Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 10/14/2017 |
| Start Date: | January 2007 |
| End Date: | May 2008 |
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there
is only one published study specifically designed to evaluate its efficacy in school
settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3
mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However,
children are typically referred for treatment because of "real life" problems in functioning,
not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce
functional improvements at home, the Weiss study found limited results in this area at
school.
Furthermore, almost no research has examined the effects of combining ATX and behavior
therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of
hyperactivity/impulsivity and increased the number of subjects reaching optimal response
(Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve
functional performance in the classroom. The effects of combined therapy may be even larger
for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.
Objective: The primary objective was to evaluate the effects of ATX alone and in combination
with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed
using traditional symptoms measures as well as functional measures of academic and behavioral
improvements in the classroom.
is only one published study specifically designed to evaluate its efficacy in school
settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3
mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However,
children are typically referred for treatment because of "real life" problems in functioning,
not symptoms (Pelham, Fabiano, & Massetti, 2005). While ATX has been found to produce
functional improvements at home, the Weiss study found limited results in this area at
school.
Furthermore, almost no research has examined the effects of combining ATX and behavior
therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of
hyperactivity/impulsivity and increased the number of subjects reaching optimal response
(Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve
functional performance in the classroom. The effects of combined therapy may be even larger
for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.
Objective: The primary objective was to evaluate the effects of ATX alone and in combination
with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed
using traditional symptoms measures as well as functional measures of academic and behavioral
improvements in the classroom.
The objectives were evaluated in an 8 week open label trial of where half of the participants
were randomly assigned to receive (ATX+BT) while the rest received only ATX. An open label
design was employed as the efficacy of ATX for ADHD symptoms has been established and to
ensure that all patients received at least one active treatment. Parents in the ATX+BT group
attended an eight week parenting course using the Community Oriented Parent Education (COPE)
program (Cunningham, Bremner, & Secord, 1998) while the child participated in an eight week
social skills course. Teachers implemented a Daily Report Card (DRC) to track classroom
behaviors. In the BT group, the child's DRC performance was communicated daily to parents and
tied to consequences at home and school. In the ATX group, parents were not provided with the
DRCs. The ATX dosing protocol was as follows: .5mg/kg per day on days 1-3, .8mg/kg/day days
4-7, 1.2mg/kg days 8+. After 3 weeks, subjects were eligible to increase to 1.8mg/kg/day. ATX
was dosed once in the morning but could be dosed BID to address tolerability. The mean final
dose was 1.4mg/kg/day.
To be enrolled, children must have had an IQ > 75, not failed a trial of ATX, met DSM
criteria for ADHD but not other psychiatric comorbidities except ODD/CD and be in good
physical health. Children already taking ADHD medication were enrolled only if the average
symptom score on the ADHD subscale of the Disruptive Behaviors Disorders (DBD) scale was >2
(moderate impairment). ADHD was confirmed by parent report on the DISC and the DBD, which
rates all DSM 3R and IV symptoms of ODD, CD and ODD on a 0-3 likert scale. Subjects were also
required to evidence ADHD symptoms in the classroom as rated on the IOWA Conners. Psychiatric
comorbidities were assessed using the DISC.
Measures of treatment response included:
1. Parents and teacher ratings on the IOWA Conners: 10 item Likert ratings to measure
children's inattention-overactive-impulsive and oppositional-defiant behavior (Milich,
Loney, & Landau, 1982)
2. Parent and teacher ratings on the Impairment Rating Scale (IRS): 8 items using
visual-analogue scales to measure children's functional impairment in peer
relationships, adult-child relationships, academic performance, classroom behavior, and
self esteem (Fabiano et al., 2006).
3. Parent and teacher side effect ratings using a structured list of common side effects
seen with ATX modeled after the Pittsburgh Side Effects Rating Scale (Pelham, 1993).
4. Direct observations of subjects to measure rule violations and on/off task behavior
using a modified version of the COCADD system (Atkins, Pelham & Licht, 1988) in which
trained observers watched children in their classroom for 30 minutes, recording each
rule violation and off-task behavior.
5. Parent and teacher rating on the Social Skills Rating Scale (SSRS): a measure of
teachers' and parents perceptions of children's social and academic skills and of their
overall problem behaviors (Gresham & Elliott, 1990).
were randomly assigned to receive (ATX+BT) while the rest received only ATX. An open label
design was employed as the efficacy of ATX for ADHD symptoms has been established and to
ensure that all patients received at least one active treatment. Parents in the ATX+BT group
attended an eight week parenting course using the Community Oriented Parent Education (COPE)
program (Cunningham, Bremner, & Secord, 1998) while the child participated in an eight week
social skills course. Teachers implemented a Daily Report Card (DRC) to track classroom
behaviors. In the BT group, the child's DRC performance was communicated daily to parents and
tied to consequences at home and school. In the ATX group, parents were not provided with the
DRCs. The ATX dosing protocol was as follows: .5mg/kg per day on days 1-3, .8mg/kg/day days
4-7, 1.2mg/kg days 8+. After 3 weeks, subjects were eligible to increase to 1.8mg/kg/day. ATX
was dosed once in the morning but could be dosed BID to address tolerability. The mean final
dose was 1.4mg/kg/day.
To be enrolled, children must have had an IQ > 75, not failed a trial of ATX, met DSM
criteria for ADHD but not other psychiatric comorbidities except ODD/CD and be in good
physical health. Children already taking ADHD medication were enrolled only if the average
symptom score on the ADHD subscale of the Disruptive Behaviors Disorders (DBD) scale was >2
(moderate impairment). ADHD was confirmed by parent report on the DISC and the DBD, which
rates all DSM 3R and IV symptoms of ODD, CD and ODD on a 0-3 likert scale. Subjects were also
required to evidence ADHD symptoms in the classroom as rated on the IOWA Conners. Psychiatric
comorbidities were assessed using the DISC.
Measures of treatment response included:
1. Parents and teacher ratings on the IOWA Conners: 10 item Likert ratings to measure
children's inattention-overactive-impulsive and oppositional-defiant behavior (Milich,
Loney, & Landau, 1982)
2. Parent and teacher ratings on the Impairment Rating Scale (IRS): 8 items using
visual-analogue scales to measure children's functional impairment in peer
relationships, adult-child relationships, academic performance, classroom behavior, and
self esteem (Fabiano et al., 2006).
3. Parent and teacher side effect ratings using a structured list of common side effects
seen with ATX modeled after the Pittsburgh Side Effects Rating Scale (Pelham, 1993).
4. Direct observations of subjects to measure rule violations and on/off task behavior
using a modified version of the COCADD system (Atkins, Pelham & Licht, 1988) in which
trained observers watched children in their classroom for 30 minutes, recording each
rule violation and off-task behavior.
5. Parent and teacher rating on the Social Skills Rating Scale (SSRS): a measure of
teachers' and parents perceptions of children's social and academic skills and of their
overall problem behaviors (Gresham & Elliott, 1990).
Inclusion Criteria:
1. meet DSM-IV diagnostic criteria for ADHD-combined type;
2. estimated IQ of 75 or higher;
3. agree to comply with the randomly assigned treatment condition;
4. enrolled in full time school at first grade level or higher; AND
5. have a primary teacher available to complete ratings for the entire study duration.
Exclusion Criteria:
1. current or past history of seizures (not including benign febrile seizures) or other
neurological disorders;
2. physical conditions that preclude administration of Strattera or other medical illness
that might confound study results or increase the safety risk to subjects exposed to
study treatments (i.e. marked cardiac conduction delay, etc.);
3. prior failed trial of Strattera defined as 3 weeks or more on a daily dose of
Strattera of at least .8mg/kg or a documented inability to tolerate at least
.8mg/kg/day;
4. serious forms of psychopathology other than ADHD, such autism, bipolar disorder,
schizophrenia or any other psychopathology requiring urgent treatment with
psychotropic medication; OR
5. children for whom discontinuation of their current psychotropic medication would
represent a serious risk to themselves or others.
The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning
disabilities will not result in exclusion from the study as they are commonly occurring
comorbidities that have not been found to moderate response to ADHD treatments (Jensen et
al., 2001). Enrollment in special education services will also not be an exclusionary
criteria as work by this research group has found that such services do not affect response
to ADHD treatments (Niemic, Fabiano, Pelham, & Fuller, 2002).
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