Caregiver Interventions for Autism

Not yet recruiting at 1 trial location

Overseen By Kristen Cunningham, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Megan S. McHenry, MD, MS

Principal Investigator

Indiana University

Eren Oyungu, MBChB

Principal Investigator

Moi University

Are You a Good Fit for This Trial?

This trial is for caregivers of children with Autism Spectrum Disorder. It aims to help those facing challenges like limited access to care, high stress, and a lack of culturally appropriate services. Caregivers must be willing to participate in group training programs.

Inclusion Criteria

My child shows signs that may suggest autism.

My child is between 2 and 8 years old.

My caregiver speaks Swahili or English.

Exclusion Criteria

The child is not primarily cared for by the enrolled caregiver

My child has major problems with their sight or hearing.

My caregiver has chosen not to participate.

What Are the Treatments Tested in This Trial?

Interventions

• Scalable Caregiver Interventions for Autism

Trial Overview The study tests two types of caregiver training programs: one led by professionals and another by peers who are also caregivers. The goal is to see which model better improves caregiver well-being and child communication and behavior.

How Is the Trial Designed?

Group I: Professional-led Caregiver Groups Experimental Treatment 1 Intervention

Group II: Peer-facilitated Caregiver Groups Experimental Treatment 1 Intervention

Group III: Waitlist control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Moi University

Collaborator

Trials

40

Recruited

92,600+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+