NCT07083661

Brief Summary

This research proposal aims to explore the effectiveness of the mindfulness-based intervention (MBI) on reducing young children's screen time (ST) and caring parents' psychological and social issues in Hong Kong.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Aug 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

July 4, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 4, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

screen time exposure

Outcome Measures

Primary Outcomes (6)

  • Screen time exposure - frequency

    Children's screen time exposure including frequency will be record in terms of times per week

    Baseline, week 6, week 18

  • Screen time exposure - duration

    Duration will be record in terms of minutes

    Baseline, week 6, week 18

  • Screen time exposure - nature and content

    Screen time exposure, nature, and content require the parent to provide the types and names of the shows watched by their young children.

    Baseline, week 6, week 18

  • Screen time exposure - viewing behavior

    The parents are required to provide the information on young children's viewing behavior, including singing, role play, discussing issues or discussing the films and shows by selecting from the questionnaire.

    Baseline, week 6, week 18

  • Change in parental stress level

    The Parenting Stress Index - short form. It is a 36-item 5-point Likert scale with three 12-item subscales. Each item is scored from 1 to 5 (1 = "strongly disagree", 5 = "strongly agree"). The lowest score is 36, and the highest score is 180. Higher scores indicated higher parenting stress, and the cutoff point is \>90.

    Baseline, week 6, week 18

  • Change in social support adquency level

    The Multidimensional Scale of Perceived Social Support Questionnaire is a 12-item questionnaire. Each item is scored from 1 to 7 (1 = "strongly disagree", 7 = "strongly agree"), the lowest score is 12 and the highest score is 84. A higher score defines higher social support from family, friends and significant others.

    Baseline, week 6, week 18

Secondary Outcomes (2)

  • Change in children disruptive behavior

    Baseline, week 6, week 18

  • Change in parent-child relationships

    Baseline, week 6, week 18

Other Outcomes (6)

  • Feasibility of the study - recruitment and retention rate

    week 6, week 18

  • Feasibility of the study - attendance rates

    week 6, week 18

  • Feasibility of the study - time required to recruit to target sample size

    week 6, week 18

  • +3 more other outcomes

Study Arms (2)

Mindfulness-based intervention on parent empowerment in reducing children's screen time (MORE)

EXPERIMENTAL

The intervention consists of 6-session mindfulness-based intervention. Each session last for 2 hours. The training will be led by an experience certified mindfulness teacher.

Behavioral: Mindfulness-based intervention on parent empowerment in reducing children's screen time (MORE)

Waistlist control group

NO INTERVENTION

Participants will be required to maintain their usual daily activities without begin any mindfulness and skills programme for 6-week

Interventions

Participants will receive a 6-week MORE group training by integration of mindfulness-based component into a modified Hands-on Parent Empowerment-20 (HOPE-20) programme.

Mindfulness-based intervention on parent empowerment in reducing children's screen time (MORE)

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • parent-child dyads resident in Hong Kong;
  • child being between 2 and 6- year; and
  • child with normal intellectual ability.

You may not qualify if:

  • children with major developmental problems, history of domestic violence, drug abuse, or mental illness in the family;
  • being unable to communicate and understand Cantonese as the intervention will be conducted in Cantonese; and
  • parent-child dyads previous participation in mindfulness-based training for less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yuen Ling Leung, Doctor of Nursing

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen Ling Leung, Doctor of Nursing

CONTACT

Sze Him, Isaac Leung, PhD in Statistics

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 24, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share