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NCT07259044
Pepea Pamoja: Cluster-Randomized Trial for Caregivers of Children With Autism in Kenya
Conditions: Autism Spectrum Disorder, Autism, ASD
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: Indiana University
Location: Moi Teaching and Referral Hospital Eldoret
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.
Eligibility Criteria
Inclusion Criteria:
* Caregiver age ≥18 years
* Able to provide informed consent
* English or Kiswahili speaking
* Primary caregiver and legal guardian
* Provides ≥20 hours/week caregiving
* Resides within MTRH catchment area
* Intends to attend study activities
* Child 2-8 years of age
* Child has autism diagnosis or meets study eligibility criteria for suspected autism
Exclusion Criteria:
* Caregiver lacks capacity to provide informed consent.
* Child has a vision or hearing impairment that would preclude valid participation in the intervention or outcome assessments.
* Child is currently receiving another structured autism intervention at enrollment.
Source: ClinicalTrials.gov (NCT07259044). StuddyBuddy aggregates publicly available trial information.