NCT05114538

Improving the Part C Early Intervention Service Delivery System for Children With ASD

Active, enrolled NA Last updated 17 April 2026

What this trial tests

NA trial testing Reciprocal Imitation Training in Autism Spectrum Disorder in 440 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 September 2021

Primary endpoint
31 May 2026

31 May 2026

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	440
Start date	27 September 2021
Primary completion	31 May 2026
Estimated completion	31 May 2026
Sites	4 locations across United States

Drugs / interventions tested

• Reciprocal Imitation Training

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

University of Washington

Who can join

Adults 16 Months to 33 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applying a User-Centered Design Framework to Develop a Remote Research Assessment Protocol for a Randomized Clinical Trial for Toddlers with Early Autism Characteristics.
   Tagavi DM, Dai YG, Berger NI, Petruccelli M, et al · · 2025 · cited 4× · PMID 38985370 · DOI 10.1007/s10803-024-06455-7
2. The Language ENvironment Analysis (LENA) System in Toddlers With Early Indicators of Autism: Test-Retest Reliability and Convergent Validity With Clinical Language Assessments.
   Nadwodny N, Yoder PJ, Ingersoll BR, Wainer AL, et al · · 2025 · cited 3× · PMID 40452405 · DOI 10.1002/aur.70062
3. Employing user-centered design to develop a remote technology kit for studying young children's social communication skills.
   Petruccelli M, Howard M, Morelos A, Wainer A, et al · · 2025 · cited 3× · PMID 39118192 · DOI 10.1093/jpepsy/jsae065
4. A hybrid type I randomized effectiveness-implementation trial of a Naturalistic Developmental Behavioral Intervention in the Part C early intervention system: study protocol.
   Wainer AL, Edmunds SR, Carter AS, Stone WL, et al · · 2025 · cited 1× · PMID 40170032 · DOI 10.1186/s12887-025-05587-8
5. Adapting measures of motor imitation for use by caregivers in virtual contexts: Reliability, validity, and sensitivity to change.
   Ingersoll B, Howard M, Oosting D, Carter AS, et al · · 2025 · cited 1× · PMID 39569704 · DOI 10.1002/aur.3267
6. Using virtual multiteam systems to conduct a multisite randomized clinical trial in the part C early intervention system: Benefits, challenges, and lessons learned.
   Ingersoll B, Espinel A, Nauman J, Broder-Fingert S, et al · · 2024 · cited 1× · PMID 38821261 · DOI 10.1016/j.cct.2024.107585
7. Validating the RISE Communication Play Protocol as a Diagnostic Tool for Autism in Early Childhood: A Pilot Study.
   Dai YG, Tagavi DM, Stone WL, Carter AS. · · 2026 · PMID 39843660 · DOI 10.1007/s10803-025-06719-w