An interventional study of Professionally-facilitated groups and Peer-facilitated groups in Autism Spectrum Disorder, Autism and ASD, sponsored by Indiana University. Not yet recruiting at 1 site in Kenya. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 240 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
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.
Time frame: 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.
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Quality of Life in Caregivers
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Quality of Life in Children
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Parenting Stress Index
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Depressive Symptoms in Caregivers
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).
Time frame: Baseline, post-intervention, and 3-month follow-up
Child Behavior Checklist (CBCL)
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Observed Child Social Communication
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Incremental Cost-Effectiveness Ratio (ICER)
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).
Time frame: 3 months
Observed Caregiver-Child Interaction Quality
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.
Time frame: Baseline, post-intervention, and 3-month follow-up
Observed Caregiver Strategy Use
Change in caregiver use of communication and behavior-support strategies taught through the Pepea Pamoja intervention during standardized caregiver-child interaction activities.
Time frame: Baseline, post-intervention, and 3-month follow-up
Autism-Related Functioning
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.
Time frame: Baseline, post-intervention, and 3-month follow-up.
Acceptability of Intervention
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.
Time frame: Post-intervention (6 months)
Feasibility of Intervention - Quantitative Assessment
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.
Time frame: Post-intervention (6 months)
Feasibility of Intervention - Qualitative Assessment
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.
Time frame: Post-intervention (6 months)
Fidelity of Intervention Delivery
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.
Time frame: 10 weeks
Reach of Intervention
Assessed using eligibility and retention data, including proportion of eligible caregivers who enrolled and completed the intervention.
Time frame: Enrollment through 6-month follow-up
Appropriateness of Intervention - Quantitative Assessment Using the Implementation Appropriateness Measure
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.
Time frame: Post-intervention (6 months)
Appropriateness of Intervention - Qualitative Assessment
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.
Time frame: Post-intervention (6 months)
Reasons for Attrition
Exit interviews conducted with caregivers who discontinue participation to identify barriers to retention.
Time frame: At time of participant withdrawal (if applicable), up to 6 months post-enrollment
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