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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07259044). StuddyBuddy aggregates publicly available trial information.