Autism Caregiver Coaching in Africa

Study Overview
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Brief Summary
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Around the world there is a growing need to develop early intervention services in local communities that support a better quality of life for all autistic people. The South African study will test an approach where caregivers are coached by non-specialists in early intervention strategies. Caregivers can then use these strategies during everyday activities with their young autistic child.

Detailed Description
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Globally there is a growing need to implement community-based services that support improvements in quality of life of autistic people. Early autism intervention is critical because it can significantly improve both child and family outcomes, but implementation gaps exist worldwide. These gaps are starkest in Africa, where by 2050, forty percent of the world's children will live. Given the lack of specialists in Africa, task shifting early autism intervention to non-specialists will be a key implementation strategy. Naturalistic Developmental Behavioral Interventions (NDBI), are a class of early autism intervention approaches, that can be effectively delivered by caregivers. Through a partnership between Duke University and the University of Cape Town, the team laid the groundwork for an innovative and scalable coaching intervention for young autistic children. A caregiver coaching NDBI was systematically adapted for the South African context in which coaching is effectively delivered by non-specialist Early Childhood Development practitioners employed by the Education Department. The proposed study will build on this foundational work by conducting a type 1 hybrid effectiveness implementation trial of the coaching intervention, delivered by non-specialists, within an existing system of care in South Africa. The goal is to implement a feasible, scalable early autism intervention model in Africa by conducting research with culturally and linguistically diverse participants in community-based settings, that is inclusive of diverse stakeholder perspectives and incorporates task-shifting. The proposed study will build on current relationships with families, practitioners, and policy makers by formalizing these relationships and including other key stakeholder groups such as South African autistic self-advocates through a community-academic partnership, a key bridging factor in the EPIS (Exploration, Preparation, Implementation, Sustainment) implementation framework. The proposed project has three main objectives. First, to evaluate the real-world effectiveness of non-specialist delivered NDBI caregiver coaching for improving patterns of caregiver-child interaction and child developmental outcomes, and assess the cost-effectiveness of this approach. Second, to identify implementation determinants to inform scale-up. Third, to expand African autism research capacity to enhance scalability. This project also offers a unique opportunity to study variability in autism-related behaviors and phenomenology. The study will therefore assess the degree to which response to intervention is moderated by caregiver and dimensional child characteristics. In addition, using an innovative digital assessment method, changes in dimensional quantitative measures of autism-related behaviors will be examined. Finally, cross-cultural differences in dimensional autism-related behaviors will be evaluated via comparison with existing quantitative phenotypic data gathered in U.S. studies. This study is timely and innovative and will inform scale-up of autism early intervention in Africa. Assessing the impact of a scalable intervention in an environment like South Africa which faces significant contextual challenges, increases the ecological validity and relevance of findings for many regions of the world that face with similar challenges.

Official Title
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Autism Caregiver Coaching in Africa

Conditions
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Autism or Autistic Traits

Intervention / Treatment
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* Behavioral: ESDM-informed caregiver coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child's age is 18-72 months Child meets DSM-5 criteria for autism spectrum disorder (ASD), informed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Child's caregiver speaks isiXhosa, isiZulu, Afrikaans, or English Child's race is African or Coloured (South African term for mixed race) Caregiver-child dyad live in recruitment area Caregiver is ≥18 years Exclusion Criteria: Genetic disorder of known etiology (e.g., fragile X syndrome) Significant sensory or motor impairment that would preclude use of the play materials Major physical abnormalities that would interfere with participation in the intervention History of serious head injury and/or neurological disease Caregiver indicates they will be unable to attend assessments and 12 sessions

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design will be an individually randomized group treatment RCT with a delayed treatment control group. 150 children, ages 18-72 months, with a DSM-5 diagnosis of autism spectrum disorder (ASD) and their caregivers will be recruited on a rolling basis, with arm allocation (coaching vs. delayed treatment control) conducted using a minimization approach with child sex balanced across groups. The intervention will be offered to the delayed treatment control group immediately after follow-up assessment (6-months after baseline). Offering the intervention to both groups is of ethical importance in an environment with few services and will enhance retention. Once control dyads have completed the intervention, the degree to which the trend in the control group is consistent with any treatment effect detected in the main trial comparison will be assessed. Note that a total of 320 participants will be enrolled in the study (150 caregiver-child dyads and 20 Aim 2 participants).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>12, 1-hour ESDM-informed caregiver coaching sessions, delivered by non-specialists. Intervention materials and approach have been adapted for the South African context. | Behavioral: ESDM-informed caregiver coaching<br>* The coaching intervention is informed by the Community-Early Start Denver Model (C-ESDM). The intervention has been adapted for the South African context. Training procedures have been adapted for delivery by non-specialist coaches. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) have been developed. Over 12, 1-hour caregiver coaching sessions that are delivered by non-specialists, caregivers are coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors.<br>|
| No Intervention: Delayed intervention control group<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline VABS-3 Communication Domain Standard Score at 6 months | The Vineland Adaptive Behavior Scales-3 (VABS-3) is a semi-structured, clinician-administered, caregiver interview that assesses the degree to which a child routinely performs specified adaptive behaviors compared to age-based norms, and yields standard scores for each subscale as well as an overall composite score. The measure examines domains of communication (receptive, expressive, and written language skills), socialization (play, interpersonal relationships, and coping skills),daily living skills (personal, domestic, and community living skills), and motor skills (gross and fine motor). Subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. | Baseline, 6 months | 
| Change from Baseline Griffiths III Language and Communication Developmental Quotient at 6 months | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive clinician-administered developmental measure designed for evaluation of children ranging in ages from birth to eight years. The Griffiths-III provides a profile of both strengths and weaknesses in child development across 5 domains: foundations of learning, language, and communication (expressive/receptive and social), eye and hand coordination (fine motor skills and visual perception), personal-social-emotional (emotional development and social interactions), and gross motor (postural control, balance, and body coordination). Developmental quotients (DQs) will be calculated by (Developmental Age/Chronological Age) *100, and range from 0-100 with higher scores indicating a higher degree of congruence between child developmental and chronological age. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline JERI composite score at 4 months | The Joint Engagement Rating Inventory (JERI) is a behavioral coding scheme designed to measure multiple aspects of caregiver-child interactions. The JERI includes 32 items rated on a 7-point Likert scale across four categories: 1) child engagement state items, 2) child activity items, 3) caregiver activity items, and 4) dyadic interaction items. For this study a JERI composite score will include the sum of 5 caregiver activity items including: scaffolding, following the child's interests, affect, language facilitation, and use of communicative temptations. Each caregiver activity item is rated on a 1-7 scale, with 1 indicating a low frequency and quality of the behavior and 7 indicating a high frequency and quality of the behavior. | Baseline, 4 months |