3/4: Improving the Part C Early Intervention Service Delivery System for Children with ASD: A Randomized Clinical Trial

项目总结 尽管有强烈的共识认为，对自闭症谱系障碍儿童进行早期、专门的干预 (ASD)会对结果产生重大影响，美国卫生系统提供此类服务的能力是 自闭症患病率的迅速上升给我们带来了严峻挑战。长期目标是改善以下方面的结果 通过增加提供适当专门治疗的能力，为患有自闭症早期症状的儿童提供 在现有基础设施内：C部分早期干预(EI)服务交付系统。C部分是公开的 为所有领域提供资金，并为发育迟缓或残疾的3岁以下儿童提供服务。 目前，EI服务的有效性受到实践差异较大和证据使用频率较低的限制- 以干预为基础。这项研究的目标是改善对有早期症状的儿童的服务和结果 通过进行随机对照试验(RCT)来测试培训EI提供者的有效性 提供互惠模仿培训(RIT)。RIT是一种自然主义发展行为干预(NDBI) 这非常适合EI设置，因为它是低强度的、基于游戏的、易于学习和实施的，以及 可教给家庭独立使用，从而增加干预剂量。 该RCT将采用混合类型1有效性/实施设计，并将使用独特的混合 方法收集证据，这将是大规模实施RIT的关键，等待积极试验 结果。样本包括美国4个州的20家企业信息机构，总共包括160家企业信息提供商 以及440个有ASD早期症状的儿童家庭，这不仅提供了强大的样本量，而且 还提供了评估此方法在不同区域的通用性的机会 C部分服务的实施。EI提供者将被随机分配到RIT训练组(n=80)或 按常规治疗(TAU；n=80)。这两个组的提供者都将在他们的工作量中确定2-5名儿童 年龄16~30个月，有ASD早期症状的儿童(每组220例)。密集的、最先进的、多个 将使用方法评估技术来衡量干预对儿童语言的影响 和社交，以及父母的自我效能感和幸福感。重要的是，这项研究将检查 假定机制(即，儿童在模仿和共同注意中获得；父母或有反应) 通过它，干预改善了临床相关的结果。有关提供商发起的数据 将分析对干预和交付的修改，以确定保真度-一致性与保真度- 不一致的变化，这将有助于完善未来的RIT培训和质量保证程序。在……里面 总之，这项研究将产生大规模实施RIT所需的证据，从而增加 现有的企业信息系统向快速增长的 出现自闭症早期症状的儿童人口。

PROJECT SUMMARY Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the U.S. health system’s capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The long-term goal is to improve outcomes for children with early signs of ASD by increasing the capacity to provide appropriately specialized treatment within an existing infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available in all areas, and serves children under age 3 who have developmental delays or disabilities. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence- based interventions. The study objective is to improve services and outcomes for children with early signs of ASD by conducting a randomized controlled trial (RCT) testing the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT). RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. This RCT will employ a hybrid type 1 effectiveness/implementation design, and will use a unique mixed methods approach to gather evidence that will be essential for implementing RIT at scale, pending positive trial results. The sample includes 20 EI agencies across 4 U.S. States and comprises a total of 160 EI providers and 440 families of children with early symptoms of ASD, which not only provides a robust sample size, but also affords the opportunity to assess generalizability of this approach across regions that vary in their implementation of Part C services. EI providers will be randomly assigned to the RIT training group (n=80) or treatment as usual (TAU; n=80). Providers in both groups will identify 2-5 children in their caseload who are 16-30 months old with early symptoms of ASD (n=220 children per group). Intensive, state-of-the art, multi- method assessment technology will be used to measure the impact of the intervention on children’s language and social communication, as well as parents’ self-efficacy and well-being. Importantly, this study will examine putative mechanisms (i.e., child gains in imitation and joint attention; parent contingent responsiveness) through which the intervention improves clinically-relevant outcomes. Data regarding provider-initiated modifications to the intervention and delivery will be analyzed to identify fidelity-consistent vs. fidelity- inconsistent changes, which will inform refinement of future RIT training and quality assurance procedures. In sum, this study will generate the evidence necessary to implement RIT at scale, thereby increasing the capacity of the existing EI system to deliver effective, evidence-based intervention to the rapidly growing population of children who show early signs of ASD.