2/3-Multisite RCT of Early Intervention for Spoken Communication in Autism

自闭症言语交流早期干预的 2/3 多站点随机对照试验

• 批准号: 7728939
• 负责人: TRISTRAM H SMITH
• 金额: $ 37.44万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-16 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7728939
• 关键词: 3 year old; 4 year old; Address; Adult; Affect; Age; Area; Autistic Disorder; Back; Behavior; Child; Child Support; Classification; Cognitive; Communication; Communities; Controlled Study; Development; Discrimination; Discrimination Learning; Disease; Early treatment; Educational Intervention; Educational process of instructing; Enrollment; Expectancy; Frequencies; Goals; Home environment; Hour; Impairment; Individual; Instruction; Intervention; Intervention Studies; Joints; Language; Language Development Disorders; Lead; Learning; Mediator of activation protein; Methods; Multi-Institutional Clinical Trial; National Institute of Mental Health; National Research Council; Nature; Nursery Schools; Outcome; Outcome Measure; Parents; Participant; Play; Process; Psyche structure; Psychological reinforcement; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Readiness; Recruitment Activity; Research; Research Personnel; Sampling; Schools; Site; Social Interaction; Stimulus; Structure; Symptoms; Testing; Training; Treatment outcome; base; comparative efficacy; data management; distraction; effective intervention; experience; flexibility; improved; intervention program; joint attention; mental age; primary outcome; programs; psychosocial; reinforcer; response; skills; social; social communication; standard of care; task analysis

DESCRIPTION (provided by applicant): While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials. The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, socialcommunicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts. Each site will recruit 64 children with autism (3-4 years of age; total sample=192) who are engaged in 25 hour per week early intervention programs. Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months. The primary aims are 1) to compare intervention conditions (DTT and IDA) on child outcomes of spoken language at the end of treatment and 6 months later, 2) to compare intervention conditions on child outcomes of core deficits of social features of autism at end of treatment and 6 months later, and 3) to examine potential moderators (e.g., mental age, language age) on treatment outcome. Secondary exploratory analyses focus on potential mediators (parent synchronization of joint attention and changes in parental expectancies), and non-specific factors (quality and quantity of community treatment). This study addresses multiple priorities in the autism research matrix (National Institute of Mental Health, 2004), including multisite RCTs of early intervention, isolation of active ingredients, identification of mediators or moderators, and treatment of core deficits.

描述（由申请人提供）：虽然在确定自闭症学龄前儿童的有效干预措施方面取得了重大进展（国家研究委员会，2001年），但很少有科学严格的研究比较了这些干预措施的积极成分，或者检查了针对核心缺陷的结果。为了满足这些需求，这个合作的多站点项目结合了在随机对照临床试验（RCT）中经历的研究人员的专业知识，研究了自闭症幼儿的核心缺陷，数据管理以及对多站点临床试验的分析。 The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement,社会通信的参与方法在社会有效的沟通环境中对共同关注，象征性游戏以及常规符号的使用。每个站点将招募64名自闭症儿童（3-4岁；总样本= 192），他们每周25小时早期干预计划。儿童将随机分配给DTT或IDA。在每种情况下，儿童正在进行的早期干预计划将每天进行两次30分钟的研究干预措施（DTT或IDA），由监督治疗师进行4个月，并过渡到家庭治疗2个月。主要目的是1）在治疗结束时和6个月后的口语儿童结果（DTT和IDA）比较干预条件（DTT和IDA），2），2），以比较治疗结束时自闭症的核心社会特征核心缺陷的干预条件，以及6个月后和3个月后的3个月，以及3个），以检查潜在的调节剂（例如，心理年龄，语言年龄，语言年龄）。次要探索性分析的重点是潜在的介体（父母对关注的关注和父母预期的变化）和非特异性因素（社区治疗的质量和数量）。这项研究涉及自闭症研究矩阵（国家心理健康研究所，2004年）的多个优先事项，包括早期干预的多站点RCT，主动成分的隔离，介体或主持人的鉴定以及核心缺陷的治疗。