- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07083661
- Original Trial
Mindfulness-based Intervention and Young Children's Screen Time
Mindfulness-based Intervention on Parent Empowerment in Reducing Young Children's Screen Time (MORE): a Mixed Method Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuen Ling Leung, Doctor of Nursing
- Phone Number: 39708751
- Email: lleung@hkmu.edu.hk
Study Contact Backup
- Name: Sze Him, Isaac Leung, PhD in Statistics
- Phone Number: 3943 9423
- Email: shleung@cuhk.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- parent-child dyads resident in Hong Kong;
- child being between 2 and 6- year; and
- child with normal intellectual ability.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-based intervention on parent empowerment in reducing children's screen time (MORE)
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.
|
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.
|
|
No Intervention: Waistlist control group
Participants will be required to maintain their usual daily activities without begin any mindfulness and skills programme for 6-week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screen time exposure - frequency
Time Frame: Baseline, week 6, week 18
|
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
Time Frame: Baseline, week 6, week 18
|
Duration will be record in terms of minutes
|
Baseline, week 6, week 18
|
|
Screen time exposure - nature and content
Time Frame: Baseline, week 6, week 18
|
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
Time Frame: Baseline, week 6, week 18
|
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
Time Frame: Baseline, week 6, week 18
|
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
Time Frame: Baseline, week 6, week 18
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in children disruptive behavior
Time Frame: Baseline, week 6, week 18
|
The Eyberg Child Behaviour Inventory is a 36-item questionnaire that consists of two subscales: the intensity scale and the problem scale.
The intensity scale assesses the common child behavior problems frequency from 1 to 7 (1 = "never", 7 = "always"), and the problem scale assesses the extent to which the parents find the troublesome behavior in "yes" or "no".
The lowest score is 36, and the highest score is 252.
Higher scores indicate more child behavior problems.
|
Baseline, week 6, week 18
|
|
Change in parent-child relationships
Time Frame: Baseline, week 6, week 18
|
The Parenting Sense of Competence Scale is a 6-point Likert scale with 15-item.
Each item is scored from 1 to 6 (1 = "strongly disagree", 6 = "strongly agree"), the lowest score is 15, and the highest score is 90.
A higher score represents a better parent-child relationship
|
Baseline, week 6, week 18
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the study - recruitment and retention rate
Time Frame: week 6, week 18
|
Recruitment and retention rates will be recorded as a percentage.
|
week 6, week 18
|
|
Feasibility of the study - attendance rates
Time Frame: week 6, week 18
|
Attendance rates are defined as the number of training sessions a subject has attended.
|
week 6, week 18
|
|
Feasibility of the study - time required to recruit to target sample size
Time Frame: week 6, week 18
|
The time required to recruit to target sample size will be record in terms of week
|
week 6, week 18
|
|
Feasibility of the study - adverse events
Time Frame: week 6, week 18
|
Adverse events will be recorded in terms of narrative style.
|
week 6, week 18
|
|
Acceptability of the study
Time Frame: week 6, week 18
|
Perception and satisfaction level of the intervention programme will be assessed by questionnaire
|
week 6, week 18
|
|
Comments and suggestions on intervention programme
Time Frame: week 6, week 18
|
A total of 10 parent-child dyads will be invited to an hour focus group interview after the completion of the MORE programme to gather the experiences of participants. A semi-structured interview question will be used for focus group discussions and individual interviews, and an audio recorder will be used to record the dialogue of the focus group interview. The audiotaped interviews will be transcribed verbatim by a trained RA. |
week 6, week 18
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuen Ling Leung, Doctor of Nursing, Hong Kong Metropolitan University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- RD/2025/1.7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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