Effects of a Mindfulness-Based Intervention Delivered Via Instant Messaging on Parents' Wellbeing: A Randomized Controlled Trial and Investigation of Moderators

June 12, 2022 updated by: Lam Lun Wai Doris, Chinese University of Hong Kong
This research investigates the effects of mindfulness practice on mental wellbeing with the instruction recordings delivered via existing instant messaging applications, Whatsapp. The two-week mindfulness program targets parents with children in Secondary School or below. This research also explores how parenting and attachment styles moderate the intervention effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Winnie Wing-Sze Mak, Phd
  • Phone Number: (852)3943-6577

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Chinese University of Hong Kong
        • Contact:
          • Winnie Wing-Sze Mak, Phd
          • Phone Number: (852)3943-6577

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 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 Secondary 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
The experimental group will be 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.
Behavioral: Mindfulness training
The intervention recordings will teach the basic concepts of mindfulness through simple guided meditations with content supported by science. Each recording has 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.
No Intervention: Waitlist control group
The waitlist control group will only be required to complete the demographic information, pre, post experiment and follow-up questionnaires before they receive the mindfulness training intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Parental Stress Scale at immediately after the intervention and two weeks after intervention
Interpersonal Mindfulness in Parenting Scale
Time Frame: Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
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.
Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
Non-attachment to Self Scale
Time Frame: Change from Baseline Non-attachment to Self Scale at immediately after the intervention and two weeks after intervention
Non-attachment to Self Scale measures the absence of fixation on self-related concepts, thoughts and feelings, and a capacity to flexibly interact with these concepts, thoughts and feelings without trying to control them (Whitehead et al., 2018). The minimum score was 0 and the maximum was 49. The higher the score the more nonattached the participant. Higher scores indicate better outcome.
Change from Baseline Non-attachment to Self Scale at immediately after the intervention and two weeks after intervention
Nonattachment Scale - Short Form
Time Frame: Change from Baseline Nonattachment Scale - Short Form at immediately after the intervention and two weeks after intervention
Nonattachment Scale measures an individual's release from mental fixations in a flexible, balanced way of relating to one's experiences without clinging to or suppressing them (Chio, Lai, & Mak, 2018). The minimum score was 0 and the maximum was 48. The higher the score the more nonattached the participant. Higher scores indicate better outcome.
Change from Baseline Nonattachment Scale - Short Form at immediately after the intervention and two weeks after intervention
Peace of mind
Time Frame: Change from Baseline Peace of mind Scale - Short Form at immediately after the intervention and two weeks after intervention
Peace of mind scale measures an individual's internal state of peacefulness and harmony (Lee et al., 2013).The minimum score was 0 and the maximum score was 35. Higher scores reflect higher levels of peace of mind. Higher scores indicate better outcome.
Change from Baseline Peace of mind Scale - Short Form at immediately after the intervention and two weeks after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Experiences in Close Relationship Scale-Short Form
Time Frame: Change from Baseline The Experiences in Close Relationship Scale - Short Form at immediately after the intervention and two weeks after intervention
The Experience in Close Relationship Scale is a 12 item self-report adult attachment style questionnaire focused on close relationships (Brennan, Clark & Shaver, 1998). It provides data on two continuous scales concerning the extent to which participants show attachment dimensions: anxiety and avoidance. The scale consists of 12 items which participants respond to on a seven-point scale. The minimum score was 0 and the maximum score for each scale was 72. The lower the score the more securely attached the participant. Higher scores indicate worse outcome.
Change from Baseline The Experiences in Close Relationship Scale - Short Form at immediately after the intervention and two weeks after intervention
Training Scale
Time Frame: Change from Baseline Training Scale at immediately after the intervention and two weeks after intervention
The Training Scale measures child-rearing items specific to the Chinese culture (Chao, 1994). The training scale covered two areas, "ideologies on child development and learning" (involving seven items) and "ideologies on the mother-child relationship" (involving six items). The minimum score was 0 and the maximum score was 65. The higher the score the more the participant pertains to chiao shun, or training.
Change from Baseline Training Scale at immediately after the intervention and two weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBRE(R)-21-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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