Improving early intervention services for children with autism
Improving the Part C Early Intervention Service Delivery System for Children with ASD: a Randomized Clinical Trial
This study is testing a new way to help young children with autism by training their caregivers to use a special teaching method to improve communication skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 16 Months to 33 Months |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT05114538 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance access to specialized early intervention services for children with Autism Spectrum Disorder (ASD) by utilizing the existing Part C Early Intervention system. The study will train early intervention providers to implement an evidence-based, parent-mediated intervention called Caregiver-Implemented Reciprocal Imitation Teaching (CI-RIT). By focusing on children with early social communication challenges, the research seeks to improve child and family outcomes while addressing the economic costs associated with ASD. A randomized controlled trial will be conducted across multiple states to evaluate the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with ASD or those showing early social communication challenges, along with their caregivers who can participate in the intervention.
Not a fit: Patients with visual, hearing, or motor conditions that hinder their ability to participate in the intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly improve developmental outcomes for children with ASD and their families.
How similar studies have performed: Other studies have shown success with similar parent-mediated interventions, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria - the child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments
Where this trial is running
Chicago, Illinois and 3 other locations
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Massachusetts Boston — Boston, Massachusetts, United States (Recruiting)
- Michigan State University — East Lansing, Michigan, United States (Recruiting)
- Carol A Schubert — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Wendy L Stone, PhD — University of Washington
- Study coordinator: Carol A Schubert, MPH
- Email: schubca@uw.edu
- Phone: 206-543-2823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.