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

August 27, 2026 updated by: Megan Song McHenry, Indiana University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Autism spectrum disorder is a common neurodevelopmental condition associated with challenges in communication, social interaction, behavior, adaptive functioning, and family well-being. Access to autism-specific intervention remains limited in many low-resource settings, including Kenya, where shortages of trained specialists and services create substantial barriers to care. Caregiver-mediated interventions offer an important opportunity to improve outcomes by strengthening caregivers' ability to support their children's communication, behavior, and development during everyday routines while also addressing caregiver well-being.

Pepea Pamoja ("to lift or float together" in Kiswahili) is a culturally responsive, group-based caregiver intervention developed to improve caregiver well-being and increase caregivers' skills in supporting communication and positive behavior among children with autism. The ten-session program integrates autism education, caregiver coping and self-care, communication and behavior-support strategies, visual supports, positive reinforcement, guided problem solving, caregiver-child practice activities, and peer support. The intervention is designed to strengthen caregiver knowledge, self-efficacy, coping skills, and use of evidence-informed communication and behavior-support strategies during daily interactions with their children. These changes are hypothesized to improve caregiver-child interactions, child communication and behavior, caregiver stress, and family quality of life.

This study is a three-arm cluster-randomized comparative effectiveness trial conducted in western Kenya. Approximately 240 caregiver-child dyads will be enrolled in 48 caregiver groups (clusters) and randomized in a 1:1:1 ratio to one of three study conditions: (1) standard-of-care control, (2) professional-led Pepea Pamoja, or (3) peer-led Pepea Pamoja. Randomization will occur at the caregiver group level to minimize contamination and reflect the group-based nature of intervention delivery. Consecutively formed caregiver clusters will be randomized at prespecified allocation waves, with equal numbers of clusters assigned to each study arm during each wave of enrollment.

The first aim is to determine the effectiveness of professional-led and peer-led Pepea Pamoja compared with standard-of-care control on caregiver and child outcomes. Outcomes include caregiver burden and well-being, child communication, child behavior, child quality of life, and caregiver-child interaction. Assessments will be conducted at baseline, immediately following intervention completion, and approximately three months after intervention completion.

The second aim is to compare peer-led and professional-led delivery models and evaluate potential mechanisms through which facilitator type may influence outcomes. These mechanisms include caregiver knowledge, self-efficacy, caregiver strategy use, and caregiver-child interaction. The study will evaluate whether differences in facilitator type are associated with differences in caregiver or child outcomes and will estimate comparative effectiveness between the two active intervention models.

The third aim is to compare implementation, sustainability, and economic outcomes associated with professional-led and peer-led delivery of Pepea Pamoja. The study will assess implementation outcomes including acceptability, appropriateness, feasibility, fidelity, reach, adaptations, facilitator competency, facilitator burden, facilitator retention, and supervision requirements. Sustainability outcomes will evaluate the resources, organizational supports, and workforce requirements needed to maintain intervention delivery beyond the study period. Economic analyses will compare program costs, societal costs, and cost-effectiveness across study arms.

The results of this study will provide evidence regarding the effectiveness of Pepea Pamoja, the comparative effectiveness of professional-led and peer-led delivery models, and the implementation, sustainability, and economic requirements needed to support adoption and scale-up of caregiver-mediated autism interventions in resource-constrained settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Kristen Cunningham, MPH, MS
  • Phone Number: +1 317-278 -5675
  • Email: kricunn@iu.edu

Study Locations

  • Kenya
      • Eldoret, Kenya
        • Moi Teaching and Referral Hospital
        • Contact:
          • Ananda Ombitsa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Professional-led Pepea Pamoja
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
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.
Experimental: Peer-led Pepea Pamoja
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
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.
No Intervention: Standard of Care Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family Burden and Stress
Time Frame: Baseline, post-intervention, and 3-month follow-up
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
Time Frame: Baseline, immediately post-intervention, and 3-month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: 3 months
Effectiveness and cost will be analyzed jointly using multilevel models with random effects for site and group, and incremental cost-effectiveness ratios (ICERs) will be computed. Net Monetary Benefit (NMB) mixed-effect regressions will allow formal testing of heterogeneity (e.g., baseline severity of autism, living condition, caregiver education and other socioeconomic factors). Uncertainty will be assessed using clustered bootstraps and cost-effectiveness acceptability curves (CEACs).
3 months
Quality of Life in Caregivers
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in caregiver-reported quality of life from baseline to 3 month follow-up, measured using the Quality of Life - Family Version instrument developed by Betty Ferrell, PhD. This 37-item ordinal scale assesses quality of life across four domains for family members caring for a patient. Each item is rated from 0 (worst outcome) to 10 (best outcome), with several items reverse-scored. Subscale scores are calculated by averaging items within each domain. Higher overall scores indicate better caregiver quality of life.
Baseline, post-intervention, and 3-month follow-up
Quality of Life in Children
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in caregiver-reported quality of life for children from baseline to 3 month follow-up, measured using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales. This 23-item instrument assesses physical, emotional, social, and school functioning across four multidimensional scales and three summary scores. It is developmentally appropriate for ages 2-18 and includes both child self-report (ages 5-18) and parent proxy-report (ages 2-18). Scores range from 0 to 100, with higher scores indicating better quality of life.
Baseline, post-intervention, and 3-month follow-up
Parenting Stress Index
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in parenting stress from baseline to 3 month follow-up, measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF total score ranges from 36 to 180, with higher scores indicating greater parenting stress and a worse outcome. Each of the 36 items is rated on a 5-point Likert scale, and the measure includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Baseline, post-intervention, and 3-month follow-up
Depressive Symptoms in Caregivers
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in caregiver depressive symptoms from baseline to 3 month follow-up, measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score ranges from 0 to 27, with higher scores indicating more severe depression and a worse outcome. Each item is scored from 0 (not at all) to 3 (nearly every day).
Baseline, post-intervention, and 3-month follow-up
Child Behavior Checklist (CBCL)
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in child behavior scores from baseline to 3 month follow-up, as reported by caregivers using the Child Behavior Checklist (CBCL). The CBCL is part of the Achenbach System of Empirically Based Assessment and evaluates behavioral and emotional problems in children. Caregivers rate behaviors on a 3-point scale: 0 ("Not True"), 1 ("Somewhat or Sometimes True"), and 2 ("Very True or Often True"). Raw scores are converted to T-scores ranging from 0 to 100. Higher T-scores indicate greater behavioral or emotional problems and a worse outcome.
Baseline, post-intervention, and 3-month follow-up
Observed Child Social Communication
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in child social communication measured using the Brief Observation of Social Communication Change (BOSCC) during standardized caregiver-child interaction activities coded by raters blinded to intervention arm and assessment time point.
Baseline, post-intervention, and 3-month follow-up
Observed Caregiver-Child Interaction Quality
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in caregiver-child interaction quality assessed through structured observational coding of caregiver-child interaction activities using coding procedures informed by Joint Engagement Rating Inventory (JERI) constructs.
Baseline, post-intervention, and 3-month follow-up
Observed Caregiver Strategy Use
Time Frame: Baseline, post-intervention, and 3-month follow-up
Change in caregiver use of communication and behavior-support strategies taught through the Pepea Pamoja intervention during standardized caregiver-child interaction activities.
Baseline, post-intervention, and 3-month follow-up
Autism-Related Functioning
Time Frame: Baseline, post-intervention, and 3-month follow-up.
Change in autism-related functioning measured using the Autism Impact Measure (AIM). The AIM is a caregiver-reported outcome measure designed to assess autism symptom impact and sensitivity to change over time. Higher scores indicate greater autism-related impact.
Baseline, post-intervention, and 3-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention
Time Frame: Post-intervention (6 months)
Assessed using the Acceptability of Intervention Measure (AIM) and items aligned with the Theoretical Framework of Acceptability (TFA). The AIM is a 4-item scale rated from 1 ("completely disagree") to 5 ("completely agree"), total score range 4-20; higher scores indicate greater acceptability. Supplementary qualitative interviews will be coded using a deductive framework based on CFIR and Proctor's IOF to explore perceived acceptability and inform program adaptation.
Post-intervention (6 months)
Feasibility of Intervention - Quantitative Assessment
Time Frame: Post-intervention (6 months)
Feasibility of the caregiver autism intervention, assessed using the Feasibility of Intervention Measure (FIM). The FIM is a validated 4-item scale designed to assess the extent to which an intervention can be successfully used or carried out within a given setting. Each item is rated on a 5-point Likert scale from 1 ("completely disagree") to 5 ("completely agree"), yielding a total score range of 4 to 20. Higher scores indicate greater perceived feasibility and a better outcome.
Post-intervention (6 months)
Feasibility of Intervention - Qualitative Assessment
Time Frame: Post-intervention (6 months)
Feasibility of the caregiver autism intervention, assessed through semi-structured qualitative interviews with caregivers and facilitators. Transcripts will be coded using a deductive codebook aligned with the Consolidated Framework for Implementation Research (CFIR) and constructs from Proctor's Implementation Outcomes Framework (IOF). Thematic analysis will identify perceived acceptability, appropriateness, feasibility, reach, barriers, facilitators, and recommended refinements. Findings will be summarized using a joint diagram supported by illustrative quotes.
Post-intervention (6 months)
Fidelity of Intervention Delivery
Time Frame: 10 weeks
Fidelity of intervention delivery assessed through audio-recorded sessions scored using a standardized fidelity rubric. The rubric evaluates facilitator adherence to core curriculum components, delivery quality, and responsiveness. Fidelity metrics are informed by prior implementation of the Pepea Pamoja and Takia programs. Scores will be aggregated across sessions to produce a mean fidelity score per facilitator. Curriculum adaptations will be documented, and facilitator training will include competency checklists, booster trainings, and structured feedback meetings to support fidelity.
10 weeks
Reach of Intervention
Time Frame: Enrollment through 6-month follow-up
Assessed using eligibility and retention data, including proportion of eligible caregivers who enrolled and completed the intervention.
Enrollment through 6-month follow-up
Appropriateness of Intervention - Quantitative Assessment Using the Implementation Appropriateness Measure
Time Frame: Post-intervention (6 months)
Appropriateness of the caregiver autism intervention, assessed using the Implementation Appropriateness Measure (IAM). The IAM is a validated 4-item scale designed to assess the perceived fit, relevance, or compatibility of an intervention for a specific setting or population. Each item is rated on a 5-point Likert scale from 1 ("completely disagree") to 5 ("completely agree"), yielding a total score range of 4 to 20. Higher scores indicate greater perceived appropriateness and a better outcome.
Post-intervention (6 months)
Appropriateness of Intervention - Qualitative Assessment
Time Frame: Post-intervention (6 months)
Appropriateness of the caregiver autism intervention, assessed through semi-structured qualitative interviews with caregivers and facilitators. Transcripts will be analyzed thematically using a deductive codebook informed by implementation science frameworks, including constructs from the Implementation Outcomes Framework (IOF). Themes will include perceived fit, relevance, and contextual compatibility, supported by illustrative quotes.
Post-intervention (6 months)
Reasons for Attrition
Time Frame: At time of participant withdrawal (if applicable), up to 6 months post-enrollment
Exit interviews conducted with caregivers who discontinue participation to identify barriers to retention.
At time of participant withdrawal (if applicable), up to 6 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Moi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eren Oyungu, MBChB, Moi University
  • Principal Investigator: Megan S. McHenry, MD, MS, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 96463446

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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