Duke Center for Autism and Brain Development, Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina, United States of America.
Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America.
PLoS One. 2024 Jan 12;19(1):e0291883. doi: 10.1371/journal.pone.0291883. eCollection 2024.
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.
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.
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.
Participant enrolment started in April 2023. Estimated primary completion date is March 2027.
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.
NCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov).
尽管早期自闭症干预可以显著改善结果，但在全球范围内仍存在实施方面的差距。这些差距在非洲最为明显，到 2050 年，全球将有 40%的儿童生活在非洲。鉴于非洲缺乏专家，将早期干预任务分发给非专业人员是一项关键的实施策略。自然发展行为干预（NDBI）是一类可以由照顾者提供的早期自闭症干预方法。作为解决早期自闭症干预差距的基础步骤，我们对一种非专业人员提供的照顾者教练 NDBI 进行了改编，使其适用于南非的情况，并在现有的护理系统中对这种级联任务分担方法进行了预试点。
首先，我们将测试照顾者教练 NDBI 与常规护理相比的有效性。其次，我们将描述在南非西开普省教育部实施中的教练实施因素。
这是一种 1 型有效性-实施混合设计；评估者盲、分组随机对照试验。参与者包括 150 名患有自闭症的儿童（18-72 个月）及其居住在南非开普敦的照顾者，以及参与干预实施的人员。由教育部雇用的幼儿发展从业者将为干预组提供 12 次，每次 1 小时的教练课程。对照组将接受常规护理。远端主要结局包括沟通领域标准评分（Vineland 适应行为量表，第三版）和语言和沟通发展商数（Griffiths 儿童发展量表，第三版）。近端次要结局包括照顾者策略，通过从联合参与评分量表中五个项目的总和来衡量。我们将描述关键的实施决定因素。
参与者招募于 2023 年 4 月开始。预计主要完成日期为 2027 年 3 月。
ACACIA 试验将确定在教育环境中实施级联任务分担干预是否能显著改善自闭症儿童的沟通能力，并确定实施的障碍和促进因素。
NCT05551728 在临床试验注册处（https://clinicaltrials.gov）。
