- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06210113
Training Parents of Children With ADHD by Mindfulness-based Stress Reduction for Reducing Stress
The Effectiveness of Mindfulness-based Stress Reduction (MBSR) Programme for Parents of Children With ADHD: a Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Salvation Army - Hong Kong and Macau Command
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parents who have a child aged 3-12 with a confirmed diagnosis of ADHD with or without medications
- able to communicate and understand Cantonese
Exclusion Criteria:
- having physical disabilities or severe intellectual impairments
- any forms of mental disorders
- receiving any other form of psychological intervention, behavioural treatment, or psychiatric services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness
8-week mindfulness-based stress reduction training
|
An 8-week Mindfulness-based stress reduction training programme
|
|
No Intervention: Placebo
received usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
immediate after intervention
|
|
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)
|
immediate after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-report mindfulness in parenting
Time Frame: At one month after intervention
|
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)
|
At one month after intervention
|
|
Parent reports of children's ADHD behaviors in the past 6 months
Time Frame: At one month after intervention
|
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)
|
At one month after intervention
|
|
self-report quality of life
Time Frame: At one month after intervention
|
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)
|
At one month after intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yim Wah MAK, Ph.D, School of Nursing, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS S20211015010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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