Improving the Part C Early Intervention Service Delivery System for Children With ASD (NCT05114538) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Improving the Part C Early Intervention Service Delivery System for Children With ASD
United States440 participantsStarted 2021-09-27
Plain-language 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 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.
Who can participate
Age range
16 Months – 33 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on improving how early intervention services are delivered under Part C — which is the federal program for children under 3 — so would my child's current age and service enrollment status make them a good fit to discuss with the care team?
2The trial is measuring something called 'unstructured imitation' as its main outcome — can you explain what that means in practical terms and why improving imitation skills might matter for my child's development with ASD?
3Since this study is listed as 'active not recruiting,' does that mean enrollment is already closed, and if so, are there similar early intervention studies or programs we could still explore for my child?
4This trial appears to be targeting the service delivery system itself, not a medication or device — so how does that differ from other types of interventions my child might receive, and could participating affect the standard early intervention services they're already getting?
5Given that this is listed as Phase NA, which often applies to behavioral or systems-level research rather than drug trials, what does that mean for what's already known about the safety and effectiveness of this kind of approach for young children with ASD?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.