5/5-Randomized Trial of Parent Training for Young Children with Autism

描述（由申请人提供）：自闭症是一种以社交延迟、沟通延迟和重复行为为特征的儿童早期发病状况，每1,000名儿童中有2名患有自闭症（Fombonne，2003）。如果包括更广泛的范围（PDD-NOS和Alfreger障碍），患病率为每1000名儿童67人（自闭症和发育障碍监测网络，2007年）。鉴于广泛性发育障碍的严重性和患病率，它对公共卫生有着巨大的影响。人们普遍认为，学龄前干预可以减少PDD的长期残疾，但这些方案的必要组成部分和最佳强度仍不清楚（国家研究理事会，2001年）。此外，对于患有PDD的幼儿推荐的行为和教育治疗并非在所有社区都可用（Lord等人，2005年）。此外，学前干预往往集中在儿童（史密斯，1999年）离开父母自己管理孩子的行为（雅各布森和穆里克，2000年）。因此，尽管父母作为治疗团队中的合作伙伴的作用得到普遍认可，但很少有研究测试了基于父母的干预措施，并且不存在大规模干预措施（Smith等人，2007年）。作为对PA 07 - 092（精神障碍协作R01）和PA 07 - 085（自闭症和自闭症谱系障碍研究）的回应，本申请描述了一项五个地点的研究，以比较180名学龄前PDD儿童的父母培训与心理教育。合格受试者将被随机分配接受为期6个月的家长培训（PT）或心理教育干预（PEP）。主要结果是父母评定的孩子易怒和不顺从行为的变化。将由对治疗分配不知情的评定者评估适应功能（社交、沟通和日常生活技能领域）的总体改善和增益。将由设盲的评估者在半结构化实验室序列中评估亲子互动。PT对父母压力的影响以及同时干预的可能调节作用也将被探讨。培训和质量保证服务将在各研究中心共享;耶鲁大学将提供数据管理和统计服务。该申请与NIMH咨询理事会（自闭症心理社会和行为干预研究）的建议一致，该建议要求进行大规模随机试验，以评估PDD儿童中心理社会干预的疗效并促进其传播（Lord等人，2005; Smith等人，2007年）。为了进行这项研究，我们组建了一个由来自领先自闭症研究项目的经验丰富的研究人员组成的联盟，这些项目包括耶鲁大学、罗切斯特大学、匹兹堡大学、俄亥俄州州立大学和印第安纳州大学。这些中心在开展多中心试验方面具有丰富的经验（例如，儿童精神药理学研究单位（RUPP）自闭症网络）和自闭症儿童的父母培训。

DESCRIPTION (provided by applicant): Autism is a condition of early childhood onset marked by social delay, communication delay and repetitive behavior affecting 2 per 1,000 children (Fombonne, 2003). If the wider spectrum is included (PDD-NOS and Asperger's disorder), the prevalence is 67 per 1000 children (Autism and Developmental Disorders Monitoring Network, 2007). Given the severity and the prevalence, pervasive developmental disorders (PDDs) have enormous public health impact. There is general agreement that intervention in the preschool years can reduce the long-term disability of PDD, but the required components and optimal intensity of these programs remain unclear (National Research Council, 2001). In addition, recommended behavioral and educational treatments for young children with PDD are not available in all communities (Lord et al., 2005). Moreover, preschool interventions often focus on the child (Smith, 1999) leaving parents to manage the child's behavior on their own (Jacobson & Mulick, 2000). Thus, although the role of parents as partners in the treatment team is universally acknowledged, few studies have tested parent-based interventions and large-scale interventions are non-existent (Smith et al., 2007). In response to PA 07-092 (Collaborative R01s for Mental Disorders) and PA 07-085 (Research on Autism and Autism Spectrum Disorders), this application describes a five-site study to compare parent training to psychoeducation in 180 preschool-age children with PDD. Eligible subjects will be randomly assigned to receive either Parent Training (PT) or Psychoeducational Intervention (PEP) over 6 months. The primary outcomes are the change in the child's irritable and noncompliant behavior rated by the parent. Overall improvement and gains in adaptive functioning (social, communication and daily living skill domains) will be assessed by a rater who is blind to treatment assignment. Parent-child interaction will be assessed in a semi-structured lab sequence by blinded raters. The effects of PT on parental stress and the possible moderating effects of concurrent interventions will also be explored. Training and quality assurance services will be shared across sites; Yale University will provide data management and statistical services. This application is congruent with recommendations of an NIMH advisory council (Research in Psychosocial and Behavioral Interventions in Autism), which called for large-scale, randomized trials to evaluate the efficacy and promote the dissemination of psychosocial interventions in children with PDD (Lord et al., 2005; Smith et al., 2007). To conduct this study, we have assembled a consortium of experienced investigators from leading autism research programs including Yale, University of Rochester, University of Pittsburgh, Ohio State University, and Indiana University. These centers have extensive experience with conducting multisite trials (e.g., Research Units on Pediatric Psychopharmacology (RUPP) Autism Network) and with parenting training for children with autism.