NCT07259044Not yet recruiting
Pepea Pamoja: Cluster-Randomized Trial for Caregivers of Children With Autism in Kenya
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 24 Sept 2025
- Start date
- 1 Jul 2027
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Indiana University
- Diseases
- Autism
- NCT number
- NCT07259044
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Jul 2027 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child is currently receiving another structured autism intervention at enrollment.
Other illness
- Child has a vision or hearing impairment that would preclude valid participation in the intervention or outcome assessments.
Other
- Caregiver lacks capacity to provide informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moi Teaching and Referral Hospital Coordinator of this site? Confirm its status | Eldoret | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.