一项评估基于正念的在线干预对注意力缺陷多动障碍儿童家长影响的随机对照试验：研究方案
A randomized controlled trial for evaluating the effects of an online mindfulness-based intervention for parents of children with attention-deficit/hyperactivity disorder: a study protocol.
作者信息
Zhang Zoe Jiwen, Lo Herman Hay Ming, Bögels Susan M, Cheung Rebecca Y M, Lau Elsa Ngar-Sze, Lee Eric Kam-Pui, Ng Siu-Man, Au Alma, Yeung Wing Tung
机构信息
Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong, China.
Faculty of Social and Behavioural Sciences, University of Amsterdam, Amsterdam, Netherlands.
出版信息
BMC Psychol. 2025 Jun 5;13(1):610. doi: 10.1186/s40359-025-02929-0.
BACKGROUND
Childhood attention-deficit/hyperactivity disorder (ADHD) has been associated with poor family functioning and higher risks of conflicts in parent-child relationships. Mindfulness-based intervention (MBI) has been evaluated for its benefits in improving family functioning and has been increasingly applied within the context of a family environment. Furthermore, online MBIs have been developed and combined with multiple technologies used by practitioners and researchers due to their lower cost, ability to overcome geographic restrictions, and capacity to mitigate the impacts of unpredictable events such as the COVID-19 pandemic. Given the limitations of current online MBI research such as the absence of control groups, small sample sizes, and a low completion rate, this study aims to evaluate the effects of an online family MBI on the outcomes of children with ADHD and their parents.
METHODS
This study is a two-arm randomized controlled trial (RCT) study, comparing online family MBI (arm 1) and an online psychoeducation program (arm 2) designed for parents and their ADHD children. The outcome measures of child ADHD symptoms, child executive functioning, parent mental health, sleep quality, and family expressed emotions will be assessed before the interventions (T0), immediately after the interventions at 4 weeks (T1), and at three-month after interventions (T2). Intent-to-treat principle will be used to conduct quantitative data analysis. Chi-squared difference tests and -tests will be performed to compare the differences between groups, and a linear mixed model will be conducted to examine the time effects and time × group effects. Mediation analysis will be conducted to see the mediating roles of parental stress and expressed emotions of parents.
DISCUSSION
This study transfers the promising effect of online MBI to clinical populations, particularly for parents of children with chronic conditions, and the children themselves. By examining expressed emotions within the family context, the findings might shed light on the mechanism of the online MBI in affecting the mental health outcomes of parents and the ADHD symptoms and executive functioning of their children.
TRIAL REGISTRATION
This study has been registered with ClinicalTrials.gov (NCT06298136||https://www.clinicaltrials.gov/). The registration date was 7th March, 2024.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1186/s40359-025-02929-0.
背景
儿童注意力缺陷多动障碍（ADHD）与家庭功能不良及亲子关系冲突风险较高有关。基于正念的干预（MBI）已被评估其在改善家庭功能方面的益处，并越来越多地应用于家庭环境中。此外，由于在线MBI成本较低、能够克服地理限制以及能够减轻诸如COVID-19大流行等不可预测事件的影响，因此已经开发了在线MBI并将其与从业者和研究人员使用的多种技术相结合。鉴于当前在线MBI研究存在对照组缺失、样本量小和完成率低等局限性，本研究旨在评估在线家庭MBI对ADHD儿童及其父母结局的影响。
方法
本研究是一项双臂随机对照试验（RCT），比较在线家庭MBI（第1组）和为父母及其ADHD儿童设计的在线心理教育项目（第2组）。将在干预前（T0）、干预后4周即刻（T1）和干预后三个月（T2）评估儿童ADHD症状、儿童执行功能、父母心理健康、睡眠质量和家庭表达性情绪等结局指标。将采用意向性分析原则进行定量数据分析。将进行卡方差异检验和t检验以比较组间差异，并将进行线性混合模型以检验时间效应和时间×组效应。将进行中介分析以观察父母压力和父母表达性情绪的中介作用。
讨论
本研究将在线MBI的积极效果推广至临床人群，特别是患有慢性病儿童的父母及其子女本身。通过在家庭环境中考察表达性情绪，研究结果可能会揭示在线MBI影响父母心理健康结局以及其子女ADHD症状和执行功能的机制。
试验注册
本研究已在ClinicalTrials.gov（NCT06298136||https://www.clinicaltrials.gov/）注册。注册日期为2024年3月7日。
补充信息
在线版本包含可在10.1186/s40359-025-02929-0获取的补充材料。
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