Clinical Trial

Testing Scalable Caregiver Interventions for Autism

Not Yet Recruiting
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Summary
Autism spectrum disorder affects 1-2% of children worldwide, yet access to quality care remains limited, especially in underserved communities. Families face systemic barriers such as workforce shortages, high caregiver stress, and a lack of culturally appropriate services. To address these gaps, researchers developed a group-based caregiver training program to improve caregiver well-being and child communication and behavior. Successfully piloted in rural U.S. communities and western Kenya through the AMPATH Program, the intervention showed promising results in reducing caregiver stress and autism severity. Building on this success, a new study will evaluate two delivery models-professionally-led and peer-led-using a rigorous effectiveness-implementation trial. The project applies a reciprocal innovation approach, using insights from Kenya to inform U.S. strategies for scaling community-based autism support. The long-term goal is to reduce disparities in autism care by creating scalable, low-cost, caregiver-driven models. A Community Advisory Panel will guide the research to ensure relevance and impact. This initiative represents a transformative step toward equitable autism services across global and U.S. settings.
Trial Details
NCT Number NCT07259044
Lead Sponsor Indiana University
Collaborators: Moi University, University of Virginia
Conditions Autism Spectrum Disorder, Autism, ASD
Enrollment 320 participants
Start Date 2026-07-01
Primary Completion 2029-06-30 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-02