Wainer Allison L, Edmunds Sarah R, Carter Alice S, Stone Wendy L, Sheldrick R Christopher, Broder-Fingert Sarabeth, Stern Yael S, Harrington Ellie, V Ibanez Lisa, Ingersoll Brooke
Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 603, Chicago, IL, 60612, USA.
Department of Psychology, University of South Carolina, Barnwell College, 1512 Pendleton St, Columbia, SC, 29208, USA.
BMC Pediatr. 2025 Apr 1;25(1):263. doi: 10.1186/s12887-025-05587-8.
Participation in Naturalistic Developmental Behavioral Interventions (NDBI) is associated with significant improvements in functioning for toddlers with, and showing early signs of, autism spectrum disorder. The Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. states, offers an optimal infrastructure through which toddlers can receive NDBIs. This study seeks to assess the effectiveness and fit of one NDBI, Caregiver Implemented Reciprocal Imitation Teaching (CI-RIT), within the Part C EI system.
This hybrid type 1 effectiveness/implementation trial uses a multi-site randomized control design to simultaneously test effectiveness and collect implementation data on CI-RIT in the Part C EI system across four states: Illinois, Massachusetts, Michigan and Washington. Participants include EI providers (target n = 160) who are randomized to either CI-RIT or treatment as usual (TAU), and child/caregiver dyads on their caseloads (target n = 440). Primary effectiveness outcomes focus on (1) child social communication, joint attention, motor imitation; and (2) caregiver responsivity, implementation fidelity of RIT, and self-efficacy, which are all measured at baseline and then 4-months and 9-months after baseline. Implementation outcomes include CI-RIT modifications, treatment acceptability, fidelity of CI-RIT coaching, and RIT session completion.
This study represents a critical effort to transport an evidence-based NDBI, CI-RIT, into a national service delivery setting, the Part C EI system. The large, multi-site nature of the trial provides the opportunity to address critical questions about training and intervention effectiveness, which will, in turn, optimize and support CI-RIT implementation at scale.
The trial protocol is registered at ClinicalTrials.gov (NCT05114538; Registration date: 10/28/2021).
参与自然主义发展行为干预（NDBI）与自闭症谱系障碍患儿及其早期迹象患儿的功能显著改善相关。C部分早期干预（EI）系统由公共资金支持，在美国所有州均可使用，为幼儿接受NDBI提供了最佳基础设施。本研究旨在评估一种NDBI，即照顾者实施的相互模仿教学（CI-RIT），在C部分EI系统中的有效性和适应性。
这项1型混合有效性/实施试验采用多中心随机对照设计，同时测试有效性，并在伊利诺伊州、马萨诸塞州、密歇根州和华盛顿州四个州的C部分EI系统中收集关于CI-RIT的实施数据。参与者包括EI提供者（目标n = 160），他们被随机分配到CI-RIT组或常规治疗（TAU）组，以及他们所负责的儿童/照顾者二元组（目标n = 440）。主要有效性结果集中在：（1）儿童社交沟通、共同注意、动作模仿；（2）照顾者反应性、RIT实施保真度和自我效能感，这些均在基线时测量，然后在基线后4个月和9个月测量。实施结果包括CI-RIT的修改、治疗可接受性、CI-RIT指导的保真度以及RIT课程完成情况。
本研究是将基于证据的NDBI，即CI-RIT，引入国家服务提供环境，即C部分EI系统的一项关键努力。该试验的大规模、多中心性质为解决有关培训和干预有效性的关键问题提供了机会，这反过来将优化并支持CI-RIT的大规模实施。
试验方案已在ClinicalTrials.gov注册（NCT05114538；注册日期：2021年10月28日）。
