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

说明(由申请人提供)：虽然在确定对患有自闭症的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有效成分或检查侧重于核心缺陷的结果。为了解决这些领域的需求，这个合作的多地点项目结合了在随机对照临床试验(RCT)、自闭症儿童核心缺陷研究以及多地点临床试验的数据管理和分析方面经验丰富的研究人员的专业知识。本项目的目标是比较两种干预措施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，强调高度结构化的教学准备技能(匹配到样本、模仿、功能游戏、接受性和表达语言)和(2)人际发展方法(IDA)：一种视觉支持的、以儿童为中心的、灵活的参与、关于联合注意、象征性游戏的社交参与方法，以及在社会有效的交流环境中使用传统符号。每个站点将招募自闭症儿童(3-4岁，总样本=192人)，他们从事每周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得到加强，由监督治疗师进行为期4个月的每天两次30分钟的研究干预(DTT或IDA)，并过渡到2个月的家庭治疗。主要目的是1)比较干预条件(DTT和IDA)对治疗结束和6个月后儿童口语的影响，2)比较治疗结束和6个月后自闭症社会特征核心缺陷对儿童结果的干预条件，以及3)研究潜在的调节因素(例如心理年龄、语言年龄)对治疗结果的影响。次级探索性分析侧重于潜在的中介因素(父母共同注意的同步性和父母期望的变化)，以及非特定因素(社区治疗的质量和数量)。这项研究涉及自闭症研究矩阵中的多个优先事项(国家精神卫生研究所，2004年)，包括早期干预的多点随机对照试验、有效成分的分离、调节剂或调节剂的确定以及核心缺陷的治疗。

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.