Clinical trial NCT05551728: Autism Caregiver Coaching in Africa
Official title: Autism Caregiver Coaching in Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism or Autistic Traits
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2022-09-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline VABS-3 Communication Domain Standard Score at 6 months
timeFrame: Baseline, 6 months
measure: Change from Baseline Griffiths III Language and Communication Developmental Quotient at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change from Baseline JERI composite score at 4 months
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
state: West Cape
Study officials:
References: