Skip to main content
Clinical Trials/NCT04427683
NCT04427683
Completed
N/A

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

The Hong Kong Polytechnic University1 site in 1 country100 target enrollmentMay 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
The Hong Kong Polytechnic University
Enrollment
100
Locations
1
Primary Endpoint
Depression
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Post-traumatic stress(Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).)
  • mindful parenting(Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).)
  • family functioning(Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).)
  • family conflict(Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).)
  • Anxiety(Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).)

Study Sites (1)

Loading locations...

Similar Trials