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

NCT07259044 | Not Yet Recruiting

• 1 other identifier: 96463446
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

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, post-intervention, and 3-month follow-up

• Child Functional Communication

  Change in child functional communication measured using the Communication and Symbolic Behavior Scales (CSBS). Higher scores indicate stronger communication skills and improved functional communication abilities.

  Baseline, immediately post-intervention, and 3-month follow-up

Secondary Outcomes (10)

• Quality of Life in Caregivers

  Baseline, post-intervention, and 3-month follow-up

• Quality of Life in Children

  Baseline, post-intervention, and 3-month follow-up

• Parenting Stress Index

  Baseline, post-intervention, and 3-month follow-up

• Depressive Symptoms in Caregivers

  Baseline, post-intervention, and 3-month follow-up

• Child Behavior Checklist (CBCL)

  Baseline, post-intervention, and 3-month follow-up

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 Pepea Pamoja

EXPERIMENTAL

Participants will receive the standardized ten-session Pepea Pamoja caregiver intervention delivered by trained professional facilitators, including professionals with backgrounds such as occupational therapy, psychology, speech-language therapy, special education, or related disciplines. The curriculum includes autism education, caregiver coping and self-care, communication and behavior-support strategies, visual supports, positive reinforcement, requesting skills, guided problem solving, caregiver-child practice activities, and group-based peer support.

Behavioral: Professionally-facilitated groups

Peer-led Pepea Pamoja

EXPERIMENTAL

Participants will receive the same ten-session Pepea Pamoja curriculum, dose, caregiver practice opportunities, participant materials, and fidelity standards delivered by trained and competency-certified caregivers with lived experience caring for a child with autism. Peer facilitators will receive structured supervision, fidelity monitoring, booster training, and remediation when indicated

Behavioral: Peer-facilitated groups

Standard of Care Control

NO INTERVENTION

Participants will receive information about locally available services, including occupational therapy at MTRH, private speech-language therapy options, and relevant schools and community resources. Participants may receive any otherwise available non-study care, which will be documented. They will also be invited to a moderated caregiver group chat that supports social connection but does not provide Pepea Pamoja curriculum content, caregiver skills instruction, or intervention coaching.

Interventions

Professionally-facilitated groups BEHAVIORAL

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.

Professional-led Pepea Pamoja

Peer-facilitated groups BEHAVIORAL

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.

Peer-led Pepea Pamoja

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Moi University: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

Related Publications (10)

• McLay L, Emerson LM, Waddington H, van Deurs J, Hunter J, Blampied N, Hapuku A, Macfarlane S, Bowden N, van Noorden L, Rispoli M. Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial. BMJ Open. 2023 May 30;13(5):e071235. doi: 10.1136/bmjopen-2022-071235.

  PMID: 37253492 BACKGROUND

• McNally Keehn R, Rispoli M, Saina C, Nafiseh A, Oyungu E, Omari FW, Kigen B, Hassinger T, Stewart L, Gross J, McHenry M. Pepea Pamoja:dagger Applying the Ecological Validity Framework to co-develop a wellbeing and behavioural training program for caregivers of young children with autism in low-resource settings of Kenya and the United States. Child Care Health Dev. 2024 Jul;50(4):e13299. doi: 10.1111/cch.13299.

  PMID: 38967420 BACKGROUND

• 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, MS

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: Participants and facilitators cannot be masked because of the nature of the behavioral intervention. Independent outcome assessors will remain masked to assigned study arm whenever feasible. Coders of standardized caregiver-child interaction recordings will be masked to study arm and assessment time point.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Caregiver groups (clusters) will be randomized in a 1:1:1 ratio to standard-of-care control, professional-led Pepea Pamoja, or peer-led Pepea Pamoja. Consecutively formed caregiver groups will be randomized at prespecified allocation waves, with equal numbers of groups assigned to each study arm during each wave. Randomization occurs at the caregiver-group level to minimize contamination and reflect the group-based nature of intervention delivery.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

KE (1)