Conditions: Autism Pervasive Development Disorder Asperger's Disorder Attention Deficit Hyperactivity Disorder
Keywords: Autism PDD NOS Attention Deficit Hyperactivity Disorder Parent Management Training
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.

Detailed description:

Arms:
arm 1: Atomoxetine + Parent Management Training arm 2: Atomoxetine without Parent Management Training arm 3: Placebo + Parent Management Training arm 4: Placebo without Parent Management Training

Interventions: intervention 1: atomoxetine intervention 2: Placebo intervention 3: Parent Management Training
Intervention descriptions: intervention 1: atomoxetine intervention 2: Placebo + parent management treatment intervention 3: None

Protocol document: