. Information about whether reports of improvement are based on objective or subjective measures is unknown. For example, objective measures such as the use of rating scales or DSM criteria often are used with empirical research, whereas anecdotal evidence comes from parent and teacher reports. Reports of the effective use of alternative treatments often are not accompanied by information regarding whether results are based on empirical or anecdotal evidence. Thus, positive changes may be attributed to anecdotally-acquired rather than more stringent empirical evidence. The dosages used in studies reporting significant changes in inattentiveness are unknown. The choice of dosage of herbal supplements and dietary supplements remains somewhat arbitrary, especially for children. Lack of information regarding dosages used in studies with children with ADHD makes it difficult to compare dosages and interpret research findings. During Trial II, the double nutritional combination with an essential fatty acid consisted of Ginkgo biloba 20 mg, Melissa officinalis 400 mg, Grapine 60 mg,

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162 dimethylaminoethanol 70 mg, L-Glutamine 200 mg, and flax seed 1,000 mg. This combination was hypothesized to ameliorate inattentive behaviors exhibited by participants. Several scholars (e.g., Aman, Mitchell, & Turbott, 1987; Anderson & Peiper, 1996; Cocchi, 1976; Kleijnen & Knipschild, 1992) reported these ingredients improved attentive behaviors among children with ADHD. Results from Trial II were mixed. For children not taking Ritalin, differences in attentiveness between those receiving the double nutritional combination with an essential fatty acid and those receiving the double nutritional combination were not measurable. This is consistent with the results from Trial I. However, the results are unexpected given previous reports the ingredients in the double nutritional combination with an essential fatty acid helped ameliorate inattentiveness. For children taking Ritalin, differences in attentiveness based on parent reports were not measurable, but were measurable based on teacher reports. Children who received a double dietary supplement combination displayed less inattentiveness than those who received a double dietary supplement with an essential fatty acid.

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163 As previously mentioned, unknown sample sizes of other studies, information about whether other reports are based on empirical or anecdotal evidence, and dosages used in other studies are unknown. Also, not all essential fatty acids may work alike. It is possible that flaxseed, while high in omega-3 essential fatty acids, works differently than other essential fatty acids. Reports of positive responses to essential fatty acids often do not indicate which kind was used. Instead, the generic term "essential fatty acid" typically is reported, leaving the reader without knowledge regarding the type of supplement. Intervention Effects on Hyperactivity-Impulsivity During Trial I, the nutritional combination of Ginkgo biloba 10 mg, Melissa officinalis 200 mg, Grapine 30 mg, dimethylaminoethanol 35 mg, and L-Glutamine 100 mg was hypothesized to ameliorate the hyperactive-impulsive behaviors exhibited by participants. Two of the ingredients in the nutritional combination (i.e., Melissa officinalis and Grapine) have been shown to improve hyperactive impulsive behaviors (Anderson & Peiper, 1996; Klein, 1998; Mendola, 1996). Results from Trial I indicate that the nutritional combination had no measurable effect on participants'

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164 hyperactivity-impulsivity for children taking and not taking Ritalin. The ingestion of the combination was expected to result in a decrement in hyperactivity-impulsivity, given several reports (e.g., Anderson & Peiper, 1996; Klein, 1998; Mendola, 1996) describing the benefits of these ingredients improving attentiveness among children with ADHD. The double nutritional combination with an essential fatty acid used during Trial II consisted of Ginkgo biloba 20 mg, Melissa officinalis 400 mg, Grapine 60 mg, dimethylaminoethanol 70 mg, L-Glutamine 200 mg, and flax seed 1,000 mg. This combination was hypothesized to ameliorate inattentive behaviors exhibited by participants. Results from Trial II were mixed. Among children not taking Ritalin, measurable difference in hyperactivity impulsivity were noted from both parent and teacher reports. However, results are contradictory. Parents reported children who received the double dietary supplement combination with an essential fatty acid displayed significantly less hyperactive-impulsive behaviors than those receiving the double dietary supplement combination. Meanwhile, teachers reported children who received the double dietary supplement combination with an essential fatty acid displayed more hyperactive-impulsive behaviors

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than those receiving the double dietary supplement combination 165 Contradictory results may be attributed to the subjective nature of rating scales. Parents and teachers were asked to provides ratings of children's behavior based on observable behavior. For example, teacher ratings can be influenced by their experience with children of similar age and thus are familiar with age-appropriate behaviors (Kamphaus & Frick, 1996) Given the growing interest in complementary and alternative medicines such as dietary supplements together with an increasing number of children with ADHD, why are there not more empirical studies that assess their effectiveness? One reason may be attributed to lack of control over the quality of ingredients. A recent article in Consumer Reports, a leading consumer magazine, notes "today's supplements don't get as much government scrutiny as medicated cough drops" ("Herbal Rx," 1999, p. 45). The Dietary Supplement Health and Education Act of 1994 severely restricted the Food and Drug Administration's (FDA) authority over a product labeled a "supplement" unless it claims to affect diseases As such, manufacturers are not required to provide support for their claims of

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166 effectiveness, and a product from one manufacturer may be more effective than that of another. For example, Consumer Reports notes recent tests of Gingko biloba products showed variations in active ingredients ("Herbal Rx," 1999). With little information available on the effectiveness of ingredients, it can be difficult for researchers to develop a standard protocol given existing brand-to-brand variations. Positive results from such studies may be viewed as an endorsement for a particular brand rather than for the dietary supplement. Effort by the supplement industry to empirically test the effectiveness of its products in treating illnesses or support the research of others have been minimal. One would assume that positive findings would benefit the sale of supplements. Of course, it is possible that research has been completed and, failing to find support for the efficacy of supplements, either never has been published. Supporters of stimulant medications may be correct. If there is little empirical evidence that shows alternative treatments are effective in ameliorating inattentiveness and hyperactivity-impulsivity, then their use with children displaying these ADHD symptoms may be questionable.

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167 Study Limitations This study has a number of limitations. One shortcoming is the lack of knowledge regarding which of the ingredients in the dietary supplement combination resulted in treatment effects. While it was hypothesized that the combination would help to decrease the characteristics of ADHD, it is possible that only one or more of the ingredients may be responsible for treatment effects. A second shortcoming is the lack of information regarding additional medications taken by participants. Participants taking medication other than Ritalin were excluded from the study, but it is unknown whether participants ingested any other over-the-counter medications (e.g., antihistimines or a decongestant for the common cold) that may cause adverse reactions. For example, warning labels on packages of antihistimines and decongestants state the products may cause excitability in children. If participants were taking this medication when parents and teachers completed the Conners' Rating Scales-Revised, it is possible the ratings may have reflected behaviors associated with ingestion of the non-prescribed medication instead of those associated with the study. Thus, these medications have the potential to camouflage beneficial effects of the

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treatment intervention (i.e., double dietary supplement combination or the essential fatty acid). 168 A third shortcoming is the lack of control over the participants' diets. It is unknown what foods and beverages each participant ingested during the study. For example, Conners (1989) notes that foods can have an important effect on children's behavior. However, had diets been controlled during the study, whether the origins of treatment effects were attributable to diet or medications could not be determined. A fourth shortcoming is the possibility of a carryover effect to Trial II for those participants taking the dietary supplement combination during Trial I. However, the length of carryover effects in unknown. These children, part of the control groups during Trial II, had an added benefit of being on the dietary supplement combination for an additional 12 weeks. Thus, this benefit may decrease the opportunity for children in the treatment groups during Trial II to demonstrate a treatment effect from the essential fatty acid. A fifth shortcoming is the small sample size in some groups. While each group began with 15 participants, attrition and noncompliance of teachers completing and

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169 returning the rating scales decreased the number in each group to as few as 9 The probability of finding a treatment effect increases with larger and more homogeneous samples. A sixth shortcoming is unknown compliance by the participants with respect to ingesting the treatment medication. Those already taking Ritalin are accustomed to the regimen of taking medication several times daily. However, those not used to such a regimen may not be as diligent in taking the study medication. If the study medication was not taken regularly, it may be more difficult to detect differences between the treatment and control groups. A seventh shortcoming involves unknown reliability of the dietary supplement ingredients and essential fatty acid. The consistency of the potency for each product used during the study cannot be confirmed. Furthermore, whether comparable ingredients from the same or another company would have the same potency is unknown. An eighth shortcoming involves the use of subjective rating scales The Conners' Rating Scales-Revised: Long Version includes parent and teacher indicators of observable behavior. However in the absence of information gathered from more direct observations, whether rating scales provide

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170 a full and accurate representation of each child's behavior is difficult to determine. Recommendations for Future Research Mixed results from Trial II suggest further study of essential fatty acids as a potentially effective alternative or complementary treatment is necessary. Essential fatty acids should be tested independently of any other treatment to test for possible treatment effects. The double dietary supplement combination also should be tested independently of other treatments This combination functioned as a uniform intervention to detect any significant differences in the groups receiving the essential fatty acid. Although the single dietary supplement was shown to be ineffective at ameliorating children's inattentiveness and hyperactivity-impulsivity, the double dose may potentially offer some benefit. Regardless of the treatment used, a larger sample size should be used. A larger sample would increase the likelihood of detecting any treatment effects. A stratified sample would increase the likelihood of obtaining both males and females of different ages. Research also should be conducted with adolescents and compared to results from children receiving the same

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171 intervention Children's faster body metabolism may make it more difficult to detect treatment effects at a particular dosage. Results from this study indicate the use of a double dietary supplement combination with an essential fatty acid may not be a reliable treatment for ADHD. Anecdotal evidence suggests the combination's ingredients are helpful in reducing inattentiveness, hyperactivity, and impulsivity However, more empirical research is needed before it can replied upon as a viable alternative to Ritalin for the treatment for children with ADHD.

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APPENDIX A ADHD RESEARCH PROTOCOL

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TITLE: Alternative Treatment For Attention Deficit Hyperactivity Disorder (ADHD) in Children A study designed to identify an effective alternative to prescription medication for the treatment of ADHD. INVESTIGATORS: Ronald W. Lynch, M.D. DATE: Amid Habib, M.D. Robert A. Evans, Ph.D. Donna Johnston, N.D., C.H. Bonnie J. Snyder, M.S., Ed.S. June 21, 1997 ABSTRACT: Attention Deficit Hyperactivity Disorder (ADHD) in children is traditionally treated with a prescription stimulant medication (e.g., Ritalin, Cylert, and Dexedrine). While this treatment modality has been shown to be effective in about 75 % of the cases, many parents of ADHD children typically object to their children being placed on a medication at relatively young ages. Recently, many alternative approaches to the treatment of ADHD have been marketed to the general population without scientific validity as to their effectiveness. Various combinations of herbs, vitamins, minerals, trace metals, and diets have been offered as solutions to ADHD with questionable results. The purpose of this study is to evaluate the effects of a dietary supplement combination (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, and Glutamine) and an essential fatty acid (i.e., flaxseed) on children identified as having ADHD, Combined Type. Concerns have been raised regarding a number of adverse reactions from taking Ritalin. If an effective alternative could be identified, then such issues as growth retardation, sleep interference, or appetite suppression could be eliminated. This is a single-blind study Parents, teachers and data collectors will not know what substances the children are taking until the end of the project. Only the physician in charge of the study will know what substances each child is taking. The children will first be identified as either taking Ritalin or not taking Ritalin Those taking Ritalin will then be divided into two groups, with half receiving the treatment and the other half receiving a placebo. The non173

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174 medication group will be given the same treatment and placebo. The groups that initially received the dietary supplement combination during Trial I will receive a double dietary supplement combination during Trial II. The groups that initially received a placebo during Trial I will receive a double dietary supplement combination with an essential fatty acid. During Trial I, it is hypothesized that the dietary supplement combination group lA will display less inattentiveness and hyperactivity-impulsivity than the placebo group lB as measured by the Conners' Rating Scales. It is hypothesized that the Ritalin plus dietary supplement combination group 2A will display less inattentiveness and hyperactivity-impulsivity than the Ritalin plus placebo groups 2B as measured by the Conners' Rating Scales-Revised. During Trial II, it is hypothesized that the double dietary supplement combination with an essential fatty acid group lB will display less inattentiveness and hyperactivity-impulsivity than the double dietary supplement combination group lA as measured by the Conners' Rating Scales. It is hypothesized that the Ritalin plus double dietary supplement combination with an essential fatty acid group 2B will display less inattentiveness and hyperactivity-impulsivity than the Ritalin plus double dietary supplement combination group 2A as measured by the Conners' Rating Scales-Revised. CRITERIA FOR PATIENT INCLUSION: Patients will be children between the ages of 4 and 12 identified as meeting the DSM IV criteria for ADHD, Combined Type. Those with other medical or psychiatric disorders will not be chosen for participation in the study. Those taking a stimulant medication other than Ritalin also would not be asked to participate in the study Those already taking Ritalin will continue to receive their medication as prescribed by their physicians Sixty children will be chosen for the study. Parents of study participants will be asked to complete a Conners' Parent Rating Scales-Revised: Long Version. Teachers of these children will be asked to complete a Conners' Teacher Rating Scales-Revised : Long Version. SAFETY PARAMETERS: Children will receive a thorough physical examination by their personal physician, including a blood analysis.

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175 TIME AND EVENT SCHEDULE: The study will commence November 7, 1997, after the beginning of the 1997-1998 school year in Florida, which begins in August 1997. This time was targeted to allow teachers to become familiar with their new students and be able to complete their behavior rating forms with confidence. The termination date presently is scheduled for May 1998. Event 1: Initial Screening and Invitation to Participate At the commencement of the study, candidate participants will receive invitations to complete a brief screening questionnaire The purpose of this initial screening phase will be solicit candidate subjects from which the actual study participants will be drawn. Once candidates are identified, then the initial screening will identity children who meet the matching criteria. These families will be invited to Event 2, a formal invitation to participate and execute the appropriate releases. Event 2: Orientation Meeting A meeting will be held to explain the purpose of the study and the implementation procedures. The parents of the participants chosen for the study will be asked to sign a participation permission form along with all appropriate releases. They will then be asked to complete the checklists and rating scales and be given school forms to be completed by their teachers. Included in the materials will be a Study Participant Information Form. Event 3: Data Collection A total of sixty (60) participants are expected to be included in the study. Participants' records will be screened by the study physician and have their blood samples taken for subsequent analysis at a local laboratory. In cases where there is a primary care physician already treating the participant, they will be asked to provide the laboratory tests needed and a copy of their last physical. If these were not completed or available, they will be completed by the physician of their choice. It is acceptable if these procedures have been completed within the last 12 months. All children will have baseline data collected via the rating scales and questionnaires completed by their parents and teacher, and collected by the study team. Data will be collected at the beginning of the study, at the end of Trial

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176 I (lasting 12 weeks), and at the end of Trial II (lasting 12 weeks). Participants will be assigned to one of 4 groups prior to Trial I (Figure 1). For those individuals who have never been on medication, these groups are: (lA) dietary supplement combination or (1B) placebo. For those individuals who are on Ritalin, they will be assigned to either (2A) Ritalin plus dietary supplement combination or (2B) Ritalin plus placebo. Only the study physician and Dr. Johnston will know what each participant is taking. Event 4: Nutritional Supplement Combination Dispensing Upon commencement of the study, participants will receive and begin taking their dietary supplement combination. They will be instructed to take the nutritional combination twice a day, once with breakfast and again with an afternoon snack or with dinner. Regardless of the schedule they are taking Ritalin, they will be asked to take the supplements every day. Event 5: Data Analysis The University of Florida in Gainesville has agreed to provide data analysis and student volunteers. Event 6: Reporting of Results The study team will review the findings and report the results in a publishable document. This report will be sent to various professional publications for consideration. PREPARING, PACKAGING, AND DISPENSING TREATMENTS: The dietary supplement combination and placebo treatment will be in capsule form. Ritalin will be in the capsule form. Dr. Johnston will dispense nutritional combination to the physician if there are any adverse reactions, although none are anticipated. INFORMED CONSENT: The parents of participants will sign a consent form permitting their children to participate in the study and they will receive a study protocol explaining the study and procedures thoroughly. In addition, a Release of Information form will be signed in order to obtain relevant information from primary care physicians when appropriate.

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177 Trial & Treatment Group Treatment Ingredients & Dosages Trial I, Dietary Ginkgo biloba 10 mg; Melissa Group lA supplement officinalis 200 mg; Grapine (Treatment) combination 30 mg; dimethylaminoethanol 35 mg; L-Glutamine 100 mg Trial I, Placebo Slippery elm supplement 220 Group lB mg (Control) Trial I, Ritalin plus Ginkgo biloba 10 mg; Melissa Group 2A dietary officinalis 200 mg; Grapine (Treatment) supplement 30 mg; dimethylaminoethanol combination 35 mg; L-Glutamine 100 mg Trial I, Ritalin plus Slippery elm supplement 220 Group 2B placebo mg (Control) Trial II, Double dietary Ginkgo biloba 20 mg; Melissa Group lA supplement officinalis 400 mg; Grapine (Control) combination 60 mg; dimethylaminoethanol 70 mg; L-Glutamine 200 mg Trial II, Double dietary Ginkgo biloba 20 mg; Melissa Group lB supplement officinalis 400 mg; Grapine (Treatment) combination 60 mg; dimethylaminoethanol with an 70 mg; L-Glutamine 200 mg; essential fatty flax seed 1,000 mg acid Trial II, Ritalin plus Ginkgo biloba 20 mg; Melissa Group 2A double dietary officinalis 400 mg; Grapine (Control) supplement 60 mg; dimethylaminoethanol combination 70 mg; L-Glutamine 200 mg Trial II, Ritalin plus Ginkgo biloba 20 mg; Melissa Group 2B double dietary officinalis 400 mg; Grapine (Treatment) supplement 60 mg; dimethylaminoethanol combination 70 mg; L-Glutamine 200 mg; with an flax seed 1,000 mg essential fatty acid Figure 1. Treatment during Trials I and II

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178 RATIONALE FOR SELECTING NUTRITIONAL COMBINATION: According to Russell Barkley, ADHD consists of developmental deficiencies in the regulation and maintenance of behavior by rules and consequences. These deficiencies give rise to problems with inhibiting, initiating, or sustaining responses to tasks or stimuli and adhering to rules or instructions, particularly in situations where consequences for such behavior are delayed, weak or nonexistent. The deficiencies are evident in early childhood and are probably chronic in nature. Although they may improve with neurological maturation, the deficits persist in comparison to same-age normal children, whose performance in these areas also improved with development. In attempting to identity the etiology of ADHD, Hallowell and Ratey recount the scientific treatment history of ADHD. They stated that ADHD lives in the biology of the brain and the central nervous system. Although environmental factors do influence the course of the disorder over a lifetime, most practitioners now agree that the characteristic problems of people with ADHD stem from neurological malfunctioning. While the exact mechanism underlying ADHD remains unknown scientific inquiry has yielded some clues as to the locations and biochemical states that may account for the manifestation of the disorder. In 1970, Kornetsky proposed the Catecholamine Hypothesis of Hyperactivity. Catecholamines are a class of compounds that includes the neurotransmitter norepinephrine and dopamine. Because stimulants affect the norepinephrine and dopamine neurotransmitter systems by increasing the amount of these neurotransmitters, Kornetsky concluded that ADHD possibly was caused by an underproduction or under utilization of these neurotransmitters. Hallowell and Ratey go on to state that no single neurotransmitter system may be the sole regulator of ADHD. Neurons can convert dopamine into norepinephrine. Many of the drugs that act on the catecholamine act on serotonin. Some of the drugs that act on serotonin can act on norepinephrine and dopamine. The role of other neurotransmitters like GABA (gamma amino butyric acid), which has shown up in some biochemical studies can not be ruled out, according to Hallowell and Ratey. They hypothesize that the effect of dopamine, norepinephrine and serotonin is key and drugs that alter these neurotransmitters will have the most telling effect on the symptomatology of ADHD.

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179 Because of the neurological complexities associated with ADHD, other biological conditions need to be considered as well as neurotransmitter involvement. Zametkin conducted a study in 1990 where he examined the activity of the brain in adults with and those without ADHD. He focused on how the brain uses glucose, its energy source, during a continuous performance task. Using PET scans to record the radioactivity given off by the brain after it has used radio-labeled glucose during the tasks, Zametkin found a deficiency in glucose uptake; a deficit in energy use in the brain. Overall, the ADHD group metabolized glucose at rates 8 percent lower than the control group. This reduction in glucose uptake was widespread throughout different regions of the brain. The decrease in metabolic activity was largest in the prefrontal and premotor regions of the brain; the major regulators of behavior. This region of the brain keeps impulses in check, allows for planning and anticipation and serves at the place where we initiate behavior. It gets input from the lower brain, which regulates arousal, screens out irrelevant stimuli, and serves as the seat of fight-or flight reactions. It receives input from the limbic system, the seat of emotion, hunger, thirst, sexuality, and other physiological impulses. It also is the site of working memory, the combination of moment-to-moment experience and long term memory. Thus the frontal lobes synthesize sensory and cognitive information, they orchestrate attention and they function as the gateway to action. The frontal lobe involvement appears consistent with other research because of the similarity between ADHD symptoms and frontal-lobe syndromes resulting from injuries or lesions to this area of tile brain. According to prevailing theory, many of the symptoms of ADHD arise because the brain loses its ability to "put on the brakes" sufficiently. This is because of the disturbed inhibition in tile cortex of the brain. Without cortical inhibition, the brain fails to block inappropriate responses and fails to send out appropriate inhibitory messages. The result is as inhibition breaks down, impulsivity and hyperactivity rise concurrently. Giving support to this hypothesized frontal lobe involvement, Lou found decreased blood flow in the frontal regions of the brain in people with ADHD. Lou's study indicated a deficit in blood flow in the right hemisphere of the brain as compared to the left; supporting the current thinking that ADHD is related to right-hemisphere

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180 dysfunction. This hemisphere controls the so-called executive or decision-making capacities, visual-spatial ability and the ability to process many sources of stimuli simultaneously. Our choice of the dietary supplement combination was based on this description of the neurobiology suspected in ADHD. In addition common elements, per anecdotal records, that have been identified as successful have been chosen for inclusion in this study. The combination selected, therefore, will increase the rate of blood flow in the brain and enhance brain function and support the nervous system. A brief discussion of each natural substance is presented below. MELISSA OFFICINALIS (LEMON BALM): Contains nervine principles which both relax and restore to balance the functions of the brain and nerve cells. Often used in treatment of children's hyperactivity, excitability, anxiety patterns and nervous sensitivity. GINKGO BILOBA CONCENTRATE: Ginkgo biloba is a powerful antioxidant herb that enhances peripheral and cerebral circulation It is reported that it has the ability to squeeze through even the narrowest of blood vessels to increase the supply of oxygen to the heart, brain and all other body parts. Ginkgo is used primarily as a brain and mental energy stimulant and increases the quality of blood flow to the brain to improve memory, mental clarity and alertness. GRAPINE: Grapine is a high potency anti-oxidant known to cross the blood brain barrier to project oxygen to the brain and central nervous system. It has exhibited the ability to improve mental alertness and relieve learning disabilities. In addition, it moderates allergic and inflammatory responses by reducing histamine production. DIMETHYLAMINOETHANOL: A choline precursor that more easily crosses the blood-brain barrier. Increases the brain's potential to make neurotransmitters. Reported to have the following effects: mood elevation, improvement of memory and learning and increased intelligence. L-GLUTAMINE: Glutamine readily passes the blood-brain barrier, therefore, it is often referred to as brain fuel. Glutamine increases the amount of GABA needed to sustain

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181 proper brain function and mental activity. It assists in maintaining the proper acid/alkaline balance in the body and is the basis of the building blocks for the synthesis of RNA and DNA ESSENTIAL FATTY ACID: Known as Vitamin F, these fatty acids (e.g. flaxseed) are essential for health but cannot be made by the body High concentrations of EFAs are found in the brain. EFAs aid in the transmission of nerve impulses and are needed for the proper functioning of the brain A deficiency of EFAs can lead to an impaired ability to learn and recall information. Dosage--Nutritional Combination: Twice a day for children up to age 12. BUDGET Personnel Test Administrator (300 hours@ $10 00/hr.) Data Entry (300 hours@ $10.00/hr.) Coordinator (200 hours@ $10.00/hr ) Clerical (200 hours@ $10 00/hr.) Materials Postage Reproduction Paper Conners' Rating Scales-Revised Services Rating Scale Scoring Data Analysis Total $3 000.00 3 000.00 2 000.00 2 000.00 200.00 250 00 150 00 4,500 00 2,000.00 5,000 00 $22,600 00

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APPENDIX B ORLANDO REGIONAL HEALTHCARE SYSTEM INSTITUTIONAL REVIEW BOARD FACT SHEET

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Orlando Regional Healthcare System Institutional Review Board Fact Sheet I. IDENTIFICATION ORHS Project# 91.048.11 Project Title: Alternative Treatment for Attention Deficit Hyperactivity Disorder (ADHD) In Children. Phase: Initial Principal Investigator(s): Ronald W. Lynch, M.D., Robert A. Evans, Ph.D., Donna Johnston, N.D., C.H., & Bonnie J. Snyder, M.S ., Ed.S. Study Coordinators: Bonnie J. Snyder, M.S., Ed.S. Mailing Address: 2811 West State Road 434 Longwood, Florida 32779 Phone Number: (407) 774-3141 Fax Number: (407) 774-4293 Email: BONSNYDER@AOL.COM Sponsoring Company: Alternatives: A Center for Caring, Inc. is conducting the study; dietary supplement combination and placebo are being provided by Nature's Sunshine Products, Inc., Provo, Utah. Protocol#: N/A Study#: N/A Drug Supplier (if any): Not Applicable Sponsor's Contact Person: Bonnie J. Snyder, M.S., Ed.S. Phone Number : (407) 774-3141 Duration of Project: 24 weeks Start and stop dates: 11/7/97-5/29/98 Investigation Drug/Device Ind# or Ide# (not model#): Not Applicable 183

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II. STUDY INFORMATION A. Where is study to be conducted? List nursing units: Alternatives : A Center for Caring, Inc.; No nursing units involved. B. Type of Study: Alternative Treatment Drug Device X Other 184 C. Brief Description of Study: Evaluate the effects of a dietary supplement combination (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, L-Glutamine, and an essential fatty acid) on children identified as having ADHD. D. Describe Benefits Expected: The dietary supplement combination will provide the same benefit as the prescribed medication Ritalin, yet the children will be able to avoid typical adverse reactions associated with medications E. Risks: None F. List Procedures or Medications Involved in the Study: Children will be assessed with rating scales and a continuous performance test at the beginning, middle, and end of the study. Children also will be randomly assigned to either a nutritional combination group or a placebo group. After 12 weeks, the children will switch to either a double dietary supplement combination or double dietary supplement combination and essential fatty acid group. Children will be re-evaluated using the rating scales. III. POPULATION (Check all which apply) [ ] Adults 18 and over # [ ] Fetuses [X] Minors (Age 4-12) # 60 [ ] Abortuses [ ] Mentally Retarded # [ ] Prisoners [ ] Mentally Disabled # [ 1 Pregnant Women

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185 IV. ORHS PERSONNEL A. Will ORHS personnel (other than research coordinator) be involved in activities to conduct this study? YES NO X If Yes, how many? __ Which departments? B. Will these activities involve additional functions that are above and beyond what the individual usually does in the course of the job? YES NO X C. List specific functions and the type of personnel that will be involved in the research activity. Not Applicable D. What is the estimated number of ORHS personnel per day that will be involved in the research study? Not Applicable E. What is the estimated times per day required by ORHS personnel to perform research activities? Not Applicable F. Will additional education be required of ORHS personnel in order to participate in data collection or research activities? Not Applicable G. If ORHS personnel are used in a study, the administrator of each department must sign off on the study prior to presentation to the IRB. This project has been reviewed by my department, including its impact on my area. We are in support of this application. Department Head Signature: ------------------

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186 V. RESEARCH BUDGET A. Will ORHS be required to add additional equipment? Yes No X -If yes, please specify type and estimated cost: B. Will there be any costs that need to be underwritten by ORHS? Yes No X If Yes, what dollar amount?$ C. Will the patient be responsible for certain charges? Yes_X_ No If Yes, what dollar amount? $ lab charges may vary VI. ADVERTISEMENT Will you be advertising directly for subjects for your research? No If yes, please attach a copy of the exact wording to be used. VII. ASSURANCE No research may involve human subjects until approval is granted by the Institutional Review Board. I affirm that the above information is correct and complete to the best of my knowledge. I agree to abide by the conditions, requirements and decisions of the IRB and to keep the IRB informed of the progress and results of this research as requested. I will inform the IRB by letter of all unexpected adverse events and will not change the protocol prior to IRB approval, except to remove any immediate hazards. I will notify Patient Accounting at x8968 of each patient enrolled in house. I understand that 10% of the total budget will be assessed for overhead on funded studies that use in-house patients. Signature of Principal Date

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APPENDIX C ORLANDO REGIONAL HEALTHCARE SYSTEM INSTITUTIONAL REVIEW BOARD APPROVAL

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A HEAL TH SCIENCES CENTER f. 1 ,; JT 11/ O r londn R(g io n al H wlc hc.ir ( S :,s ccm 1-114 Kuhl A v enut Orll n d o. F lo rid~ 32&'6 ( 4 0il U6,9i94 November 7 1997 Robert A Evans Ph.D 2811 West State Road 434 Longwood, FL 32779 RE: ORHS Pro j ect# 97 048 11 Dear Or. Evans: The Institutional Review Board (IRS) of Orlando Regional Healthcare System has reviewed and approved the protocol and the consent for your project entitled "Alternative Treatment for Attention Deficit Hyperactivity Disorder (AF/HD) In Children The comm i ttee has approved this study at all ORHS facilities Nemours Orlando facilit i es and your office The Institutional Review Board review process Included review of potential risks to subjects, risk benefit ratio, subject select i on criteria and safety, content of the informed consent, confidentiality and appropriate safeguards. The project was reviewed in detail at the November 6, 1997 Institutional Review Board meeting and was approved by a majority of membership with quorum present. Subjects may be enrolled in your project from November 7, 1997 through November 5 1998 For approval to be extended after that date, a continuing review report must be submitted to the Institutional Review Board meeting prior to the deadline date. A form for cont i nuing review will be sent to you prior to the deadline If you wish to term i nate your project before the expiration date, p l ease notify the Clin i cal Research Office at 841-5111, ext. 5837 Institut i ona l Rev i ew Board approval is contingent upon: 1 Subjects may not be enrolled prior to Inst i tut i onal Rev i ew Board approval nor after the expiration date 2 A ll serious adverse events must be reported to the Inst i tutional Rev i ew Board within 5 working days Use the attached form 188

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189 Evans 97.048.11 Page Two 3 Modifications to protocol or informed consent must be approved prior to implementation unless they reduce immed i ate danger to subject. 4 All significant protocol deviations must be reported to Institut i onal Review Board within 5 working days. 5 All advertisements must be approved prior to use and conform with Orlando Regional Healthcare System policy. All subjects who are patients in an Orlando Regional Healthcare System facility at the time of enrollment must be reported to the Clinical Research Office within one working day. Please call Chloe Rhamstine at 841-5111, ext. 5837 with the name and medica l record number. If you have any questions, please feel free to contact Chloe Rhamstine. Sincerely, Richard Banks, M D. Chairman of Institutional Review Board

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APPENDIX D UNIVERSITY OF FLORIDA INSTITUTIONAL REVIEW BOARD APPROVAL

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Institutional Review Board TO: FROM: SUBJECT: February 5, 1998 Dr. Thomas Oakland and Mr. Alan Brue Foundations of Education 1403 NRN Campus 11' Harriet S. Hayes, Executive Secretary '""~. University of Florida Institutional Review Bo~~ UFIRB Project #98.060 98A Psychology Bldg. PO Box 112250 Gainesville, FL 32611-2250 (352) 392-0433 Fax (352) 392-0433 Alternative Treatment for Attention Deficit Hyperactivity (AO/HD) in Children The project referenced above has been reviewed by the Chair of the Institutional Review Board (IRS 02). He has determined that this project involves analysis of previously collected data, presented without identifiers ; therefore, it is exempt from further review by this Board in accordance with 45 CFR 46. If a revision of this project should indicate the need for human research participant's involvement, please contact this office for additional review. CMUher cc : Vice President for Research (Alternatives : A Center for Caring, Inc ) 191 Equal Opportunity / Affirmative Action INtitution

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APPENDIX E STUDY PARTICIPANT INFORMATION FORM

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STUDY PARTICIPANT INFOR.i\1ATION STUDY PARTICIPA.t"IT'S NAME: Last First M.I. Birthdate: Age: __ Sex : __ Race: __ Ref. Physician: _____ What medical problems is your child currently having? ________________ Are those problems being treated? Yes No If yes, by whom? __________ Informant name __________________ Relationship to child ___ Referred By ______________________________ Drug Allergies-------------------------------Food Allergies------------------------------Parents Mother's name ______________________ Stepmother? No Yes Address-----------------------------------Home phone _______________ Work phone ___________ Occupation Employer ____________ How long with present employer? Highest grade completed _______ Father's name _____________________ Stepfather? No Yes Address---------------------------------Home phone _______________ Work phone _____________ Occupation Employer ____________ How long with present employer? Highest grade completed _______ Does this child have other parent(s) / stepparent(s)? If yes, please provide the following information. No Yes Name __________________________________ Relationship to this child __________ Home phone ___________ Address ___ ______________________________ Name __________________________________ Relationship to this child __________ Home phone ___________ Address---------------------------------Consent To Photograph: YES NO_ (Photographs will be part of your child's records, may be used only for medical, scientific or educational purposes. The name of the participant and their family will not be used to identify these photographs.) 193

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194 Birth At this cfuJd's binh, what was the mothds age'? ____ Father's age'? ___ Mother's age at birth of first child? ___ Was this child born in a hospital? Yes No If no, where? ____________ Length of pregnancy: ____ weeks Birth weight: ___ lbs ___ oz Length of labor: hours Apgar score: Child's condition at birth ____________________________ Mother s condition at birth ___________________________ Check any of the following complications that occurred during birth. D Forceps used D Breech birth D Labor induced D Caesarean delivery D Subdural anesthesia D Other delivery complications: Describe ______________________ D Incubator: How long? ____________________________ Jaundiced: Bilirubin lights? No Yes If yes, how long? ____________ D Breathing problems right after birth: Describe __________________ Supplemental oxygen? No Yes If yes, how long? ____________ Was anesthesia used during delivery? No Yes If yes, what kind? __________ Length of stay in hospital: Mother: ___ days Child: ___ days Development At what age did this child hrst do the tollowmg? Please mdicate year/month of age. Walk down stairs Show interest in or attraction to sound Understand first words _______ Turn over _______ Sit alone _______ Crawl _______ Stand alone _______ Walle alone _______ Walle up stairs _______ Speak first words Speak in sentences Was this child breast-fed? No Yes When weaned? ________ Was this child bottle-fed? No Yes Whenweaned? ________ Name of formula ______ When was solid food introduced? ______ F ceding difficulties (please circle) Vomiting Spitting up Colic Skin Rashes Diarrhea Constipation Others? Explain: When was this child toilet trained: Days: ____ Did bed-wetting occur after toilet training? No Yes Did bed-soiling occur after toilet training? No Yes Were there any medical reasons for bed-wetting or soiling? Nights: ___ If yes, until what age? ___ If yes, until what age? ___ No Yes If yes, please describe. Has this child experienced any of the following problems? If yes, please describe. Walking difficulty No Yes Unclear speech No Yes Feeding problem No Yes l.'nderweight problem No Yes

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195 Child's Medical History Overweigbt problem No Yes Colic No Yes Sleep problem No Yes Eating Disorder No Yes Difficulty learning to ride a bike No Yes Difficulty learning to skip No Yes Difficulty learning to throw / catch No Yes During this child's first 4 years, were any special problems noted in the following areas? If yes, please describe, indicate age occurrence began and if it is still continuing Eating No Yes Motor skills No Yes Sleeping too much No Yes Temper tantrums No Yes Sleeping too little No Yes Failure to thrive No Yes Separating from parents No Yes Excessive crying No Yes \Vhich hand does this child use for writing or drawing? ______________ Eating? __________ Other (throwing, etc.)? _________ Childhood Uloesses/Injwies Plea.se ch.eek th.e illnesses this child ha.s had and indicate ace (;jear / mcmth) D Measles _________ Rheumatic fever __________ D German Measles ______ D Diphtheria D Mumps __________ o Meningitis Chicken pox o Encephalitis D Tuberculosis o Anemia D Whooping cough _____ Fever above 104 _________ Scarlet fever ___________________________ Head injury: Describe _______________________ Coma or loss of consciousness: Describe ---------------Sustained high fever: Describe ___________________ P l ease describe 0th.er serious illnesses or opera.Jions: Illness / Opera ti on Age Has this child ever been on long-term medication (more than 6 months)? No Yes If yes, when? ___________ What kind? __________

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196 Primary Caregivers With what adult(s) does this chbd Live} -----------------------'--How long in current living situation? ________________________ Please prouide the following information about primary caregiuers, if not gi u en preuiou.sly. Name ___________________ Relat i onsh i p to child _______ Address---------------------------------Home phone ________________ Work phone ____________ Occupat ion Employer _____________ How long w ith present employer? Highest grade completed _______ Name Re l ationsh i p to child _______ Address---------------------------------Home phone ________________ Work phone ____________ Occupation Employer _____________ How long with present employer? Highest grade completed ______ Child Care if primary cangiuers work outside du hoTTIJ!, please prouide the following infonnarion. Who cares for this child when caregivers are gone? _________________ How many hours per day is this child in a child-care setting? _____________ How many different peop le care for this child? (Please explain.) ____________ Family History Is this child closer to one parent than tne other? No Yes If yes, which? ______ Has th i s child ever exper ien ced any parental separations, divorces, or death? No Yes If yes, when? ____________ How old was this child at the time? ___ Please describe the circumstances. ______________________ If parents are separated or divorced, who has custody of this child? ___________ How often does the other parent see this child? (chuk one) Weekly or more often Once or twice a month Few times a year o Never Brothers/Sisters Please list a/.l brothers and sisters, and any other cluldren liuing with th.e family. Age Sex Relationship to this child Living at home? 'iOw aces this cn110 get a10ng wnn orotner\SJ ana,or s1ster(syt Participant's Residence (c hl!ck one) Apartment o Single home o Other _____ Total Income o S15,000 How long at current address? __ $40 60,000 S16 25 000 __ Above 60 000

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197 Family Medical and Psychiatric History Have family members had any of the foilowing? If yes, please specify family membePs relationship 10 this participant. If participant is not living with biological parents, please include health information on biological parents if known. Maternal Relatives Attention Deficit Hyperactivity Disorder ____________ Alcoholism Drug Abuse Depression Suicide Obsessive/Compulsive Disorder o Anxiety Disorder Panic Attacks Psychiatric hospitalizations Other mental illnesses {Specify) Cancer Cystic fibrosis Diabetes Heart disease o High blood pressure Kidney disease Migraine headaches Multiple sclerosis Stroke Tuberculosis Alzheimer's disease Hemophilia Huntington's chorea Muscular dystrophy Parkinson's disease Sickle-cell anemia Tourette's syndrome Cerebral palsy Emotional disturbance Mental retardation Nervousness Seizures or epilepsy Reading problem Leaming disability Speech or language problem Other: Describe ------------Paternal Relatives

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198 Please indicate whether the partic i pant currently has any of the following problems If yes, descr i be how often. Respiratory Frequent colds No Yes Chronic cough No Yes Asthma No Yes Hay fever No Yes Sinus cond i tion No Yes D iffi culty breathing No Yes Cardiovascular Shortness of breath or d i zz i ness with physical exert i on Activity limitation due to heart condition Heart murmur Gastrointestinal Excessive vom itin g Frequent diarrhea Constipation Stomach pain Burping/Gas Daily Bowel Movements Cramping Ind i gestion after eating GenitourinarJ'. Urination in pants/bed Frequent urination Strong odor to ur in e Bedwetting (ages if yes ) Musculoskeletal Muscle pain Clumsy walk Poor posture Other muscle problems Skin Frequent rashes Bru i ses easily Sores Severe acne Itchy skin (eczema) No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes If not how often? When? ____ Where? _____ lf yes, describe ___________ If yes, describe ___________

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199 Nervous S:istem Level of stress: Mild Moderate High Family School Friends Other Sleep Problems Difficulty falling as l eep Difficulty waking Wakes during night Nightmaresnerrors Sleep Walking Neurological Seizures/ convulsions No Yes If yes, describe Speech defects No Yes Accident prone No Yes Bites nails No Yes Sucks thumb No Yes Grinds teeth No Yes Has tics/twitches No Yes Bangs head No Yes Rocks back and forth No Yes Bowel movements in pants/bed No Yes Allergies Allergy to medicine No Yes If yes, describe Allergy to food No Yes If yes, describe Other allergies No Yes If yes, describe Hearing Ear infections No Yes Hearing problems No Yes Ear tubes No Yes Date of most recent hearing exam No Yes Vision Vision problems No Yes Wears glasses/contacts No Yes Date of most recent vision exam No Yes

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200 Medical Care chdd's phys1c1an ----------------Telephone _________ Address-----------------------------------How often does this child see a doctor? ______ Date of last visit _______ Is this child currently on medicat i on? No Yes If yes, indicate type and reason (age and duration) _______________ Nutritional History (Please circle) Appetite Appetite increase/decrease Food cravings: Excess i ve/Good/Poor/Picky Yes/No Weight loss/gain Skips meals Yes/No Yes1'-Jo Yes1'-Jo Craves Sweets Craves salt Yes/No Yes/No Yes/No Craves dairy Other cravings List: __________ Drinks water No. of glasses per day __ Tap water Purified water Bottled water Other We need a clear understanding of your child's typical daily diet. Also i~rtant would be something eaten on a consistent basis O.e 3 to 4 times per week). Please note any reactions or behavior changes you have observed after your child has eaten these foods. Please indicate the number of servings per day: Fruits Fruit juices Cereals Name cereals : _______ White flour products __ (pasta breads, muffins bagels) Da i ry Products (milk, cheese, yogurt, ice cceam) Other drinks O.e. Kool-aid, Gatorade etc.-) -NutriSweet Nutritional Supplements Y6Sl'No Vegetables Potatoes Chicken/Turkey Red Meat Sweets/Sugars __ (desserts, cookies, candy, cakes) Soda Pop ___ Favorite brand? ______ Diet/Caffeine Free/Regular Name ____________________ Salty Snacks Fast Food (vitamins, herbs) Please list ______________________ Typical Daily Food Intake Please give us information on three typical days diet, include snacks and beverages. Breakfast Lunch Dinner Snacks

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201 Behavior Temperament Please circle YES, NO, or ST for Sometimes as to whether this chdd exh1b1ts any of the fo!low,ng: Is eas il y overstimu l ated in play YES NO ST Requires a lot of parental attention YES NO ST High activ i ty level, a lways busy YES NO ST Seems unhappy.,. ... .... .... .............. YES NO ST Has a short attent ion span YES NO ST Withholds affection ........................ YES NO ST Seems impulsive...................... YES NO ST Does not express feelings ............ YES NO ST Overreacts, very emotional Seems uncomfortable meeting new when faced with a problem YES NO ST people YES NO ST Has trouble getting along with Seems anxious or apprehens iv e YES NO ST s iblings YES NO ST Moody, frequent mood change YES NO ST Educational History Does or did this child attend preschool? ......... NO YES Has changed schools for reasons other than normal academ ic progression........... NO YES Has been retained a grade in school ........... NO YES Has difficulty with reading ............................ NO YES Has diff i culty with ma th .. .. .... ........... ........ . . NO YES Has difficulty with writ ing ............................ NO YES Gets poor grades . ...... . . ............ .. ... .. .. . .. NO YES Has been tested for Spec i al Education ..... NO YES Currently is placed in Special Education class NO YES Has anyone in the family been in Special Educat i on ... ................... .... ..... NO YES Child currently enrolled in (circle one) PUBLIC School Name: _____________ Grade Currently Enrolled In _________ At wnat age? _________ If yes, when and why? _____ If yes, when and why? _____ If yes describe ________ If yes describe ________ If yes describe ________ Describe most recent report card __ If Yes, when _________ If Yes, what class? __ Hrs. per day __ If Yes, who: _________ PRIVATE HOME SCHOOL County ___________ Teacher(s) Names: _______ Child's attitude toward school -------------------------Tutoring YES NO If yes, how many times per week ______________

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202 Social History Please in dicate how this chi!d relates to other cni!dren. Has problems relating to or play in g w ith other children NO YES If Yes, describe ____________________________ F i ghts frequently w i th playmates .. ... .... NO YES _________________ Prefers p l ay i ng w ith younger ch il dren NO YES _________________ Has d i fficulty making fr i ends ................ NO YES ________________ Prefers to play alone ........................... NO YES _________________ Does your child have a best fr i end? ... NO YES If Yes, what is their name: _______ Recreation/Interests What activities does this child en i oy? Sports: ________________________ ~Age: _____ Hobbies: __________________________ .Age: ____ Clubs: Age : ____ Religious Activities: Age: _____ Approximately how many hours does your child watch TV on a daily basis? ________ Does your ch il d play computer, v i deo games da i ly? NO YES If Yes, hrs. per day: __ Use five (5) positive adjectives to describe your child: ________________ Mental Health/Counseling Has anyone in your family been in counseling? NO YES If Yes, p l ease describe ___ Name of Counselor: ________ Dates seen: _____________ Frequency: be/week 2x/month_ Occasional Last seen: ________ Legal Issues Has your child ever been in troub l e with the law? NO YES R Yes, please describe ____ How old were they at the time? ______

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203 Abuse{Trauma Has your child ever been physically/sexually abused YES NO Alleged abuse: ______________________________ Duration and frequency extent: _________________________ How d i scovered :. ___________________ ......_ __________ How was situat i on handled after disclosed: __ Changes in ch il d's behavior afterward: ______________________ Has child ever experienced any other severe trauma? YES NO If Yes, expla in: __ S i gnature of person completing form Date I hereby authorize the Study Team, including Amid Habib, M.D.; Robert A Evans, Ph.D.; Bonnie J. Snyder M.S.,Ed.S.; Donna Johnston, N D., C.H.; to obta in information necessary, exam ine and render treatment as necessary for the s tudy. A photocopy shall be valid as the original. I have received, read and understand all po li cies re l ated to this study. S i gnature ____________ Relationship to participant ____ Date __ Pediatric Endocrinology Consultants, P.A. AMID HABIB, M.D., F.A.A.P., F.A.C.E. Douglas Center 789 Douglas Avenue, Suite 137 Altamonte Springs, FL 32714 Phone: (407) 862-0107 Fax; (407) 862-1283 Alternatives: A Center for Caring Healthy Solutions ROBERT A. EVANS, Ph.D. Study Nutritional Consultant BONNIE J. SNYDER, M.S.,Ed.S. DONNA JOHNSTON, N.D., C.H. 2811 W. S.R. 434 2425 W. S R 434 Longwood, FL 32779 Longwood, FL 32779 (407) n,4-.3141 Fax: (407) n4-4293 (407) 865-9902 Fax: (407) 865-9949

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APPENDIX F INFORMED CONSENT FORM

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Alternative Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Children Informed Consent Introduction You and your child are being asked to be in a study designed to identify an effective alternative (i.e., dietary supplement combination) to prescription medication for the treatment of attention deficit hyperactivity disorder (ADHD). This study includes children ages 4 through 12 years old who have been previously diagnosed with ADHD. Your decision to take part in this study is voluntary. Deciding not to be in the study will not cause you to lose any benefits associated with your current healthcare. Please read this consent form carefully and ask as many questions as you like before deciding whether you want to participate. If you decide to participate, and then change your mind, you may withdraw from the study at any time. This experimental research study is being conducted by: Ronald W. Lynch, M.D. Robert A. Evans, Ph.D. Bonnie J. Snyder, M.S., Ed.S. Donna Johnston, N.D., C.H. Purpose of the Study ADHD in children usually is treated with a prescription stimulant medication (e.g., Ritalin, Cylert, Dexedrine). Stimulant medications have been shown to be effective in about 75% of the cases. Many parents of ADHD children, however, object to their children being placed on these medications at relatively young ages or having to keep their children on these medications for a long time. Recently, many alternative approaches to the treatment of ADHD have been marketed to the general population. Various combinations of herbs, vitamins, minerals, trace metals, diets, are among the things people have tried as a substitute for medication. The purpose of this study is to scientifically evaluate the effects of a dietary supplement combination consisting of natural substances (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, L-Glutamine, and 205

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206 an essential fatty acid) on children identified as having ADHD In other words, this study is designed to measure changes in children's behavior as a result of taking a nutritional combination either alone or in combination with Ritalin. Expected Duration You can expect to be part of this research study for six months. The start date was chosen to allow teachers to become familiar with their students in order to complete a Conners' Teacher's Rating Scale-Revised: Long Form (CTRS R:L) on your child with confidence, and to complete the study by the end of the 1997-1998 school year. This rating scale is used to rate children's behavior in a number of areas (e.g. hyperactivity, inattentiveness) Procedures To Be Followed You will be asked to turn in the following information before the study start date: 1. This signed informed consent form indicating your willingness to participate in the study. If your child is 7 or older, they also will sign an assent 2 A completed medical/developmental history form. 3. Medical data for your child, including a blood test results (e.g., CBC, SMAC, Lead Levels). Medical data that is current within the last 12 months are acceptable and do not need to be repeated 4 A completed Conners' Parent Rating Scale-Revised: Long Form, which also must be completed again after each 12-week trial. 5. A completed Conners' Teacher Rating Scale-Revised: Long Form that you give to the teacher with whom your child spend the greatest part of their day. This must be returned via U S. mail prior to commencement of the study. The rating scale must be completed again after each 12-week trial

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207 Your child will be asked to take either a dietary supplement combination or a placebo (i.e., a substance which has no medical value, yet is safe to consume) in capsule form. Only the study physician will know which treatment your child is taking. If your child is already taking Ritalin, the substance will be taken in addition to their medication. The treatments will be provided to you at no cost, and will be mailed to you every four weeks. After the first 12 weeks of the study, your child will be given a different treatment to take. Again, you will not know which treatment your child is receiving. If your child is taking Ritalin, they will again take the treatment in addition to Ritalin. If your child is not taking Ritalin, they will take only the treatment. Again, the treatment will be provided to you at no cost, and will be mailed to you every four weeks. Identification of Experimental Procedures The experimental part of this study is for the use of the dietary supplement combination (i e Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, and Glutamine), and the dietary supplement combination with an essential fatty acid (i.e., Ginkgo biloba, Melissa officinalis, Grapine, dimethylaminoethanol, L-Glutamine, and flaxseed) to treat children diagnosed with ADHD. This collection and comparison of data is to determine if the combination or essential fatty acid results in a change in characteristics related to ADHD (i.e., inattentiveness and hyperactivity-impulsivity). Potential Risks and Discomforts There are no known risks associated with the study substances, and therefore do not expect your child to have any adverse reactions. The dietary supplement combination is considered a "dietary supplement" as defined by the 1994 Dietary Supplements Health and Education Act. However, if a child should take a large quantity, there may be adverse reactions. Adults have not had reported adverse reactions with overdosage, but the effect on children is unknown. A child may experience some dizziness. Observe the child and if concerned, take them to the emergency room.

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208 Potential Benefit to Your Child or Others While there is no direct compensation or benefit to you from being in the study, it is hoped that your child will benefit from this treatment. However, the study substances are not to be considered a cure for ADHD. An indirect benefit of participating is the chance to help your child and other children with ADHD by helping us to better understand alternative treatments for this disorder. Alternative Procedures or Treatments Treatment of ADHD is usually conducted with stimulant medications such as Ritalin, Cylert, or Dexedrine. These medications are prescribed by a child's pediatrician or family doctor. It is common for children and their families participate in individual or family counseling to help families and children address typical symptoms of ADHD. Among these are impulsiveness, low frustration tolerance, non-compliance, oppositional behavior, distractibility and sometimes hyperactivity. Sometimes when children do not respond to the stimulant medications or if there are other problems typically associated with ADHD, such as depression, or obsessive compulsive disorder, other medications are sometimes prescribed, such as antidepressants. Confidentiality of Records The information provided by you about your child and information obtained directly from your child while in this study will be kept confidential. The results of this study may be published for scientific purposes; however, your identity or the identity of your child will not be revealed. Study records may also be reviewed by Orlando Regional Healthcare System Institutional Review Board. Compensation The dietary supplement combination and placebo will be provided at no cost as long as your child continues to participate as directed in the study. Parents are instructed that they are responsible for the cost of any lab work.

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209 Testing (i.e., Conners' Rating Scales-Revised) is free. You will not be paid to take part in this study. Research Related Injury In the event that injury occurs as a result of this research, treatment will be made available. However, neither Dr. Lynch, Alternatives: A Center for Caring, Inc., or Healthy Solutions, Inc. has made any provisions for payment associated with injury as a result of participation. If you believe your child has been injured, or you have any questions about your child's participation in the study, or your child's rights as a research subject, you may contact any other principal investigators. Dr. Evans or Ms. Snyder's number is (407) 774-3141, and Dr. Johnston's number is (407) 865-9902. For information regarding your rights as a research participant, you may contact Chloe Rhamstine at 841-5111, extension 5837. Voluntary Participation You are free to refuse or stop participation in this research study at any time without penalty or loss of any healthcare benefits to which you are otherwise entitled. You are free to seek care from a physician of your choice at any time. SIGNATURE REQUIRED ON FOLLOWING PAGE

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Alternative Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Children Signatures 210 My signature indicates that I consent and authorize Ronald W Lynch, M.D.; Robert A Evans, Ph.D Bonnie J. Snyder M S., Ed.S. (Alternatives : A Center for Caring, Inc ) ; and Donna Johnston, N.D., C.H. (Healthy Solutions, Inc.) and whomever they may designate as their assistants to perform upon _____________________ (name of child) the research described above. If any unforeseen conditions arise in the course of the research calling in the Doctor s judgment for procedures in addition to or different from those planned I further request and authorize the Doctor to do whatever he deems advisable. I AM MAKING A DECISION WHETHER OR NOT TO HAVE MY CHILD PARTICIPATE IN THIS STUDY. I HAVE READ, OR HAD READ TO ME IN A LANGUAGE THAT I UNDERSTAND, ALL OF THE ABOVE, ASKED QUESTIONS, RECEIVED ANSWERS CONCERNING AREAS I DID NOT UNDERSTAND, AND WILLINGLY GIVE MY CONSENT FOR MY CHILD TO PARTICIPATE IN THIS STUDY. UPON SIGNING THIS FORM I WILL BE GIVEN A COPY Signature of Parent or Legal Representative Date Signature of Witness Date I have explained and defined in detail the research procedure in which the patient has consented to participate. Principal Investigator's Signature Date

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BIOGRAPHICAL SKETCH While completing his graduate studies at the University of Florida, Alan served as a practicum supervisor in the Department of Special Education and a research assistant in the Department of Medical Education. He was employed as the distance learning specialist for the Office of Continuing Medical Education. Alan also worked as an examiner for The Psychological Corporation, testing students for the Wechsler Individual Achievement Test-Second Edition standardization. Alan was active in his program and department. His activities included: Webmaster, Department of Foundations of Education; President and Past President, School Psychology Graduate Student Association; creator and Editor, School Psychology Times; co-creator, Foundations of Education Student Research Colloquium; Member-at-Large, American Psychological Association Student Science Council; organizer and program representative, University of Florida Student Affiliates in School Psychology (SASP) Chapter, American Psychological Association (Division 16); Program and Campus Representative, American Psychological Association of 260

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261 Graduate Students; and Scientist Pen-Pal, Science-By-Mail, Boston Museum of Science. Alan was named a 1998 Outstanding Young Man of America and was included in the 1999 Edition of Who's Who Among Students in American Universities and Colleges. He also received the 1999 University of Florida Presidential Recognition for outstanding achievement and contributions to the University. In the future, Alan plans to continue his research in the area of ADHD, particularly the use of neurofeedback as an alternative treatment. His other areas of research interest include the clinical applications of biofeedback, gifted education, and distance education.

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I certify that I have read this study and that in my opinion it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Doctor of Philosophy. Thomas Oakland, Chair Professor of Foundations of Education I certify that I have read this study and that in my opinion it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Doctor of Philosophy. Joh ranzler iate Professo of Foundations Education I certify that I have read this study and that in my opinion it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Doctor of Philosophy. Education I certify that I have read this study and that in my opinion it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Doctor of Philosophy.

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This dissertation was submitted to the Graduate Faculty of the College of Education and to the Graduate School and was accepted as partial fulfillment of the requirements for the degree of Doctor of Philosophy. August 1999 Chairman, Founaations of Education Dean, Graduate School

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