Testing Scalable Caregiver Interventions for Autism

NCT ID: NCT07259044

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-01
• Study Completion Date: 2030-06-01

Brief 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.

Detailed Description

Autism spectrum disorder is a common neurodevelopmental disability affecting 1-2% of children worldwide. While early intervention is critical for improving outcomes, access to quality services remains severely limited. Families in low-resource settings, both globally and within the U.S, face systemic barriers including workforce shortages, high caregiver burden, and limited culturally appropriate services. There is a critical need for scalable low-cost interventions to support children with autism and their families in communities where robust systems of care are absent.

To address this gap, researchers developed a group-based caregiver training intervention to support caregiver well-being and communication and behavior in children with autism. Piloted successfully in rural U.S. and western Kenya through the Academic Model Providing Access to Healthcare (AMPATH) Program, the intervention demonstrated feasibility, acceptability, and improvements in caregiver stress, child communication and behavior scores, and autism severity scores. Building on this foundation, researchers propose a Hybrid Type 2 effectiveness-implementation trial to rigorously evaluate both the intervention's effectiveness of improving child and caregiver outcomes and the implementation strategies needed for sustainable scale-up across health systems. The researchers embed a reciprocal innovation approach, leveraging insights from Kenya to inform U.S. communities facing similar challenges. Specifically, lessons learned from scaling peer-led delivery models in Kenya, where scare autism resources exist, will directly inform efforts to expand community-based autism support services in underserved areas of the U.S., where similar implementation challenges persist and services are variable.

The long-term goal is to reduce disparities in autism care and outcomes by developing scalable, community-driven caregiver support models. The researchers will bring together a Community Advisory Panel to ensure clinical and scientific rigor to maximize translation of findings. The overall objective of this study is to evaluate the effectiveness and implementation outcomes, including cost-effectiveness, of professional-led versus peer-led caregiver support for children with autism in Kenya, and to leverage lessons learned to reciprocally pilot-test the peer-led intervention in the U.S. To achieve this objective, the investigators propose the following Aims:

Aim 1: Evaluate the effectiveness of a group-based caregiver training program on caregiver and child outcomes in Kenya. Approach: Investigators will conduct a cluster randomized trial comparing two delivery strategies for a caregiver-focused autism intervention, either (1) structured delivery by trained professionals (e.g. therapists, teachers) using standardized scripts and materials, or (2) peer-led delivery by trained caregivers of children with autism with guided instruction; with a staggered wait-list control. Outcomes will be assessed for caregivers (quality of life (QOL), stress/burden, depressive symptoms) and children (functional communication, behavioral challenges, QOL) at enrollment, pre-/post-intervention, and 3-month follow-up. The investigators hypothesize that the caregiver training program will lead to sustained improvements in caregiver and child outcomes overall, and peer-led delivery of the intervention will be non-inferior to professional-led delivery, supporting its potential for scalability and sustainability.

Aim 2: Determine and compare key implementation outcomes, including cost-effectiveness, between two intervention delivery strategies-in-person, professional- vs. peer-led caregiver groups. Approach: Guided by the Consolidated Framework for Implementation Research (CFIR), investigators will use mixed-methods to analyze implementation outcomes of both intervention delivery strategies, including cost-effectiveness, fidelity, acceptability, feasibility, among others. A community advisor board will guide interpretation. The investigators hypothesize that while acceptability and appropriateness may be similar between the two delivery strategies, the trained peer-led delivery will demonstrate greater feasibility and lower cost, providing key insights to support piloting and scale-up in the U.S.

Aim 3: Optimize and pilot a peer-led autism caregiver intervention in the U.S., measuring key effectiveness and implementation outcomes to support scale-up in U.S. underserved settings. Approach: The investigators will use an implementation science and ecological validity framework adaptation process to revise the peer-led program for delivery in the U.S. Building on lessons from the Kenya, trained peers will deliver the adapted pilot program in Virginia. The investigators will use an explanatory sequential mixed-methods approach to evaluate effectiveness and implementation outcomes. The investigators hypothesize that the peer-led model will be feasible, acceptable, and delivered with high fidelity in U.S. under-served settings, with effectiveness, demonstrating reciprocal innovation from Kenya to the U.S. and provide key foundational insights for future scale-up.

This study's innovation lies in that it will be among the first rigorous evaluations of a scalable, caregiver-mediated autism intervention in low-resourced settings using an implementation science framework. Lessons learned from scaling peer-led delivery models in Kenya, where children receive very few services for autism, can directly inform efforts to expand community-based autism support services in underserved areas of the U.S., where similar implementation challenges persist and services are variable, for significant impact. This bidirectional learning model represents a transformative approach to developing and delivering scalable, equitable autism care throughout the U.S. and globally.

Conditions

Autism Spectrum Disorder; Autism; ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Professional-led Caregiver Groups

Group Type: EXPERIMENTAL

Professionally-facilitated groups

Intervention Type: 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 Caregiver Groups

Group Type: EXPERIMENTAL

Peer-facilitated groups

Intervention Type: 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.

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Caregiver is willing to participate
• Caregiver speaks either Swahili or English
• Child is between 2 and 8 years of age
• Child presents with concerns suggestive of autism

Exclusion Criteria

• The caregiver declines to participate
• The child has significant vision or hearing impairment
• The child is not primarily cared for by the enrolled caregiver

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moi University

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Megan Song McHenry

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eren Oyungu, MBChB

Role: PRINCIPAL_INVESTIGATOR

Moi University

Megan S. McHenry, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

University of Virginia (Virtual)

Charlottesville, Virginia, United States

Moi Teaching and Referral Hospital

Eldoret, , Kenya

Countries

United States; Kenya

Central Contacts

Ananda Ombitsa

Role: CONTACT

rananda@ampath.or.ke

+254 718 748 223

Kristen Cunningham, MPH

Role: CONTACT

kricunn@iu.edu

+1 317-278 -5675

Facility Contacts

Kristen B. Cunningham, MPH

Role: primary

Ananda Ombitsa

Role: primary

References

Achenbach TM. Child Behavior Checklist for Ages 6-18 (CBCL/6-18). ASEBA, University of Vermont. Accessed September 18, 2025, https://aseba.org/wp-content/uploads/2019/02/schoolagecbcl.pdf

Reference Type: BACKGROUND

Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Barr C, Kanne S. The Autism Impact Measure (AIM): Examination of Sensitivity to Change. Autism Res. 2020 Nov;13(11):1867-1879. doi: 10.1002/aur.2397. Epub 2020 Oct 1.

Reference Type: BACKGROUND

PMID: 33001561 (View on PubMed)

Varni JW. PedsQL™ (Pediatric Quality of Life Inventory™). James W. Varni, Ph.D. Accessed September 18, 2025, https://www.pedsql.org

Reference Type: BACKGROUND

Ferrell BRaG, Marcia. Quality of Life - Family Version. City of Hope National Medical Center and Beckman Research Institute. Accessed September 18, 2025, https://www.cityofhope.org/sites/www/files/2022-06/1431763601545-qol-family%20%282%29.pdf

Reference Type: BACKGROUND

American Psychological Association. Caregiver Self-Assessment Questionnaire. American Psychological Association. Accessed September 18, 2025, https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/self-assessment

Reference Type: BACKGROUND

Mwangi P, Nyongesa MK, Koot HM, Cuijpers P, Newton CRJC, Abubakar A. Validation of a Swahili version of the 9-item Patient Health Questionnaire (PHQ-9) among adults living with HIV compared to a community sample from Kilifi, Kenya. J Affect Disord Rep. 2020 Dec;1:100013. doi: 10.1016/j.jadr.2020.100013.

Reference Type: BACKGROUND

PMID: 33313580 (View on PubMed)

Wetherby AMaP, Barry M. CSBS™ - Communication and Symbolic Behavior Scales. Brookes Publishing Co. Accessed September 18, 2025, https://brookespublishing.com/product/csbs

Reference Type: BACKGROUND

Rutter MB, Anthony; & Lord, Catherine. Social Communication Questionnaire (SCQ®). Western Psychological Services (WPS). Accessed September 18, 2025, https://www.wpspublish.com/scq-social-communication-questionnaire.html

Reference Type: BACKGROUND

Other Identifiers

96463446

Identifier Type: -

Identifier Source: org_study_id