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

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 t-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.