2/5-Randomized Trial of Parent Training for Young Children with Autism

自闭症幼儿家长培训的 2/5 随机试验

基本信息

批准号：
7783408
负责人：
LUC LECAVALIER
金额：
$ 23.01万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-01-15 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7783408
关键词：
7 year old Accountability Address Advocate Affect Aftercare Age Aggressive behavior Agreement Aman Amendment Arts Asperger Syndrome Attention Authorship Autistic Disorder Behavior Behavior Therapy Behavioral Biometry Blinded Budgets Bylaw Child Child Behavior Childhood Chronic Clinical Clinical Trials Data Monitoring Committees Clinical Trials Design Collaborations Communication Communities Consensus Data Data Analyses Data Quality Decision Making Development Developmental Disabilities Diagnosis Educational process of instructing Effectiveness Enrollment Ensure Evidence based intervention Explosion Faculty Family Funding Genetic Government Home environment Hour Hyperactive behavior Indiana Informatics Information Systems Intervention Intervention Trial Laboratories Language Language Tests Laws Leadership Left Letters Life Manuals Measurement Measures Mental disorders Methods Methylphenidate Monitor NIH Program Announcements National Institute of Mental Health National Research Council Neurobiology Newly Diagnosed Nursery Schools Ohio Outcome Outcome Assessment Paper Parent-Child Relations Parenting Education Parenting behavior Parents Pediatric Hospitals Pervasive Development Disorder Phase Policies Population Positioning Attribute Positive Reinforcements Postdoctoral Fellow Preschool Child Prevalence Principal Investigator Problem behavior Procedures Program Reviews Protocols documentation Psychiatry Psychologist Psychopharmacology Public Health Publications Quality Control Questionnaires Random Allocation Randomized Recommendation Recording of previous events Records Reporting Research Research Ethics Committees Research Personnel Risperidone Role Safety School-Age Population Self-Injurious Behavior Series Services Severities Site Site Visit Soaps Socialization Solid Specialized Center Specific qualifier value Stress Structure Study Subject Supervision System Techniques Teleconferences Testing Therapeutic Intervention Time TimeLine Training Training Programs United States National Institutes of Health Universities Variant Video Recording Visit Vulnerable Populations Work Writing age group analog autism spectrum disorder base blind clinical practice data management design developmental disease disability early childhood effective therapy evidence base experience follow up assessment impression improved indexing interest meetings non-compliance operation parental role primary outcome programs psychoeducation psychoeducational intervention psychosocial public health relevance publication formats quality assurance randomized trial response skills social social communication statistical service teacher therapy development web based interface

项目摘要

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. PUBLIC HEALTH RELEVANCE: There is an urgent need for large-scale, methodologically rigorous studies to develop evidence-based interventions for children with autism. This trial is designed to address this need by providing information on optimal practices for educating parents to be effective teachers and advocates for their young children.

描述（由申请人提供）：自闭症是一种以社交迟缓、沟通迟缓和重复行为为特征的儿童早期发病状况，每 1,000 名儿童中就有 2 人受到影响（Fombonne，2003 年）。如果包括更广泛的范围（PDD-NOS 和阿斯伯格症），患病率为每 1000 名儿童 67 例（自闭症和发育障碍监测网络，2007 年）。鉴于广泛性发育障碍（PDD）的严重性和患病率，它对公共健康具有巨大的影响。人们普遍认为，学龄前阶段的干预可以减少 PDD 的长期残疾，但这些计划所需的组成部分和最佳强度仍不清楚（国家研究委员会，2001）。此外，并非所有社区都为患有 PDD 的幼儿提供推荐的行为和教育治疗（Lord 等，2005）。此外，学前干预通常集中在孩子身上（Smith，1999），让父母自己管理孩子的行为（Jacobson＆Mulick，2000）。因此，尽管父母在治疗团队中作为合作伙伴的作用得到了普遍认可，但很少有研究测试基于父母的干预措施，而且大规模的干预措施也不存在（Smith 等，2007）。为了响应 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），本申请描述了一项五中心研究，对 180 名学龄前儿童进行家长培训与心理教育进行比较PDD。符合条件的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)。主要结果是父母评价的孩子的烦躁和不顺从行为的改变。适应性功能（社交、沟通和日常生活技能领域）的整体改善和收益将由不了解治疗分配的评估者进行评估。亲子互动将由盲评员在半结构化实验室序列中进行评估。还将探讨 PT 对父母压力的影响以及同时干预措施可能产生的调节作用。培训和质量保证服务将在各个地点共享；耶鲁大学将提供数据管理和统计服务。该申请与 NIMH 咨询委员会（自闭症心理社会和行为干预研究）的建议一致，该委员会呼吁开展大规模随机试验来评估 PDD 儿童心理社会干预措施的有效性并促进其传播（Lord 等人） .，2005；史密斯等人，2007）。为了进行这项研究，我们召集了来自领先的自闭症研究项目的经验丰富的研究人员组成的联盟，这些研究项目包括耶鲁大学、罗切斯特大学、匹兹堡大学、俄亥俄州立大学和印第安纳大学。这些中心在进行多中心试验（例如，儿科精神药理学研究单位（RUPP）自闭症网络）和对自闭症儿童进行育儿培训方面拥有丰富的经验。公共卫生相关性：迫切需要进行大规模、方法论严谨的研究，为自闭症儿童制定循证干预措施。该试验旨在通过提供有关教育父母成为有效的教师和幼儿倡导者的最佳实践的信息来满足这一需求。