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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04427683
Study type Interventional
Source The Hong Kong Polytechnic University
Contact
Status Completed
Phase N/A
Start date May 15, 2020
Completion date September 30, 2020

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