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NOT YET RECRUITING
NCT07259044
NA

Pepea Pamoja: Cluster-Randomized Trial for Caregivers of Children With Autism in Kenya

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

Pepea Pamoja is a ten-session, group-based caregiver intervention designed to improve caregiver well-being and strengthen caregivers' ability to support communication and positive behavior in children with autism. This study will enroll approximately 240 caregivers of children ages 2-8 years in western Kenya. Caregiver groups will be randomized to one of three conditions: standard-of-care control, professional-led Pepea Pamoja, or peer-led Pepea Pamoja. The study will determine whether each Pepea Pamoja delivery model improves caregiver and child outcomes compared with control and will directly compare peer-led and professional-led delivery. Outcomes will include caregiver stress and well-being, child communication and behavior, and blinded observations of child social communication and caregiver-child interaction. An embedded mixed-methods evaluation will examine implementation, sustainability, program and societal costs, and cost-effectiveness.

Official title: A Three-Arm Cluster-Randomized Comparative Effectiveness Trial of Professional-Led and Peer-Led Pepea Pamoja for Caregivers of Children With Autism in Western Kenya

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2027-07-01

Completion Date

2030-06-01

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

BEHAVIORAL

Professionally-facilitated groups

Participants will receive the standardized ten-session Pepea Pamoja caregiver intervention delivered by trained professional facilitators. Core curriculum content, session structure, caregiver practice opportunities, participant materials, and fidelity standards will be standardized across active intervention arms.

BEHAVIORAL

Peer-facilitated groups

Participants will receive the same Pepea Pamoja curriculum and intervention dose as the professional-led arm. Delivery will be provided by trained caregivers with lived experience raising a child with autism who have successfully completed facilitator training and competency assessment.

Locations (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya