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

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.

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.

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.

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.

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.

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).

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.

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.

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).

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.

Change in caregiver use of communication and behavior-support strategies taught through the Pepea Pamoja intervention during standardized caregiver-child interaction activities.

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.

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.

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.

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.

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.

Assessed using eligibility and retention data, including proportion of eligible caregivers who enrolled and completed the intervention.

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.

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.

Exit interviews conducted with caregivers who discontinue participation to identify barriers to retention.