NCT07471594Recruiting
Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- University of South Carolina
- Diseases
- Autism
- NCT number
- NCT07471594
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Mar 2026 to the primary completion date, 31 Aug 2027
- 1 site 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.
Prior treatment
- Is not receiving services in BabyNet at least one half-hour per week
Age
- Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)
- Not between 18 and 75 years of age
- Is not between 12 and 36 months of age
Other
- Not contracted or employed by BabyNet
- Provides services less than one half-hour per week
- Not the legal guardian of the child
- Not able to be present for BabyNet services
- Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Who the study is looking for
- Able to provide written and informed consent;
- Both sexes and all racial and ethnic origins;
- English fluency (necessary for informed consent and measure completion)
- Is between 18 and 75 years of age
- Holds a contract with or formally employed by BabyNet
- Provides services within BabyNet at least one half-hour per week
- Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
- Is between 18 and 75 years of age
- Is the legal guardian of the participating child
- Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services
- Is between 12 and 36 months of age
- Is enrolled in BabyNet services at least one half-hour per week
- Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Criteria the registry did not label
- The following is a list of inclusion and exclusion criteria by participant group across all three research aims.
Age in the registry: 12 months to 36 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.