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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Yale University
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
Ohio State University
Columbus, Ohio, United States
Home Situations Questionnaire
Time frame: Week 24
Vineland Daily Living Skills Scale
Time frame: Week 24
Irritability subscale-Aberrant Behavioral Checklist
Time frame: Week 24
Clinical Global Impressions-Improvement (CGI-I)
Time frame: Week 24
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