针对被诊断为神经发育障碍或神经发育障碍可能性增加的儿童的父母的在线养育接纳与承诺疗法（PACT Online）：一项随机对照试验的研究方案
Parenting Acceptance and Commitment Therapy Online (PACT Online) for parents of children diagnosed with or with increased likelihood of neurodevelopmental disability: study protocol of a randomised controlled trial.
作者信息
Whittingham Koa, Kirby Grace, Boyd Roslyn N, Novak Iona, Mitchell Amy E, Reid Natasha, Keramat Syed Afroz, Hudry Kristelle, Barbaro Josephine, Barfoot Jacqui, Ware Robert S, Russo Fiona, Heussler Helen, McGlade Andrea, Bullot Ashleigh, MacDonald Megan, Tran Tommy, Harrington Sophie, Sheffield Jeanie, Olson Rebecca, Costa Nathalia
机构信息
Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia
Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
出版信息
BMJ Open. 2025 Jun 20;15(6):e088981. doi: 10.1136/bmjopen-2024-088981.
INTRODUCTION
Approximately 1 in 13 Australian children have a neurodevelopmental disability. This project aims to assess the effectiveness and implementation of an online parenting support programme, Parenting Acceptance and Commitment Therapy () for parents of children with neurodevelopmental disabilities for improving the parent-child relationship and parent and child outcomes.
METHODS AND ANALYSIS
This hybrid type 1 randomised controlled trial will focus on evaluating intervention effectiveness and understanding the context for implementation. The primary outcome is observed emotional availability within parent-child interactions assessed at postintervention (12 weeks postbaseline) with additional measurement at follow-up (6 months postbaseline). Secondary outcomes include (1) parent-reported emotional availability, (2) parental mindfulness, (3) parent mental health, (4) psychological flexibility, (5) adjustment to child's disability, (6) health behaviour and (7) regulatory abilities as well as child outcomes of (1) mental health, (2) adaptive behaviour and (3) regulatory abilities. Evaluation of implementation will include an economic evaluation of costs and consequences, and an implementation analysis grounded in the consolidated framework for implementation research with a focus on contextual factors influencing implementation.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the University of Queensland Human Research Ethics Committee (023/HE000040). Dissemination of study outcomes will occur through the appropriate scientific channels. Long-term implementation will be grounded within the implementation analysis and occur in partnership with the partner organisations and consumer engagement panel. This will include releasing the intervention as a massive open online course on the edX platform if support for intervention effectiveness and implementation is found.
TRIAL REGISTRATION NUMBER
ACTRN12623000612617; this trial has been registered with the Australian New Zealand Clinical Trials Registry.
引言
大约每13名澳大利亚儿童中就有1名患有神经发育障碍。本项目旨在评估一项在线育儿支持计划——育儿接纳与承诺疗法（ ）对神经发育障碍儿童家长的有效性及实施情况，以改善亲子关系及家长和孩子的相关结果。
方法与分析
这项1型混合随机对照试验将聚焦于评估干预效果并了解实施背景。主要结局是在干预后（基线后12周）评估的亲子互动中观察到的情感可及性，并在随访时（基线后6个月）进行额外测量。次要结局包括：（1）家长报告的情感可及性；（2）家长正念；（3）家长心理健康；（4）心理灵活性；（5）对孩子残疾的适应情况；（6）健康行为；（7）调节能力，以及孩子的结局，包括（1）心理健康；（2）适应性行为；（3）调节能力。实施情况评估将包括对成本和后果的经济评估，以及基于实施研究综合框架的实施分析，重点关注影响实施的背景因素。
伦理与传播
已获得昆士兰大学人类研究伦理委员会的伦理批准（023/HE000040）。研究结果将通过适当的科学渠道传播。长期实施将基于实施分析，并与合作组织及消费者参与小组合作进行。如果发现该干预措施在有效性和实施方面得到支持，这将包括在edX平台上发布育儿接纳与承诺疗法干预措施作为大规模开放在线课程。
试验注册号
ACTRN12623000612617；本试验已在澳大利亚新西兰临床试验注册中心注册。
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