The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Child ADHD symptoms
研究概览
简要总结
This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.
详细描述
In Hong Kong, 3.9% of adolescents were diagnosed as having Attention Deficit/Hyperactivity Disorder (ADHD). The primary symptoms of ADHD include inattention, hyperactivity, and impulsivity, which limit learning and socioemotional development. ADHD has been associated with poor family functioning, increased stress within the family, higher rates of parental psychopathology, and conflicted parent-child relationships. More than 70% of children with ADHD experience improvements after treatment with psychostimulant medication but some children demonstrate side effects. Behavioral interventions have been found to be effective in enhancing motivation and decreasing the disruptive behaviors of children with ADHD. However, some parents of children with ADHD experience high levels of stress, and the children's symptoms and reactions often complicate their application of the techniques taught in parent behavioral training programs. Moreover, while children benefit from behavioral training in short-term improvements, its long-term effects are uncertain, as children with ADHD cannot learn self-regulation without parental supervision.
In recent reviews and randomized controlled trials, mindfulness-based intervention (MBI) has shown its benefits in improving ADHD symptoms and parent's mental health. Practitioners and researchers have collaborated to apply technology and convert face-to-face MBIs into online or app-based MBIs. Our research team modified the ordinary MBI program structure by integrating short daily online psychoeducation videos with audio mindfulness guidance. In view of the poor engagement and high dropout issues of many online programs, our program is strengthened by incorporating four weekly, real-time online meetings with instructors. The content of MBI includes mindfulness and attention, mindfulness and physical sensation, mindfulness and parental stress, and mindfulness and self-care. The majority of the exercises are for parents, but additional guidance for child-parent mindfulness exercises is included. One module will target children with ADHD and the length of video and audio of mindfulness exercises for children.
This study will investigate the effects of an online MBI, with a randomized controlled trial. A total of 208 parents will be recruited, and randomly assigned to online MBI and psychoeducation. The effects of the MBI will be investigated in comparison with the effects of psychoeducation and outcomes on child ADHD symptoms, parent mental health, and family expressed emotions will be measured. Immediate effect at post-intervention, and 3-month follow-up maintenance effect will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parents of children diagnosed with ADHD by a psychiatrist and psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5)
- •parents of children with ADHD aged 6 to
- •Parents who have served as the primary caregivers of their children in the last year and children with ADHD who speak and understand Cantonese Chinese.
- •Children either not taking any medication or maintaining a stable dosage of the same ADHD medication for at least 3 months prior to study enrollment and having no plans to change medication and dosage during the study period.
排除标准
- •parents diagnosed with developmental disabilities, psychosis, or cognitive impairment, who may thus have difficulty comprehending the content of the project.
- •Children with another developmental disability such as autistic spectrum disorder or intellectual disability.
- •Parents who completed an eight-week MBI or equivalent program.
研究组 & 干预措施
Psychoeducation
The psychoeducation program is based on the Parent Training for Child ADHD Program developed by Russell Barkley for children with ADHD and other behavioral disorders. It includes: (1) understanding ADHD symptoms, (2) general behavior management principles, (3) positive reinforcement and attending skills, (4) the use of a reward and token system, and (5) child problem-solving skills.
干预措施: child behavior management (Behavioral)
Online mindfulness-based intervention (MBI)
The research team have developed an online family MBI (arm 1) for parents and their children with ADHD. It integrates psychoeducation videos (each 3-7 minutes) with audio mindfulness exercises (each 5-15 minutes). The content includes: (1) mindfulness and attention, (2) mindfulness and physical sensation, (3) mindfulness and parental stress, and (4) mindfulness and parental self-care. The majority of the exercises in the first four modules are for parents, but five of them include guidance for child-parent mindfulness exercises. The fifth module targets children with ADHD and the length of video and audio of mindfulness exercises for children, each last 3-5 mins.
干预措施: mindfulness-based intervention (Behavioral)
结局指标
主要结局
Child ADHD symptoms
时间窗: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors rating Scale, minimum value is -54 and maximum value is 54. The higher the score, the severe the symptoms of inattention and hyperactivity.
次要结局
- Parent depressive symptoms(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Parent anxiety symptoms(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Parent sleep quality(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Parent well-being(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Child executive functioning(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Parental Stress(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
- Expressed emotion(Change from pre-intervention, to 1-month follow-up, and 3-month follow-up)
研究者
LO Hay-ming Herman
Associate Professor
The Hong Kong Polytechnic University