ASD, Autism, Autism Spectrum Disorder
Conditions
Keywords
Caregiver Intervention, Training, Children, Low Resource, Disability, Early Intervention
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.
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.
Interventions
BEHAVIORALProfessionally-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.
BEHAVIORALPeer-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.
Sponsors
Indiana University
Moi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family Burden and Stress | 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. |
| Child Functional Communication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Caregivers | 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. |
| Quality of Life in Children | 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. |
| Parenting Stress Index | 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. |
| Depressive Symptoms in Caregivers | 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). |
| Child Behavior Checklist (CBCL) | 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. |
| Observed Child Social Communication | 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. |
| Incremental Cost-Effectiveness Ratio (ICER) | 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). |
| Observed Caregiver-Child Interaction Quality | 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. |
| Observed Caregiver Strategy Use | 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. |
| Autism-Related Functioning | 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. |
Countries
Kenya
Contacts
CONTACTAnanda Ombitsa
CONTACTKristen Cunningham, MPH, MS
PRINCIPAL_INVESTIGATOREren Oyungu, MBChB
Moi University
PRINCIPAL_INVESTIGATORMegan S. McHenry, MD, MS
Indiana University
Outcome results
None listed