NCT05480423

Brief Summary

This project apply curriculum of online programme materials and structure for mindful parenting and caregiving. It will include four modules (introductory mindfulness, mindful parenting, applying mindfulness in challenging moments, and advanced exercises for parents of children with special needs). Each module will include short psychoeducation videos and audio mindfulness exercises that can be used in various web-based or application-based platforms. A set of videos and audio exercises will be produced for the core program materials. One study of online mindful parenting program reported a low completion rate below 30%, showing the significance of weekly video or phone contact by professionals in program engagement. Although web-based or application-based mindfulness intervention have become popular, very limited effort has been developed for applying mindfulness in parenting and caregiving using technology. Only two published studies on online mindfulness-based intervention for parents are identified. Objectives of the study are: 1. Investigate the effects of online mindfulness-based intervention for parents of children with Attention Deficit/Hyperactivity Disorder. 2. Validate the protocol of the programme and explore the needs to make refinements of the programme based on the quantitative outcome and qualitative interview analyses

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

July 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

April 5, 2023

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 27, 2022

Last Update Submit

April 3, 2023

Conditions

Keywords

ADHDparentMindfulness-based interventionOnline

Outcome Measures

Primary Outcomes (1)

  • Parental stress

    The Parenting Stress Index Short Form (PSI-SF) will be used to measure parental stress (Abidin, 1995; Lam, 1999). A total of 36 items covers three dimensions parental distress, parent-child dysfunctional interaction, and difficult child. Parents will rate the items on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). Total score from 36 to 180. The higher the score, the higher the level of stress.

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

Secondary Outcomes (5)

  • Parent Anxiety

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

  • Parent depression

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

  • Family Functioning

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

  • Parent Quality of Sleep

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

  • Child Attention Deficit/Hyperactivity Disorder (ADHD) symptomology

    Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

Study Arms (2)

Online mindfulness-based intervention

EXPERIMENTAL

The online programme lasts for 28 days. Parents will receive the links of daily mini-lectures that introduced basic principles in mindfulness and mindful parenting, audio files of guided mindfulness practice, and exercises that facilitates parents to integrate mindfulness in their daily lives. The total time spent in each session will be around 15 to 20 minutes. Weekly meeting will be arranged with mindfulness instructor and participants.

Behavioral: Mindfulness-based intervention

Waitlist controlled group

NO INTERVENTION

Participants will be offered same intervention three months later

Interventions

1\. Psychoeducation video on mindfulness and mindful parenting. 2. Audio files of mindfulness exercises including mindfulness of breath, body scan, mindful stretching, mindfulness of soles of the feet, befriending exercises. 3. Informal mindfulness exercises by applying mindfulness in daily lives

Online mindfulness-based intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • parents whose children are between 6 and 18 years old and diagnosed with Attention Deficit/Hyperactivity Disorder
  • parents can understand and speak Cantonese Chinese, and
  • participants should be the primary caretaker of the children in the last one year

You may not qualify if:

  • parents who were diagnosed with psychosis, developmental disabilities, or cognitive impairment, which may present difficulties in comprehending the content of the program,
  • parents have had prior experience in any 8-week Mindfulness-Based Stress Reduction/Mindfulness-Based Cognitive Therapy or equivalent program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lo HHM, Lam J, Zhang ZJ, Cheung M, Chan SKC, Wong EWY, Bogels SM, Chui WH. Effects of an online mindfulness-based program for parents of children with attention deficit/hyperactivity disorder: a pilot, mixed methods study. Front Psychiatry. 2024 Apr 24;15:1376867. doi: 10.3389/fpsyt.2024.1376867. eCollection 2024.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Herman Hay Ming Lo, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2022

First Posted

July 29, 2022

Study Start

August 15, 2022

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

April 5, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations