Clinical Trial

Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention

Recruiting
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Summary
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-15
notable Primary completion pushed: 2027-07 -> 2027-08-31 2026-07-15
minor Completion pushed: 2027-09 -> 2027-10-31 2026-07-15
Trial Details
NCT Number NCT07471594
Lead Sponsor University of South Carolina
Collaborators: National Institute of Mental Health (NIMH)
Conditions Autism
Enrollment 40 participants
Start Date 2026-03-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14