- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413577
Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial
November 18, 2022 updated by: Lam Lun Wai Doris, Chinese University of Hong Kong
This research investigated the effects of mindfulness practice on mental wellbeing and parenting behaviour, with the instruction recordings delivered via existing instant messaging applications, including Whatsapp and Signal.
The two-week mindfulness program targeted parents with children in Nursery, Kindergarten to Primary School.
Due to the suspension of schools, work from home policies, parents spend increased amount of time with their children.
News reports have indicated that with the mounting care taking responsibilities and downturn of economy amidst the epidemic, parents have been experiencing higher stress that may negatively impact their wellbeing and parent-child relationship.
This study delivered an app-based intervention that aims at enhancing mindful parenting at the time of corona, where social distancing is emphasized.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
491
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shatin, Hong Kong
- Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Parents with at least one child who is in Primary School or below.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
The experimental group was invited to listen to a 15-minute mindfulness instructional recording delivered daily through an instant messaging application and to practice accordingly for 14 consecutive days at their own choice of time and place.
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The intervention recordings taught the basic concepts of mindfulness through simple guided meditations with content supported by science.
Each recording had the same format that included (1) a daily theme, (2) a meditation exercise echoing the theme, (3) a suggested exercise for practice, and (4) an invitation for participants to give a short response to their meditation experience at the end of the recording.
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No Intervention: Waitlist control group
The waitlist control group was only be required to complete the demographic information, pre, post experiment and follow-up questionnaires before they receive the mindfulness training intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Parental Stress Scale
Time Frame: Change from Baseline Parental Stress Scale at immediately after the intervention and two weeks after intervention
|
The Parental Stress Scale was used to measure self-perceived stress specific to the parenting role.
Parental Stress Scale was originally developed by Berry and Jones (1995) to measure parental feelings and experiences in terms of rewards, satisfaction, controllability, and stress.
The minimum score was 0 and the maximum score was 64.
A score of 0 represents lowest level of parental stress possible, whereas a score of 64 represents highest level of parental stress.
Higher scores indicate worse outcome.
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Change from Baseline Parental Stress Scale at immediately after the intervention and two weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Well-being WHO 5-item index
Time Frame: Change from Baseline Well-being WHO 5-item index at immediately after the intervention and two weeks after intervention
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Global mental well-being was measured using the Well-being WHO 5-item index (Topp et al., 2015).The minimum score was 0 and the maximum score was 25.
A score of 0 represents worst possible, whereas a score of 25 represents best possible quality of life.
Higher scores indicate better outcome.
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Change from Baseline Well-being WHO 5-item index at immediately after the intervention and two weeks after intervention
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Mindfulness in Parenting Scale
Time Frame: Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
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The 31-item Interpersonal Mindfulness in Parenting scale was adopted to measure parents' self-reported engagement in mindful parenting (Duncan, 2007).
The minimum score was 0 and the maximum score was 155.
A score of 0 represents lowest level of parental mindfulness, whereas a score of 155 represents highest level of parental mindfulness possible.
Higher scores indicate better outcome.
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Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
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Parent Behavior Inventory
Time Frame: Change from Baseline Parent Behavior Inventory at immediately after the intervention and two weeks after intervention
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The Parent Behavior Inventory was used to assess the change in parenting behavior before and after the intervention.
The Parent Behavior Inventory has two independent scales, supportive/engaged and hostile/coercive parenting (Lovejoy et al., 1999), The minimum score was 0 and the maximum score for each scale was 50.
A score of 0 represents lowest frequency of parenting behaviors on supportive/engaged and hostile/coercive parenting, whereas a score of 50 represents highest frequency of supportive/engaged and hostile/coercive parenting possible.
Higher scores of supportive/engaged scale indicate better outcome.
Lower scores of hostile/coercive scale indicate better outcome.
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Change from Baseline Parent Behavior Inventory at immediately after the intervention and two weeks after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lun Wai Doris Lam, M.S.Sc, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
June 4, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 18, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBRE-20-562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No identifiable personal information was collected.
Surveys were be anonymized to protect the privacy of research participants.
All information obtained in the course of this experiment will be used for research purposes only; it will be protected and kept confidential by the researchers of this project and not be shared with a third party unless forced by law.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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