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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06298136
Acronym
MindADHD
Enrollment
208
Registered
2024-03-07
Start date
2024-02-01
Completion date
2026-12-31
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, family, mindfulness-based intervention, online intervention, randomized controlled trial

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.

Interventions

BEHAVIORALmindfulness-based intervention

Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided

BEHAVIORALchild behavior management

worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

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).

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Child ADHD symptomsChange from pre-intervention, to 1-month follow-up, and 3-month follow-upStrengths 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

MeasureTime frameDescription
Parent anxiety symptomsChange from pre-intervention, to 1-month follow-up, and 3-month follow-upHospital 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.
Parent sleep qualityChange from pre-intervention, to 1-month follow-up, and 3-month follow-upInsomnia Severity Index. minimum value is 0 and the maximum value is 28. The higher the score, the severe the symptoms of sleep quality.
Parent well-beingChange from pre-intervention, to 1-month follow-up, and 3-month follow-upWorld Health Organization Well-Being Index. minimum value is 0 and the maximum value is 25. The lower the score, the worse in well-being.
Parent depressive symptomsChange from pre-intervention, to 1-month follow-up, and 3-month follow-upThe 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.
Parental StressChange from pre-intervention, to 1-month follow-up, and 3-month follow-upParenting Stress Index (short form). minimum value is 36 and the maximum value is 180. The higher the score, the severe the parenting stress.
Expressed emotionChange from pre-intervention, to 1-month follow-up, and 3-month follow-upThe 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.
Child executive functioningChange from pre-intervention, to 1-month follow-up, and 3-month follow-upBehavior 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.

Countries

Hong Kong

Contacts

Primary ContactHerman Hay Ming Lo, PhD
herman.lo@polyu.edu.hk+85296279830
Backup ContactChristine Wing Tung Yeung, MSSc
wing-tung.yeung@polyu.edu.hk+85266279904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026