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

NCT ID: NCT04427683

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Brief mindful parenting program

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Brief mindful parenting program

Intervention Type BEHAVIORAL

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.

Interventions

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Brief mindful parenting program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman, Hay-ming LO, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

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LO, Herman Hay-ming

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Lo HHM, Lau ENS, Tam CHL, Ngai SW, Chan SHW, Leung BFH, Wong ET, Wong EWY, Wong GOC, Cho WC, Tsang AWK, Singh NN. Effects of a Mindful Parenting Workshop for Parents of Adolescents and Young Adults Following Social Unrest in Hong Kong. Mindfulness (N Y). 2022;13(1):248-261. doi: 10.1007/s12671-021-01790-7. Epub 2021 Dec 2.

Reference Type DERIVED
PMID: 34873419 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SR2020.A6.004

Identifier Type: -

Identifier Source: org_study_id

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