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Clinical Trial Summary

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. States. This project will train EI providers to use an evidence-based, inexpensive, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Clinical Trial Description

The long-term goal of this study is to improve services and 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 throughout the United States, 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. We are conducting a randomized controlled trial (RCT) to examine the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT) to children showing early signs of ASD. 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, multimethod 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. Child and family assessments will be conducted at baseline, 3 months after enrollment, and 9 months after enrollment. Importantly, this study will examine putative mechanisms through which RIT improves clinically-relevant outcomes (i.e., child gains in imitation and joint attention; parent contingent responsiveness). 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. a. Hypotheses 1. Compared to TAU, children assigned to the RIT group will show more growth from baseline (T1) to the 9-month follow-up (T3) in motor imitation, initiating joint attention, language, and social communication. 2. The impact of RIT on children's social communication and language outcomes at T3 will be mediated by gains in: (a) child joint attention; (b) child motor imitation; and (c) parent contingent responsivity, as measured from baseline to the 3 month follow-up (T2). 3. Compared to TAU, caregivers assigned to the RIT group will show more improvement in contingent responsivity, parenting efficacy, and family quality of life from baseline to the 9-month follow-up. 4. The impact of RIT on growth of children's social communication and language outcomes from baseline to the 9-month follow-up will be mediated by: (a) providers' fidelity of use of RIT strategies following training; and (b) caregivers' frequency and fidelity of use of RIT strategies after treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05114538
Study type Interventional
Source University of Washington
Contact Lisa V Ibanez, PhD
Phone 206 616-7358
Email [email protected]
Status Recruiting
Phase N/A
Start date September 27, 2021
Completion date March 2023

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