Hinten Ashley E, Schluter Philip J, van Deurs Jenna, van Noorden Lauren, McLay Laurie
Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand.
School of Clinical Medicine, Primary Care Clinical Unit, The University of Queensland, Brisbane, Queensland, Australia.
BMJ Open. 2025 May 15;15(5):e081030. doi: 10.1136/bmjopen-2023-081030.
Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand's Let's Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children's learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let's Play programme on autistic children's engagement and caregiver stress.
This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0-5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let's Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.
This trial was approved by Aotearoa New Zealand Ministry of Health's Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.
ACTRN12622001139763.
大量实证证据凸显了对自闭症儿童进行早期识别、诊断和支持的重要性。自闭症儿童的照料者常常承受着高水平的心理困扰；因此，需要同时为儿童及其照料者提供支持。新西兰自闭症协会的“一起玩耍”项目是一个由照料者介导的、基于社区的项目，该项目基于发展性和关系性干预原则（以下简称“发展性原则”）。发展性干预是基于证据的支持措施，旨在在适合儿童发展的自然环境（如日常活动、玩耍）中促进儿童学习。我们旨在评估“一起玩耍”项目对自闭症儿童参与度和照料者压力的影响。
本研究将是一项单盲（评估者）随机对照试验，设有两个平行组：立即参与项目（干预组）与等待名单对照组。根据功效计算，参与者将是64名0至5岁被诊断或疑似患有自闭症儿童的照料者，允许有20%的损耗率。“一起玩耍”项目将通过小组研讨会和家庭指导相结合的方式，在9周内实施。主要结局变量包括儿童参与度和照料者压力。照料者将在三个时间点（基线、项目结束后立即以及6个月随访时）完成测量，有效性将使用广义估计方程模型以及意向性分析和符合方案分析进行分析。
本试验已获得新西兰卫生部健康与残疾伦理委员会批准（2022 FULL 13041）。研究结果将通过会议、期刊发表以及利益相关者团体（如自闭症儿童服务提供者）在国内和国际上进行交流。无论效果大小或方向如何，结果都将予以公布。
ACTRN12622001139763。
