1/5-Randomized Trial of Parent Training for Young Children with Autism

自闭症幼儿家长培训的 1/5 随机试验

• 批准号: 7783088
• 负责人: Lawrence D. Scahill
• 金额: $ 44.79万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 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/7783088
• 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; 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

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)：自闭症是一种儿童早期发病的状况，以社交延迟、交流延迟和重复行为为特征，每1000名儿童中就有2名受到影响(Fombonne，2003)。如果包括更广泛的范围(PDD-NOS和阿斯伯格障碍)，患病率为每1000名儿童中有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(PDDS)的严重性和流行率，它对公众健康有巨大的影响。人们普遍认为，学龄前干预可以减少PDD的长期残疾，但这些计划所需的组成部分和最佳强度仍然不清楚(国家研究委员会，2001)。此外，并不是所有社区都能为患有PDD的幼儿提供推荐的行为和教育治疗(Lord等人，2005年)。此外，学龄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，尽管父母作为治疗团队中的合作伙伴的作用得到了普遍承认，但很少有研究测试以父母为基础的干预措施，而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站点研究，以比较父母培训和心理教育对180名患有PDD的学龄前儿童的影响。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)。主要结果是父母对孩子易怒和不服从行为的评价发生了变化。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一名对治疗分配视而不见的评分员进行评估。亲子互动将在半结构化的实验序列中由盲评分员进行评估。PT对父母压力的影响以及同时干预的可能的缓和效果也将被探索。培训和质量保证服务将跨网站共享；耶鲁大学将提供数据管理和统计服务。这一应用与NIMH咨询委员会(自闭症心理社会和行为干预研究)的建议是一致的，该委员会呼吁进行大规模的随机试验，以评估PDD儿童的心理社会干预的有效性并促进其传播(Lord等人，2005年；Smith等人，2007年)。为了进行这项研究，我们召集了一个由经验丰富的研究人员组成的财团，他们来自领先的自闭症研究项目，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。这些中心在进行多点试验(例如，儿童精神药理学研究单位(RUPP)自闭症网络)和为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、方法严谨的研究，以开发针对自闭症儿童的循证干预措施。这项试验旨在通过提供关于教育父母成为有效教师和幼儿倡导者的最佳做法的信息来满足这一需要。