Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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).
    

Intervention name(s): atomoxetine; Behavior Modification Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): open label treatment dosed up to 1.8mg/kg/day; 8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group
Other intervention name(s): Drug Therapy; Behavior Therapy
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Atomoxetine; Behavior Therapy