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

描述（由申请人提供）：虽然在确定学龄前自闭症儿童的有效干预措施方面取得了重大进展（国家研究理事会，2001年），但很少有科学严谨的研究比较这些干预措施的活性成分或检查核心缺陷的结果。为了满足这些领域的需求，这个合作的多中心项目结合了在随机对照临床试验（RCT），自闭症幼儿核心缺陷研究以及多中心临床试验数据管理和分析方面经验丰富的研究人员的专业知识。本研究的目的是比较两种干预措施对改善口语和减少自闭症症状的效果：（1）离散试验训练（DTT）--一种应用行为分析方法，强调高度结构化的入学准备技能教学（匹配样本，模仿，功能游戏，接受和表达语言）和（2）人际发展的方法（IDA）：视觉支持，以儿童为中心，灵活的参与，socialcommunicative参与方法，共同注意，符号游戏，以及在社会有效的沟通环境中使用传统符号。每个研究中心将招募64名自闭症儿童（3-4岁;总样本=192），他们每周参加25小时的早期干预计划。儿童将被随机分配到DTT或IDA。在每种情况下，儿童正在进行的早期干预计划将通过每天两次30分钟的研究干预（DTT或IDA）来加强，由监督治疗师进行4个月，过渡到家庭治疗2个月。主要目的是1）比较干预条件（DTT和IDA）对治疗结束时和6个月后儿童口语结果的影响，2）比较治疗结束时和6个月后自闭症社会特征核心缺陷儿童结果的干预条件，以及3）检查潜在的调节因素（例如，心理年龄、语言年龄）对治疗结果的影响。二次探索性分析集中在潜在的介质（父母同步的联合注意力和父母的期望值的变化），和非特异性因素（社区治疗的质量和数量）。这项研究解决了自闭症研究矩阵（国家精神卫生研究所，2004年）中的多个优先事项，包括早期干预，分离活性成分，鉴定介质或调节剂，以及治疗核心缺陷的多中心RCT。

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.