- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413538
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
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
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 Contact
- Name: Lun Wai Doris Lam
- Phone Number: (852)67706313
- Email: 1007627212@link.cuhk.edu.hk
Study Contact Backup
- Name: Winnie Wing-Sze Mak, Phd
- Phone Number: (852)3943-6577
Study Locations
-
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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
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)
July 1, 2022
Primary Completion (Anticipated)
September 28, 2022
Study Completion (Anticipated)
September 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)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 12, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Taichung Veterans General HospitalUnknown
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
Clinical Trials on Mindfulness training
-
University of California, San DiegoCompleted
-
Yale UniversityCompletedMental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) | Mental Health Wellness 1 | War-Related TraumaJordan
-
King's College LondonNot yet recruitingAdults With Overweight and Obesity
-
University of HoustonCompletedDepression | Stress | Anxiety | Well-beingUnited States
-
The Miriam HospitalCompleted
-
Boston University Charles River CampusTerminatedSmoking CessationUnited States
-
Freie Universität BerlinCharite University, Berlin, GermanyCompletedMajor Depressive Disorder
-
University of South FloridaNational Institute of Nursing Research (NINR)RecruitingQuality of Life | Type 1 Diabetes | AnxietyUnited States
-
Chinese University of Hong KongCompletedStress | Parenting | ParentsHong Kong