- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427683
Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest (MPHKC)
Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- LO, Herman Hay-ming
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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.
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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.
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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.
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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).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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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).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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Post-traumatic stress
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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family functioning
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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family conflict
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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mindful parenting
Time Frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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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
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Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
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Collaborators and Investigators
Investigators
- Principal Investigator: Herman, Hay-ming LO, PhD, Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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