Stress, PsychologicalNCT06210113
Training Parents of Children With ADHD by Mindfulness-based Stress Reduction for Reducing Stress
A study testing Mindfulness-based Stress Reduction in people with Stress, Psychological, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The study aimed at comparing the effects of 8-week MBSR programme intervention group with usual care group in reducing parental stress and improving quality of life of parents of children with ADHD in Chinese culture. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Mindfulness-based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 who have a child aged 3-12 with a confirmed diagnosis of ADHD with or without medications
- able to communicate and understand Cantonese
Who cannot join
- having physical disabilities or severe intellectual impairments
- any forms of mental disorders
- receiving any other form of psychological intervention, behavioural treatment, or psychiatric services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Mindfulness-based Stress Reduction (MBSR) Programme for Parents of Children With ADHD: a Pilot Randomized Controlled Trial
The study aimed at comparing the effects of 8-week MBSR programme intervention group with usual care group in reducing parental stress and improving quality of life of parents of children with ADHD in Chinese culture.
Read the detailed description
This study aimed at comparing the effects of 8-week mindfulness-based stress reduction (MBSR) intervention with usual care in improving the parental stress, quality of life, and the feasibility and acceptability of MBSR of parents of children with Attention Deficit Hyperactivity Disorder (ADHD) in Chinese context after the coronavirus disease pandemic.
This study was designed as a pilot randomised controlled trial with single-blind repeated measures. By using convenience sampling, 36 parents of children with ADHD were recruited from the Parent Resource Centre of The Salvation Army (Centre), a Non-government Organization in Hong Kong, between July to August 2022. Centre staff invited parents of children aged 3-12 diagnosed with ADHD who can communicate and understand Cantonese to participate. Parents who had physical or severe intellectual disabilities, mental disorders or received any form of psychological intervention or psychiatric services were excluded from this study. All eligible parents were randomized to either the intervention group (n=18) or the usual care group (control) (n=18).
Parents assigned to the intervention group received the MBSR programme and usual services from the Centre. MBSR had eight weekly sessions of 2.5 hours each, plus a whole day retreat in small groups between session 6 and 7. The usual care group remained with usual support from the Centre, with interest activities such as cooking classes or calligraphy classes, but without any other form of intervention during this period.
- Conditions
- Stress, Psychological
- Being tested
- Mindfulness-based Stress Reduction
- Keywords
- Mindfulness-based stress reduction, parental stress, Attention-Deficit Hyperactivity Disorder ADHD, parent
- Medical subject headings
- Stress, Psychological, 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 Stress ReductionBehavioural
An 8-week Mindfulness-based stress reduction training programme
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 8-week mindfulness-based stress reduction training Receives: Behavioral: Mindfulness-based Stress Reduction |
| Placebo | No intervention | received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report of parental stress
self-report of parental stress as measured by Parental Stress Scale (score range from 1-90. The higher the score, the higher the stress level)
Measured: immediate after intervention
self-report perceived stress
self-report perceived stress as measured by Perceived Stress Scale (score range from 0-56. The higher the score, the higher the stress level)
Measured: immediate after intervention
Secondary outcomes (3)
self-report mindfulness in parenting
Parental self-reports of adopting mindful parenting strategies as measured by Interpersonal mindfulness in Parenting (Score range from 1-155. The higher score means adopted more mindful in parenting)
Measured: At one month after intervention
Parent reports of children's ADHD behaviors in the past 6 months
parent reports of children's ADHD symptoms by using the Strengths and Weakness of ADHD symptoms and normal behavior rating scales (score range from +3 far below average to -3 far above average)
Measured: At one month after intervention
self-report quality of life
self-report to access perception of quality of life in four domains including physical, psychological, social relationships and general health (score range from 0 - 100. A higher score indicated a better quality of life)
Measured: At one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jun 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
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 Stress, PsychologicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MBSR intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Responsible party
- Principal investigator, Yim Wah MAK, Ph.D, The Hong Kong Polytechnic University
- Investigators
- Yim Wah MAK, Ph.D, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210113
- Sponsor's protocol ID
- HSEARS S20211015010
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Law TY, Bressington D, Ruan J, Wong WK, Mak YW. The effectiveness of a mindfulness-based stress reduction (MBSR) programme for parents of children with attention deficit hyperactivity disorder (ADHD): a pilot randomized controlled trial. BMC Psychol. 2025 Apr 24;13(1):429. doi: 10.1186/s40359-025-02747-4.
PubMed 40275428
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mindfulness-based Stress Reduction (MBSR) Programme for Parents of Children With ADHD: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06210113
- Acronym / sponsor ID
- HSEARS S20211015010
- Conditions
- Stress, Psychological
- Keywords
- Mindfulness-based stress reduction, parental stress, Attention-Deficit Hyperactivity Disorder ADHD, parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 18 Jan 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.
The study aimed at comparing the effects of 8-week MBSR programme intervention group with usual care group in reducing parental stress and improving quality of life of parents of children with ADHD in Chinese culture.
Detailed description
This study aimed at comparing the effects of 8-week mindfulness-based stress reduction (MBSR) intervention with usual care in improving the parental stress, quality of life, and the feasibility and acceptability of MBSR of parents of children with Attention Deficit Hyperactivity Disorder (ADHD) in Chinese context after the coronavirus disease pandemic.
This study was designed as a pilot randomised controlled trial with single-blind repeated measures. By using convenience sampling, 36 parents of children with ADHD were recruited from the Parent Resource Centre of The Salvation Army (Centre), a Non-government Organization in Hong Kong, between July to August 2022. Centre staff invited parents of children aged 3-12 diagnosed with ADHD who can communicate and understand Cantonese to participate. Parents who had physical or severe intellectual disabilities, mental disorders or received any form of psychological intervention or psychiatric services were excluded from this study. All eligible parents were randomized to either the intervention group (n=18) or the usual care group (control) (n=18).
Parents assigned to the intervention group received the MBSR programme and usual services from the Centre. MBSR had eight weekly sessions of 2.5 hours each, plus a whole day retreat in small groups between session 6 and 7. The usual care group remained with usual support from the Centre, with interest activities such as cooking classes or calligraphy classes, but without any other form of intervention during this period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- MBSR intervention
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness-based Stress Reduction8-week mindfulness-based stress reduction training |
| Placebo | No intervention | –received usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- parents who have a child aged 3-12 with a confirmed diagnosis of ADHD with or without medications
- able to communicate and understand Cantonese
Key exclusion criteria (3 listed)
- having physical disabilities or severe intellectual impairments
- any forms of mental disorders
- receiving any other form of psychological intervention, behavioural treatment, or psychiatric services
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 Stress ReductionAn 8-week Mindfulness-based stress reduction training programme | Behavioural | Mindfulness |
Primary outcome
Self-report of parental stress
Time frame: immediate after intervention
self-report of parental stress as measured by Parental Stress Scale (score range from 1-90. The higher the score, the higher the stress level)
self-report perceived stress
Time frame: immediate after intervention
self-report perceived stress as measured by Perceived Stress Scale (score range from 0-56. The higher the score, the higher the stress level)
3 secondary outcomes
self-report mindfulness in parenting
Time frame: At one month after intervention
Parent reports of children's ADHD behaviors in the past 6 months
Time frame: At one month after intervention
self-report quality of life
Time frame: At one month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40275428Law TY, Bressington D, Ruan J, Wong WK, Mak YW. The effectiveness of a mindfulness-based stress reduction (MBSR) programme for parents of children with attention deficit hyperactivity disorder (ADHD): a pilot randomized controlled trial. BMC Psychol. 2025 Apr 24;13(1):429. doi: 10.1186/s40359-025-02747-4.
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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. This study is not recruiting at the moment.
Yim Wah MAK, Ph.D principal investigator
School of Nursing, 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 Stress Reduction in people with Stress, Psychological, 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 2 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of parental stress (time frame: immediate after intervention). The study lists 2 primary outcomes in all. 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 NCT06210113, 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 28 Feb 2024.