Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00918567
First received: June 9, 2009
Last updated: June 10, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: atomoxetine
Behavioral: Behavior Modification Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • improvement in ADHD symptoms at school [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement in ADHD symptoms at home [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined therapy
atomoxetine plus behavior therapy
Drug: atomoxetine
open label treatment dosed up to 1.8mg/kg/day
Behavioral: Behavior Modification Therapy
8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group
Active Comparator: Drug therapy
atomoxetine alone
Drug: atomoxetine
open label treatment dosed up to 1.8mg/kg/day

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918567

Locations
United States, New York
Cennter for Children and Families
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Eli Lilly and Company
Investigators
Principal Investigator: James G Waxmonsky SUNY Buffalo
Principal Investigator: Daniel A Waschbusch SUNY Buffalo
  More Information

No publications provided by State University of New York at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Waschbusch PHD and James Waxmonsky MD (Co-PIs), Center for Children and Families SUNY Buffalo
ClinicalTrials.gov Identifier: NCT00918567     History of Changes
Other Study ID Numbers: B4Z-US-X053
Study First Received: June 9, 2009
Last Updated: June 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
ADHD
impact of atomoxetine with and and without behavior therapy at school and home

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014