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: 10646239
• 负责人: Alice S. Carter
• 金额: $ 93.35万
• 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/10646239
• 关键词: Address; Aftercare; Age; Area; Behavior; Behavior Therapy; Birth; Characteristics; Child; Child Language; Child Rearing; Code; Consensus; Consensus Development; Consultations; Data; Development; Developmental Delay Disorders; Developmental Disabilities; Disabled Persons; Early Intervention; Education; Educational process of instructing; Effectiveness; Equity; 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, Controlled Trials; Reporting; Research; Role; Sample Size; Sampling; Self Efficacy; Services; Site; Source; Stress; Symptoms; System; Technology Assessment; Testing; Training; Variant; acceptability and feasibility; autism spectrum disorder; autistic children; clinically relevant; data management; dosage; economic cost; effectiveness evaluation; effectiveness testing; effectiveness/implementation design; effectiveness/implementation hybrid; 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; randomized, clinical trials; 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，专门的干预达成了强烈共识 （ASD）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 ASD患病率的迅速上升受到严重挑战。长期目标是改善 通过增加提供适当专业治疗的能力，具有ASD早期迹象的儿童 在现有的基础架构中：C部分早期干预（EI）服务交付系统。 C部分是公开的 资助，在所有地区可用，并为3岁以下的患有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实践差异的限制，并且很少使用证据 - 基于干预措施。研究目标是改善具有早期迹象的儿童的服务和结果 通过进行随机对照试验（RCT）测试培训EI提供者的有效性，ASD 提供相互模仿训练（RIT）。 RIT是一种自然的发展行为干预（NDBI） 理想情况下适合EI设置，因为它是低强度，基于游戏的，易于学习和实现的，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 收集证据的方法方法，这对于大规模实施RIT至关重要，等待积极试验 结果。该样本包括美国4个州的20个EI机构，共有160个EI提供商 和440个患有ASD早期症状的儿童家庭，不仅提供了强大的样本量，而且提供 还提供了评估这种方法在各个地区的普遍性的机会 C部分服务的实施。 EI提供者将随机分配给RIT培训组（n = 80）或 照常治疗（tau; n = 80）。两组的提供者都会在其案件中识别2-5名儿童 16-30个月大的ASD早期症状（每组n = 220名儿童）。密集，最先进，多 方法评估技术将用于衡量干预对儿童语言的影响 和社会交流，以及父母的自我效能和福祉。重要的是，这项研究将检查 推定的机制（即模仿和共同注意的儿童收益；父母的反应能力） 干预可以改善与临床相关的结果。有关提供商发起的数据 将分析对干预和交付的修改，以确定富达一致性与忠诚度 - 不一致的变化将为未来的RIT培训和质量保证程序的完善提供信息。在 总而言之，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EI系统的能力提供有效的，基于证据的干预措施 表现出ASD早期迹象的儿童人口。