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NCT05114538Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
440 (estimated)
First submitted
6 Oct 2021
Start date
27 Sept 2021
Primary completion date
31 May 2026
Lead sponsor
Rush University Medical Center
Diseases
Autism
NCT number
NCT05114538

What you commit to

  • Study type: Interventional
  • Planned participants: 440
  • From 27 Sept 2021 to the primary completion date, 31 May 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • \- the child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments

Who the study is looking for

  • Child has a diagnosis of ASD or displays early social communication challenges
  • Child receives ≥ 1 weekly session with the participating provider (not co-treated with another provider)
  • Caregiver is present during EI sessions
  • Caregiver is the biological parent or custodial guardian
  • Caregiver is at least 18 years of age
  • Caregiver speaks either English or Spanish

Age in the registry: 16 months to 33 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Massachusetts-Boston
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Michigan State University
Coordinator of this site? Confirm its status
East LansingUnited StatesUnknown status
Carol A Schubert
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.