Testing Scalable Caregiver Interventions for Autism

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Indiana University
Study ID
NCT07259044
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Professionally-facilitated groups — BEHAVIORAL
    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.
  • Peer-facilitated groups — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Professional-led Caregiver Groups
  • Experimental: Peer-facilitated Caregiver Groups
  • No Intervention: Waitlist control

Primary Outcome Measure

Family Burden and Stress [ Time Frame: Baseline and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia (Virtual)CharlottesvilleVirginia22903
Kristen B. Cunningham, MPH

Find similar trials in Charlottesville, VA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Virginia (Virtual)· Charlottesville, VA

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