RISPERIDONE AND BEHAVIOR THERAPY IN CHILDREN AND ADOLESCENTS WITH PERVASIVE D

利培酮和行为治疗在患有普遍 D 的儿童和青少年中的应用

• 批准号: 7717517
• 负责人: Christopher J McDougle
• 金额: $ 0.34万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717517
• 关键词: Adolescent; Affect; Aggressive behavior; Behavior Therapy; Behavioral; Child; Combination Medication; Computer Retrieval of Information on Scientific Projects Database; Condition; Development; Emotional; Funding; Goals; Grant; Institution; Outcome; Parents; Pervasive Development Disorder; Pharmaceutical Preparations; Phase; Randomized; Rate; Relapse; Research; Research Personnel; Resources; Risperidone; Sample Size; School-Age Population; Self-Injurious Behavior; Site; Source; Structure; Training Programs; United States National Institutes of Health; Week; base; blind; disability; response; social

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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 普及性发育障碍(PDD)是一种严重的发育疾病，学龄儿童中每1000人中就有6人受到影响。我们提出了一项多点研究，其中120名伴有发脾气、攻击和/或自我伤害的PDD儿童将被随机分配到单纯利培酮组(N=40)或利培酮加结构化父母管理培训计划(PMT)组(N=80)，然后在治疗8周和24周后比较适应和行为结果。在8周时，所有受试者将被独立评估者归类为应答者或无应答者(对治疗分配视而不见)。被归类为无反应的儿童将有机会接受名为阿立哌唑的替代药物治疗。服用阿立哌唑的儿童将继续在他们最初分配的组中(单纯用药或药物加PMT)多呆16周。在24周(总共治疗6个月)时，对单独用药(利培酮或阿立哌唑)或药物加PMT(估计样本量为60)呈阳性反应的儿童将在10周后逐步停药。停药阶段的目标是比较两组(单纯药物治疗和药物加PMT)的复发率(即再次发脾气、攻击和/或自我伤害)。将患有PDD的儿童和青少年包括在内的理由是基于这样的观察，即PDD可以是一种跨越社会、情感和学术领域的严重残疾。因此，迫切需要安全有效的治疗PDD的新方法。