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

4/4：完善 ASD 儿童 C 部分早期干预服务提供系统：随机临床试验

• 批准号: 10331421
• 负责人: Alice S. Carter
• 金额: $ 4.4万
• 依托单位: UNIVERSITY OF MASSACHUSETTS BOSTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10331421
• 关键词: Address; Aftercare; Age; Area; Behavior; Behavior Therapy; Birth; Characteristics; Child; Child Language; Child Rearing; Code; Consensus; Consultations; Data; Development; Developmental Delay Disorders; Developmental Disabilities; Disabled Persons; Early Intervention; Education; Effectiveness; Evidence based intervention; Family; Family member; Funding; Future; Goals; Health system; Heterogeneity; Home; Hybrids; Infrastructure; Intervention; Interview; Language; Language Development; Lead; Learning; Life; Measures; Mediating; Methods; Modification; Motor; National Institute of Mental Health; Outcome; Parents; Patient Self-Report; Personal Satisfaction; Play; Population; Prevalence; Procedures; Protocols documentation; Provider; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Role; Sample Size; Sampling; Self Efficacy; Services; Site; Source; Stress; Structure; Sum; Symptoms; System; Technology Assessment; Testing; Time; Training; Variant; acceptability and feasibility; autism spectrum disorder; autistic children; base; clinically relevant; data management; dosage; economic cost; effectiveness implementation design; effectiveness implementation study; effectiveness testing; evidence base; follow-up; hybrid type 1 design; implementation determinants; implementation evaluation; improved; improved outcome; innovation; intervention program; joint attention; language outcome; member; multi-site trial; provider intervention; quality assurance; service delivery; service intervention; social communication; treatment as usual; treatment effect

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.

项目摘要 尽管对自闭症谱系障碍儿童的早期专门干预 (ASD)可能对结果产生巨大影响，美国卫生系统提供此类服务的能力 ASD患病率迅速上升的严峻挑战。长期目标是改善结果， 通过提高提供适当专门治疗的能力， 在现有的基础设施内：C部分早期干预（EI）服务提供系统。C部分公开 该基金提供资金，在所有地区提供，为3岁以下发育迟缓或残疾儿童提供服务。 目前，EI服务的有效性受到高度实践差异和不经常使用证据的限制- 基于干预。该研究的目标是改善患有早期症状的儿童的服务和结果 ASD通过进行随机对照试验（RCT）测试培训EI提供者的有效性， 交互式模仿训练（Reciprocal Imitation Training，RIT）RIT是一种自然发展行为干预（NDBI） 这是非常适合EI设置，因为它是低强度，播放为基础，易于学习和实施， 可教给家庭独立使用，增加干预剂量。 该RCT将采用混合型1有效性/实施设计，并将使用独特的混合型 方法方法收集证据，这将是必要的实施RIT的规模，等待积极的试验 结果样本包括美国4个州的20家EI机构，共包括160家EI提供商 和440个有ASD早期症状的儿童家庭，这不仅提供了一个强大的样本量， 还提供了机会，以评估这一方法在不同地区的普遍性， C部分的服务。EI提供者将被随机分配到RIT培训组（n=80）或 常规治疗（TAU; n=80）。两组中的提供者将在他们的案例中确定2-5名儿童， 16-30个月大，有ASD早期症状（每组n=220名儿童）。密集的，最先进的，多- 方法评估技术将用于衡量干预对儿童语言的影响 和社会沟通，以及父母的自我效能感和幸福感。重要的是，这项研究将研究 假定的机制（即，儿童在模仿和共同注意力方面的收益;父母的偶然反应） 通过该干预改善临床相关结果。关于提供者发起的 将分析对干预和交付的修改，以确定一致性与保真度- 不一致的变化，这将为未来RIT培训和质量保证程序的改进提供信息。在 总之，这项研究将产生必要的证据，实施RIT的规模，从而增加 现有EI系统的能力，以提供有效的，基于证据的干预，以迅速增长的 显示ASD早期迹象的儿童人群。