NCT06210113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

December 20, 2023

Last Update Submit

February 27, 2024

Conditions

Keywords

Mindfulness-based stress reduction, parental stress, Attention-Deficit Hyperactivity Disorder ADHDparent

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    immediate after intervention

Secondary Outcomes (3)

  • self-report mindfulness in parenting

    At one month after intervention

  • Parent reports of children's ADHD behaviors in the past 6 months

    At one month after intervention

  • self-report quality of life

    At one month after intervention

Study Arms (2)

Mindfulness

EXPERIMENTAL

8-week mindfulness-based stress reduction training

Behavioral: Mindfulness-based Stress Reduction

Placebo

NO INTERVENTION

received usual care

Interventions

An 8-week Mindfulness-based stress reduction training programme

Mindfulness

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • parents who have a child aged 3-12 with a confirmed diagnosis of ADHD with or without medications
  • able to communicate and understand Cantonese

You may not qualify if:

  • having physical disabilities or severe intellectual impairments
  • any forms of mental disorders
  • receiving any other form of psychological intervention, behavioural treatment, or psychiatric services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Salvation Army - Hong Kong and Macau Command

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, PsychologicalAttention Deficit Disorder with Hyperactivity

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yim Wah MAK, Ph.D

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: MBSR intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 18, 2024

Study Start

June 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations