Herman Hay Ming Lo
Hong Kong
Location status: Recruiting
NCT Number: NCT06298136
This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.
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Interventional
Not applicable
Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided
worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.
Time frame: 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.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
The Center for Epidemiologic Studies Depression Scale. minimum value is 0 and the maximum value is 30. The higher the score, the severe the symptoms of depression.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Hospital Anxiety and Depression Scale - Anxiety subscale. minimum value is 0 and the maximum value is 21. The higher the score, the severe the symptoms of anxiety.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Insomnia Severity Index. minimum value is 0 and the maximum value is 28. The higher the score, the severe the symptoms of sleep quality.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
World Health Organization Well-Being Index. minimum value is 0 and the maximum value is 25. The lower the score, the worse in well-being.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Behavior Rating Inventory of Executive Function (second edition). minimum value is 0 and the maximum value is 126. The higher the score, the severe the deficits in executive functioning.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Parenting Stress Index (short form). minimum value is 36 and the maximum value is 180. The higher the score, the severe the parenting stress.
Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
The Five Minute Speech Sample. It is scored by the coding procedure. There is no maximum value. THe higher the score, the severe the parent's expressed emotion.
Contact information is provided by the study sponsor or research team.
Christine Wing Tung Yeung, MSSc
CONTACT
Herman Hay Ming Lo, PhD
CONTACT
The Hong Kong Polytechnic University
Other
The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial
Acronym: MindADHD
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