Clinical trial NCT06298136: The Effects of an Online Mindfulness-based Intervention for Children with Attention-Deficit/Hyperactivity Disorder
Official title: The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: ADHD
family
mindfulness-based intervention
online intervention
randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2).
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 12.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Child ADHD symptoms
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Secondary outcomes:
measure: Parent depressive symptoms
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Parent anxiety symptoms
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Parent sleep quality
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Parent well-being
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Child executive functioning
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Parental Stress
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
measure: Expressed emotion
timeFrame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Herman Hay Ming Lo
Study officials:
affiliation: Hong Kong Polytechnic University
name: Herman Hay Ming Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References: