Testing Scalable Caregiver Interventions for Autism

NCT07259044 | Not Yet Recruiting

• 1 other identifier: 96463446
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 2

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.

Conditions

Autism Spectrum Disorder; Autism; ASD

Keywords

Caregiver Intervention; Training; Children; Low Resource; Disability; Early Intervention

Outcome Measures

Primary Outcomes (2)

• Family Burden and Stress

  Change in caregiver-reported burden and stress levels from baseline to 3 months, measured using the Caregiver Self-Assessment Questionnaire developed by the American Medical Association. This 18-item tool includes 16 yes/no items assessing emotional and physical strain, one item rating stress on a scale from 1 (no stress) to 10 (high stress), and one item comparing current health to health one year ago. Higher scores indicate greater caregiver burden and stress.

  Baseline and 3 months

• Autism Impact Measure (AIM)

  Change in caregiver-reported communication and symbolic behavior from baseline to 3 months, measured using the Autism Impact Measure (AIM), which integrates domains from the Communication and Symbolic Behavior Scale (CSBS). The AIM is a validated caregiver-report tool assessing autism-related behaviors across five domains, including communication and social reciprocity. The CSBS is a norm-referenced, standardized instrument that evaluates early communication development through 22 rating scales grouped into seven clusters: communicative functions, gestural and vocal means, verbal means, reciprocity, social-affective signaling, and symbolic behavior. Higher AIM scores indicate greater autism-related impact.

  Baseline and 3 months

Secondary Outcomes (7)

• Quality of Life in Caregivers

  Baseline and 3 months

• Quality of Life in Children

  Baseline and 3 months

• Parenting Stress Index

  Baseline and 3 months

• Depressive Symptoms in Caregivers

  Baseline and 3 months

• Child Behavior Checklist (CBCL)

  Baseline and 3 months

Other Outcomes (8)

• Acceptability of Intervention

  Post-intervention (6 months)

• Feasibility of Intervention - Quantitative Assessment

  Post-intervention (6 months)

• Feasibility of Intervention - Qualitative Assessment

  Post-intervention (6 months)

Study Arms (3)

Professional-led Caregiver Groups

EXPERIMENTAL

Behavioral: Professionally-facilitated groups

Peer-facilitated Caregiver Groups

EXPERIMENTAL

Behavioral: Peer-facilitated groups

Waitlist control

NO INTERVENTION

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.

Professional-led Caregiver Groups

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.

Peer-facilitated Caregiver Groups

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Moi University: collaborator
• University of Virginia: collaborator

Study Sites (2)

University of Virginia (Virtual)

Charlottesville, Virginia, 22903, United States

Location

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

Related Publications (8)

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

  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

  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

  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.

  PMID: 33313580 BACKGROUND

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

  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

  BACKGROUND

• 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

  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.

  PMID: 33001561 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Eren Oyungu, MBChB

  Moi University

  PRINCIPAL INVESTIGATOR

• Megan S. McHenry, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ananda Ombitsa

CONTACT

+254 718 748 223; rananda@ampath.or.ke

Kristen Cunningham, MPH

CONTACT

+1 317-278 -5675; kricunn@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will be masked to group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: At each site, groups will be randomly assigned to be led by either trained professionals (e.g., occupational therapists or special education teachers) or peer facilitators (caregivers of children with autism trained in the curriculum).

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

KE (1); US (1)