Abstract
Background While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world’s children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care.
Objectives First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa.
Methods This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants.
Results Participant enrolment started in April 2023. Estimated primary completion date is March 2027.
Conclusion The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators.
Trial registration NCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov)
Competing Interest Statement
I have read the journal's policy and the authors of this manuscript have the following competing interests. Drs. Geraldine Dawson and Guillermo Sapiro, who are investigators on this project, have developed a technology that is being used in the study. If the technology is commercially successful in the future, the developers and Duke University may benefit financially.
Clinical Trial
Trial registration: NCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov)
Clinical Protocols
https://clinicaltrials.gov/study/NCT05551728
Funding Statement
The study is funded by the National Institute of Health (https://www.nih.gov/). Grant number: R01MH127573 (LF). The funder did not play any role in the study design, decision to publish, or preparation of the manuscript.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This study has been approved by the University of Cape Town Human Research Ethics Committee (HREC REF:367/2022) and Duke University Health System Institutional Review Board (Pro00111048).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
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Yes
Data Availability
Deidentified research data will be made publicly available when the study is completed and published.