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Recruiting NCT06298136

The Effects of an Online Mindfulness-based Intervention for Children with Attention-Deficit/Hyperactivity Disorder

No phase Interventional ADHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mindfulness-based intervention, child behavior management.
Who it may be relevant to
Registry conditions: ADHD. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral mindfulness-based intervention
    Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided
  • Behavioral child behavior management
    worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.

Primary outcome measures

  • Child ADHD symptoms [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
Secondary outcome measures (7)
  • Parent depressive symptoms [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Parent anxiety symptoms [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Parent sleep quality [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Parent well-being [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Child executive functioning [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Parental Stress [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]
  • Expressed emotion [Time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Herman Hay Ming Lo — Hong Kong

Publications

  • Zhang ZJ, Lo HHM, Bogels SM, Cheung RYM, Lau EN, Lee EK, Ng SM, Au A, Yeung WT. A randomized controlled trial for evaluating the effects of an online mindfulness-based intervention for parents of children with attention-deficit/hyperactivity disorder: a study protocol. BMC Psychol. 2025 Jun 5;13(1):610. doi: 10.1186/s40359-025-02929-0. PMID 40474301

Identifiers

NCT: NCT06298136 · 15610923

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗