RISPERIDONE AND BEHAVIOR THERAPY IN CHILDREN AND ADOLESCENTS WITH PERVASIVE D

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pervasive Developmental Disorders (PDD) are serious developmental conditions affecting 6 per 1000 in school-age children. We propose a multi-site study in which 120 children with PDD accompanied by tantrums, aggression, and/or self-injury will be randomly assigned to risperidone only (N=40) or risperidone plus a structured parent management training program (PMT) (N=80) and then compared on adaptive and behavioral outcomes after 8 and 24 weeks of treatment. At the 8-week mark all subjects will be classified as a responder or non-responder by an independent evaluator (blind to treatment assignment). Children who are classified as non-responders will be offered an opportunity to receive treatment with an alternative medication called aripirazole. Children who go on aripirazole will continue in their originally assigned groups (medication only or medication plus PMT) for up to 16 more weeks. At the 24-week mark (6 months of treatment total), children who demonstrate a positive response to either medication only (risperidone or aripirazole) or the combination of medication plus PMT(estimated sample size of 60) will be gradually tapered off the medication over 10 more weeks. The goal of the discontinuation phase is to compare the rate of relapse (i.e., return of tantrums, aggression and/or self-injury) across the two groups (medication only versus medication plus PMT). The justification for the inclusion of children and adolescents with PDD is based on the observation that PDD can be a serious disability across social, emotional, and academic domains. Thus, there is a pressing need for new treatments in PDD that are safe and effective.