RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders

Study Overview
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Brief Summary
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This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.

Detailed Description
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PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed. Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4 will be offered an alternative mediation treatment, aripiprazole. These participants will remain in their original treatment group (either med alone or med plus parent management training). After 6 months of treatment (Week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment (This phase of the study was ended in Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.

Official Title
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Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Conditions
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Child Development Disorders, Pervasive

Intervention / Treatment
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* Drug: Risperidone
* Behavioral: Behavior Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified Weight > 30 lbs IQ >= 35 or mental age of at least 18 months Exclusion Criteria: Psychotic Disorder History of intolerance or nonresponse to risperidone Pregnancy History of neuroleptic malignant syndrome

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: risperidone plus parent management training<br> | Drug: Risperidone<br> <br> Behavioral: Behavior Therapy<br> <br> |
| Active Comparator: risperidone only<br> | Drug: Risperidone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Situations Questionnaire |  | Week 24 | 
| Vineland Daily Living Skills Scale |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritability subscale-Aberrant Behavioral Checklist |  | Week 24 | 
| Clinical Global Impressions-Improvement (CGI-I) |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autistic Disorder, Asperger Syndrome