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

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.

Grant Number: 5R01MH122728-05
NIH Institute/Center: NIH
Principal Investigator: Alice Carter