ADHDMindADHDNCT06298136
The Effects of an Online Mindfulness-based Intervention for Children with Attention-Deficit/Hyperactivity Disorder
A study testing mindfulness-based intervention and child behavior management in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ADHD
- What is being tested?
- mindfulness-based intervention and child behavior management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Herman Hay Ming Lo
Hong Kong
Christine Wing Tung Yeung, MSsc, +85266279904, wing-tung.yeung@polyu.edu.hk
About this study
Official title: The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial
This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.
Read the 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.
- Conditions
- ADHD
- Being tested
- mindfulness-based intervention, child behavior management
- Keywords
- ADHD, family, mindfulness-based intervention, online intervention, randomized controlled trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based interventionBehavioural
Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided
child behavior managementBehavioural
worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.
| Study group | Role | What they receive |
|---|---|---|
| Online mindfulness-based intervention (MBI) | Experimental | The research team have developed an online family MBI (arm 1) for parents and their children with ADHD. It integrates psychoeducation videos (each 3-7 minutes) with audio mindfulness exercises (each 5-15 minutes). The content includes: (1) mindfulness and attention, (2) mindfulness and physical sensation, (3) mindfulness and parental stress, and (4) mindfulness and parental self-care. The majority of the exercises in the first four modules are for parents, but five of them include guidance for child-parent mindfulness exercises. The fifth module targets children with ADHD and the length of video and audio of mindfulness exercises for children, each last 3-5 mins. Receives: Behavioral: mindfulness-based intervention |
| Psychoeducation | Active comparator | The psychoeducation program is based on the Parent Training for Child ADHD Program developed by Russell Barkley for children with ADHD and other behavioral disorders. It includes: (1) understanding ADHD symptoms, (2) general behavior management principles, (3) positive reinforcement and attending skills, (4) the use of a reward and token system, and (5) child problem-solving skills. Receives: Behavioral: child behavior management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child ADHD symptoms
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Secondary outcomes (7)
Parent depressive symptoms
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Parent anxiety symptoms
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Parent sleep quality
Insomnia Severity Index. minimum value is 0 and the maximum value is 28. The higher the score, the severe the symptoms of sleep quality.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Parent well-being
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Child executive functioning
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Parental Stress
Parenting Stress Index (short form). minimum value is 36 and the maximum value is 180. The higher the score, the severe the parenting stress.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Expressed emotion
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.
Measured: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LO Hay-ming Herman, The Hong Kong Polytechnic University
- Investigators
- Herman Hay Ming Lo, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298136
- Sponsor's protocol ID
- 15610923
- Acronym
- MindADHD
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published. The data collected in this study excluding personal data can be shared by sending request to principal investigator.
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.
PubMed 40474301
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Online Mindfulness-based Intervention for Parents of Children with Attention-Deficit/Hyperactivity Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06298136
- Acronym / sponsor ID
- MindADHD / 15610923
- Conditions
- ADHD
- Keywords
- ADHD, family, mindfulness-based intervention, online intervention, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Online mindfulness-based intervention (MBI) | Experimental | Behavioral: mindfulness-based interventionThe research team have developed an online family MBI (arm 1) for parents and their children with ADHD. It integrates psychoeducation videos (each 3-7 minutes) with audio mindfulness exercises (each 5-15 minutes). The content includes: (1) mindfulness and attention, (2) mindfulness and physical sensation, (3) mindfulness and parental stress, and (4) mindfulness and parental self-care. The majority of the exercises in the first four modules are for parents, but five of them include guidance for child-parent mindfulness exercises. The fifth module targets children with ADHD and the length of video and audio of mindfulness exercises for children, each last 3-5 mins. |
| Psychoeducation | Active comparator | Behavioral: child behavior managementThe psychoeducation program is based on the Parent Training for Child ADHD Program developed by Russell Barkley for children with ADHD and other behavioral disorders. It includes: (1) understanding ADHD symptoms, (2) general behavior management principles, (3) positive reinforcement and attending skills, (4) the use of a reward and token system, and (5) child problem-solving skills. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based interventionAudio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided | Behavioural | Online mindfulness-based intervention (MBI) |
| child behavior managementworksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided. | Behavioural | Psychoeducation |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40474301Zhang 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.
- Individual participant dataSharing planned: Yes. The study protocol will be published. The data collected in this study excluding personal data can be shared by sending request to principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herman Hay Ming Lo, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based intervention and child behavior management in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herman Hay Ming Lo, PhD (+85296279830, herman.lo@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child ADHD symptoms (time frame: Change from pre-intervention, to 1-month follow-up, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.