Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest (MPHKC)

April 12, 2021 updated by: The Hong Kong Polytechnic University

Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial

A four session mindful parenting workshop is designed to promote parental mental health during the social unrest in 2020. This study is conducted to investigate the outcome of the program. It is a randomised control trial design and will be conducted in five sites in Hong Kong. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The primary outcome is parental depression. Secondary outcomes include parental anxiety and post-traumatic stress, negative emotions, family functioning, family conflict and mindful parenting. Exposure to social unrest will be measured and the relationship to mental health and effects of the program will be examined.

Study Overview

Status

Completed

Conditions

Detailed Description

Design: With a self-administered screening for depression (PHQ-9), parents with a subclinical cutoff score or above will be eligible to participate in a four-session parent workshop. The same program will be provided in five locations in Hong Kong. A waitlist-control randomised controlled trial will be used to evaluate the outcomes of the program. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The sample estimation is based on an expected effect size of .33 for family functioning in the PI's pilot study, with an estimated drop-out rate of 15%, a two-tailed α error of 5%, 80% power, and a test of two independent groups.

Measures: (1) Exposure to social unrest will be measured using the Political Life Events Scale. The scale contains 20 items related to stressful events, to which respondents report exposure by answering yes or no. In view of the local context, only 16 items will be used. (2) Negative emotions about social unrest will be measured by the three items developed by Halperin et al. The items assess the intensity of negative emotions (hatred, anger, despair) in the context of social unrest, with responses given on a Likert-type scale ranging from 1 (not at all) to 10 (very strong). (3) Depression and anxiety symptoms will be assessed by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) scale. (4) Traumatic stress will be assessed by the International Trauma Questionnaire (ITQ), a 6-item self-report measure of the major symptoms of post-traumatic stress. The ITQ has been translated into Chinese and validated for screening of post-traumatic stress. (5) Family functioning will be assessed by the Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR). The 5-item scales uses a 3-point response scale (0 = hardly ever and 2 = almost always). A cutoff for severe family dysfunction is available for Chinese families. (6) Family conflict will be measured by the Conflict Tactics Scale (CTS-2), a self-report measure of behavioural assault or psychological aggression among family members. It has been used in studies of conflict between adolescents and parents.

Study Type

Interventional

Enrollment (Actual)

100

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

      • Hong Kong, Hong Kong
        • LO, Herman Hay-ming

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • parents of adolescents at aged between 10 to 21
  • a score of PHQ-9 of 2 or above

Exclusion Criteria:

  • parents with self-reported psychosis, alcohol or substance abuse, individual or family crisis in last six months

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: Brief mindful parenting program
The program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care.
Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.
Other: Wait-list control group
A four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention.
Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Self-administered measure Patient Health Questionnaire (PHQ-9), 9 items, sum of scores range from 0 to 27, the higher the score, the more severe in depressive symptoms
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Self-administered measure Generalized Anxiety Disorder 7-item scale (GAD-7), 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Post-traumatic stress
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
self-administered measure International Trauma Questionnaire (ITQ), 6 items, sum of scores range from 0 to 24, the higher the score, the more severe the post-traumatic stress symptoms
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family functioning
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
self-administered measure Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR), 5 items, sum of the scores range from 0 to 10, the higher the score, the better in family functioning
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family conflict
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
self-administered measure Conflict Tactics Scale (CTS-2), 16 items, sum of scores range from 0 to 112, the higher the score, the more stronger intensity the family conflict is
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
mindful parenting
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
self administered measure, Interpersonal Mindfulness in Parenting scale, 6 items in nonjudgmental acceptance in parenting and 4 items in listening with full attention, sum of scores range from 6 to 30 for nonjudgmental acceptance in parenting, and 6 to 20 for listening with full attention, the higher the score, the stronger the interpersonal mindfulness level is
Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Herman, Hay-ming LO, PhD, Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 15, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR2020.A6.004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The protocol will be published in an open access academic journal.

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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