Franz Lauren, Viljoen Marisa, Askew Sandy, Brown Musaddiqah, Dawson Geraldine, Di Martino J Matias, Sapiro Guillermo, Sebolai Katlego, Seris Noleen, Shabalala Nokuthula, Stahmer Aubyn, Turner Elizabeth L, de Vries Petrus J
Duke Center for Autism and Brain Development, Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina, USA.
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.
medRxiv. 2023 Sep 11:2023.09.10.23295331. doi: 10.1101/2023.09.10.23295331.
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.
虽然早期自闭症干预可显著改善预后，但全球范围内在干预实施方面仍存在差距。这些差距在非洲最为明显，到2050年，全球40%的儿童将生活在非洲。鉴于非洲缺乏专业人员，将早期干预任务分担给非专业人员是一项关键的实施策略。自然主义发展行为干预（NDBI）是一类可由照料者实施的早期自闭症干预措施。作为解决早期自闭症干预差距的基础步骤之一，我们针对南非的情况改编了一种由非专业人员实施的照料者指导的NDBI，并在现有的照护体系中对这种级联式任务分担方法进行了预试验。
第一，我们将测试照料者指导的NDBI与常规照护相比的有效性。第二，我们将描述南非西开普省教育部内的指导实施因素。
这是一项1型有效性-实施混合设计；评估者设盲、组群随机对照试验。参与者包括150名自闭症儿童（18 - 72个月）及其居住在南非开普敦的照料者，以及参与干预实施的人员。由教育部聘用的幼儿发展从业者将为干预组提供12次，每次1小时的指导课程。对照组将接受常规照护。远端共同主要结局包括沟通领域标准分数（《文兰适应行为量表》第三版）和语言与沟通发展商数（《格里菲斯儿童发展量表》第三版）。近端次要结局包括通过《联合参与评定量表》中五个项目的总和来衡量的照料者策略。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的级联式任务分担干预是否能使自闭症儿童的沟通能力得到有意义的改善，并识别实施障碍和促进因素。
