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The effect of a family-based mindfulness intervention on children with attention deficit and hyperactivity symptoms and their parents: design and rationale for a randomized, controlled clinical trial (Study protocol)

H. Lo, S. Wong, J. Wong, Simpson W. L. Wong, J. W. Yeung

BMC Psychiatry March 15, 2016 DOI: 10.1186/s12888-016-0773-1 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial (study protocol) Peer reviewed
Sample size 120
Population Children aged 5 to 7 with ADHD or symptoms of inattention and hyperactivity, meeting or exceeding the borderline cutoff on the Chinese version of the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors Rating Scale (SWAN-C), and their parents in Hong Kong
Intervention Family-based mindfulness intervention (FBMI)
Duration 8-week intervention; trial conducted from mid-2015 to mid-2016
Measures Chinese version of the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors Rating Scale (SWAN-C), Attention Network Test
Topics Meditation
Key findings The article describes the design of a multicenter, 8-week, waitlist-controlled randomized trial of a family-based mindfulness intervention (FBMI) for children with ADHD symptoms and their parents. The authors propose that if the hypotheses are confirmed, FBMI may serve as an additional treatment option for children with ADHD.

Abstract

BackgroundAbout 4 % of children in Hong Kong have attention deficit hyperactivity disorder (ADHD). The parents of children with ADHD report higher levels of stress and show more negative parenting behavior. Medication and behavior training are evidence-based treatments, but both show significant limitations. In short, medical treatment is not suitable for preschool children and would suppress growth, whereas parents under stress may not be capable of consistently applying behavior management skills. Mindfulness training can improve attention and facilitate cognitive development and overall functioning. It has been widely adopted as a treatment option in health care, but its application in a family context is limited. In this context, a family-based mindfulness intervention (FBMI) has been developed to promote the attention and mental health of children with attention symptoms and to reduce the stress experienced by their parents. This article describes the design and conduct of the trial.Methods/designA multicenter, 8-week, waitlist, randomized controlled trial of FBMI is currently being conducted in Hong Kong (from mid-2015 to mid-2016). Its effectiveness will be examined by comparing the participants who receive treatment to those in a waitlist control group. The study population consists of one hundred twenty children with ADHD, or with symptoms of inattention and hyperactivity, between 5 and 7 years of age and their parents. To be included in the study, the children are required to meet or exceed the borderline cutoff score of the Chinese version of the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors Rating Scale (SWAN-C). The primary outcome measures are the children’s ADHD symptoms and behavior and the parents’ stress. The secondary outcome measures include the children’s overall behavioral problems and performance on the Attention Network Test, the parents’ ADHD symptoms, the parents’ mindful parenting scores, and heart rate variability of parents.DiscussionThis study is probably the first randomized controlled trial of FBMI for young children and their caregivers. A rigorous design and multiple outcome measures are used to examine the effectiveness of FBMI. If the hypotheses are confirmed, FBMI may serve as an additional treatment option for children with ADHD.Trial registrationThis study is registered with the Chinese Clinical Trial Registry (reference number: ChiCTR-IOR-15007292). Registered 28 October 2015.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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