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: 10405466
• 负责人: Alice S. Carter
• 金额: $ 95.83万
• 依托单位: UNIVERSITY OF MASSACHUSETTS BOSTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10405466
• 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; 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 delivery; 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.

项目概要 尽管人们一致认为对自闭症谱系障碍儿童进行早期、专门的干预 （自闭症谱系障碍）可能会对结果产生巨大影响，美国卫生系统提供此类服务的能力是 自闭症谱系障碍 (ASD) 患病率迅速上升所带来的严峻挑战。长期目标是改善结果 通过提高提供适当专业治疗的能力，患有自闭症谱系障碍早期症状的儿童 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 该项目由资金资助，适用于所有领域，为 3 岁以下发育迟缓或残疾的儿童提供服务。 目前，EI 服务的有效性受到高度实践差异和证据使用不频繁的限制。 为基础的干预措施。该研究的目的是改善对有早期症状的儿童的服务和结果 ASD 通过开展随机对照试验 (RCT) 来测试培训 EI 提供者的有效性 提供相互模仿训练（RIT）。 RIT是一种自然主义发展行为干预（NDBI） 非常适合 EI 设置，因为它强度低、基于游戏、易于学习和实施，并且 可以教给家庭独立使用，从而增加干预剂量。 该 RCT 将采用混合 1 型有效性/实施设计，并将使用独特的混合 方法收集对于大规模实施 RIT 至关重要的证据，等待积极试验 结果。样本包括美国 4 个州的 20 家 EI 机构，总共 160 家 EI 提供商 以及 440 个有 ASD 早期症状的儿童家庭，这不仅提供了可靠的样本量，而且 还提供了评估这种方法在不同地区的普遍适用性的机会 C 部分服务的实施。 EI 提供者将被随机分配到 RIT 培训组 (n=80) 或 照常治疗（TAU；n=80）。两组的提供者都会在他们的案例中识别出 2-5 名儿童，他们是 16-30 个月大且有 ASD 早期症状的儿童（每组 220 名儿童）。集约化、尖端化、多元化 方法 评估技术将用于衡量干预措施对儿童语言的影响 和社交沟通，以及父母的自我效能和幸福感。重要的是，这项研究将检验 假定的机制（即孩子在模仿和共同注意力方面的进步；父母的偶然反应） 通过这种干预措施可以改善临床相关的结果。有关提供商发起的数据 将分析对干预和交付的修改，以确定保真度一致与保真度一致 不一致的变化，这将为未来 RIT 培训和质量保证程序的完善提供信息。在 总之，这项研究将产生大规模实施 RIT 所需的证据，从而提高 现有 EI 系统为快速增长的经济体提供有效、基于证据的干预的能力 表现出自闭症谱系障碍早期症状的儿童群体。