Autism spectrum disorder affects 1-2% of children worldwide, yet access to quality care remains limited, especially in underserved communities. Families face systemic barriers such as workforce shortages, high caregiver stress, and a lack of culturally appropriate services. To address these gaps, researchers developed a group-based caregiver training program to improve caregiver well-being and child communication and behavior. Successfully piloted in rural U.S. communities and western Kenya through the AMPATH Program, the intervention showed promising results in reducing caregiver stress and autism severity. Building on this success, a new study will evaluate two delivery models-professionally-led and peer-led-using a rigorous effectiveness-implementation trial. The project applies a reciprocal innovation approach, using insights from Kenya to inform U.S. strategies for scaling community-based autism support. The long-term goal is to reduce disparities in autism care by creating scalable, low-cost, caregiver-driven models. A Community Advisory Panel will guide the research to ensure relevance and impact. This initiative represents a transformative step toward equitable autism services across global and U.S. settings.
Autism spectrum disorder is a common neurodevelopmental disability affecting 1-2% of children worldwide. While early intervention is critical for improving outcomes, access to quality services remains severely limited. Families in low-resource settings, both globally and within the U.S, face systemic barriers including workforce shortages, high caregiver burden, and limited culturally appropriate services. There is a critical need for scalable low-cost interventions to support children with autism and their families in communities where robust systems of care are absent. To address this gap, researchers developed a group-based caregiver training intervention to support caregiver well-being and communication and behavior in children with autism. Piloted successfully in rural U.S. and western Kenya through the Academic Model Providing Access to Healthcare (AMPATH) Program, the intervention demonstrated feasibility, acceptability, and improvements in caregiver stress, child communication and behavior scores, and autism severity scores. Building on this foundation, researchers propose a Hybrid Type 2 effectiveness-implementation trial to rigorously evaluate both the intervention's effectiveness of improving child and caregiver outcomes and the implementation strategies needed for sustainable scale-up across health systems. The researchers embed a reciprocal innovation approach, leveraging insights from Kenya to inform U.S. communities facing similar challenges. Specifically, lessons learned from scaling peer-led delivery models in Kenya, where scare autism resources exist, will directly inform efforts to expand community-based autism support services in underserved areas of the U.S., where similar implementation challenges persist and services are variable. The long-term goal is to reduce disparities in autism care and outcomes by developing scalable, community-driven caregiver support models. The researchers will bring together a Community Advisory Panel to ensure clinical and scientific rigor to maximize translation of findings. The overall objective of this study is to evaluate the effectiveness and implementation outcomes, including cost-effectiveness, of professional-led versus peer-led caregiver support for children with autism in Kenya, and to leverage lessons learned to reciprocally pilot-test the peer-led intervention in the U.S. To achieve this objective, the investigators propose the following Aims: Aim 1: Evaluate the effectiveness of a group-based caregiver training program on caregiver and child outcomes in Kenya. Approach: Investigators will conduct a cluster randomized trial comparing two delivery strategies for a caregiver-focused autism intervention, either (1) structured delivery by trained professionals (e.g. therapists, teachers) using standardized scripts and materials, or (2) peer-led delivery by trained caregivers of children with autism with guided instruction; with a staggered wait-list control. Outcomes will be assessed for caregivers (quality of life (QOL), stress/burden, depressive symptoms) and children (functional communication, behavioral challenges, QOL) at enrollment, pre-/post-intervention, and 3-month follow-up. The investigators hypothesize that the caregiver training program will lead to sustained improvements in caregiver and child outcomes overall, and peer-led delivery of the intervention will be non-inferior to professional-led delivery, supporting its potential for scalability and sustainability. Aim 2: Determine and compare key implementation outcomes, including cost-effectiveness, between two intervention delivery strategies-in-person, professional- vs. peer-led caregiver groups. Approach: Guided by the Consolidated Framework for Implementation Research (CFIR), investigators will use mixed-methods to analyze implementation outcomes of both intervention delivery strategies, including cost-effectiveness, fidelity, acceptability, feasibility, among others. A community advisor board will guide interpretation. The investigators hypothesize that while acceptability and appropriateness may be similar between the two delivery strategies, the trained peer-led delivery will demonstrate greater feasibility and lower cost, providing key insights to support piloting and scale-up in the U.S. Aim 3: Optimize and pilot a peer-led autism caregiver intervention in the U.S., measuring key effectiveness and implementation outcomes to support scale-up in U.S. underserved settings. Approach: The investigators will use an implementation science and ecological validity framework adaptation process to revise the peer-led program for delivery in the U.S. Building on lessons from the Kenya, trained peers will deliver the adapted pilot program in Virginia. The investigators will use an explanatory sequential mixed-methods approach to evaluate effectiveness and implementation outcomes. The investigators hypothesize that the peer-led model will be feasible, acceptable, and delivered with high fidelity in U.S. under-served settings, with effectiveness, demonstrating reciprocal innovation from Kenya to the U.S. and provide key foundational insights for future scale-up. This study's innovation lies in that it will be among the first rigorous evaluations of a scalable, caregiver-mediated autism intervention in low-resourced settings using an implementation science framework. Lessons learned from scaling peer-led delivery models in Kenya, where children receive very few services for autism, can directly inform efforts to expand community-based autism support services in underserved areas of the U.S., where similar implementation challenges persist and services are variable, for significant impact. This bidirectional learning model represents a transformative approach to developing and delivering scalable, equitable autism care throughout the U.S. and globally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
320
A group-based caregiver ASD intervention will be delivered through two distinct implementation strategies led by trained therapists or teachers using a structured 10-week in-person curriculum at the MTRH campus and virtually in the US.
A group-based caregiver ASD intervention will be delivered through two distinct implementation strategies led by trained caregivers of children with ASD who deliver the same core curriculum with flexibility in timing and location, provided that all content is completed within four months.
University of Virginia (Virtual)
Charlottesville, Virginia, United States
Moi Teaching and Referral Hospital
Eldoret, Kenya
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 and 3 months
Autism Impact Measure (AIM)
Change in caregiver-reported communication and symbolic behavior from baseline to 3 months, measured using the Autism Impact Measure (AIM), which integrates domains from the Communication and Symbolic Behavior Scale (CSBS). The AIM is a validated caregiver-report tool assessing autism-related behaviors across five domains, including communication and social reciprocity. The CSBS is a norm-referenced, standardized instrument that evaluates early communication development through 22 rating scales grouped into seven clusters: communicative functions, gestural and vocal means, verbal means, reciprocity, social-affective signaling, and symbolic behavior. Higher AIM scores indicate greater autism-related impact.
Time frame: Baseline and 3 months
Quality of Life in Caregivers
Change in caregiver-reported quality of life from baseline to 3 months, 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 and 3 months
Quality of Life in Children
Change in caregiver-reported quality of life for children from baseline to 3 months, 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 and 3 months
Parenting Stress Index
Change in parenting stress from baseline to 3 months, 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 and 3 months
Depressive Symptoms in Caregivers
Change in caregiver depressive symptoms from baseline to 3 months, 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 and 3 months
Child Behavior Checklist (CBCL)
Change in child behavior scores from baseline to 3 months, 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 and 3 months
Delivery Method Comparison: Peer-led vs Professional-led Intervention
Comparison of effectiveness between peer-led and professional-led delivery of the caregiver autism intervention using a non-inferiority approach. The estimand is the mean difference in baseline-adjusted communication scores at 3 months, measured using the Communication and Symbolic Behavior Scale (CSBS). The CSBS is a norm-referenced, standardized instrument that evaluates early communication development across 22 rating scales grouped into seven clusters: communicative functions, gestural and vocal means, verbal means, reciprocity, social-affective signaling, and symbolic behavior. Higher scores indicate more advanced communication skills and a better outcome.
Time frame: 3 months
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
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