Testing Scalable Caregiver Interventions for Autism
NCT07259044 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2025-12-02
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.
Conditions
Interventions
- BEHAVIORAL
-
Professionally-facilitated groups
A group-based caregiver ASD intervention will be delivered through two distinct implementation strategies led by trained therapists or teachers using a structured 10-week in-person curriculum at the MTRH campus and virtually in the US.
- BEHAVIORAL
-
Peer-facilitated groups
A group-based caregiver ASD intervention will be delivered through two distinct implementation strategies led by trained caregivers of children with ASD who deliver the same core curriculum with flexibility in timing and location, provided that all content is completed within four months.
Sponsors & Collaborators
-
Moi University
collaborator OTHER -
University of Virginia
collaborator OTHER -
Indiana University
lead OTHER
Principal Investigators
-
Eren Oyungu, MBChB · Moi University
-
Megan S. McHenry, MD, MS · Indiana University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2029-06-30
- Completion
- 2030-06-01
Countries
- United States
- Kenya
Study Locations
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