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Clinical Trials/NCT06298136
NCT06298136
Recruiting
N/A

The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial

The Hong Kong Polytechnic University1 site in 1 country208 target enrollmentFebruary 1, 2024
ConditionsADHD

Overview

Phase
N/A
Intervention
Not specified
Conditions
ADHD
Sponsor
The Hong Kong Polytechnic University
Enrollment
208
Locations
1
Primary Endpoint
Child ADHD symptoms
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LO Hay-ming Herman

Associate Professor

The Hong Kong Polytechnic University

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
  • 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.

Outcomes

Primary Outcomes

Child ADHD symptoms

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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