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).
Study Goal
The researchers aimed to evaluate the effectiveness of a family-based mindfulness intervention (FBMI) in reducing ADHD symptoms in children and parental stress.
Results Summary
The study is a randomized controlled trial examining FBMI's impact on children's ADHD symptoms, behavior, and parental stress, with secondary measures including behavioral problems, attention performance, and parental mindfulness. Results are pending as the trial is ongoing.
Population
120 children aged 5-7 with ADHD or inattention/hyperactivity symptoms and their parents in Hong Kong.
Effective Dosage
Not specified
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
family-based mindfulness intervention (FBMI) | increase | attention and mental health | children with attention symptoms | - | promote | #1 |
family-based mindfulness intervention (FBMI) | decrease | stress | parents of children with attention symptoms | - | reduce | #2 |
mindfulness training | increase | attention | - | - | improve | #3 |
mindfulness training | increase | cognitive development and overall functioning | - | - | facilitate | #4 |
medication | decrease | growth | preschool children | - | suppress | #5 |
BACKGROUND: About 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/DESIGN: A 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. DISCUSSION: This 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 REGISTRATION: This study is registered with the Chinese Clinical Trial Registry (reference number: ChiCTR-IOR-15007292 ). Registered 28 October 2015.