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

Mental Health Issue Clinical Trial

— MPHKC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427683
• Other study ID #: SR2020.A6.004
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2020
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue
• Tooth, Impacted

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hong Kong	LO, Herman Hay-ming	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	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	Anxiety	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).
Secondary	Post-traumatic stress	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).
Secondary	family functioning	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).
Secondary	family conflict	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).
Secondary	mindful parenting	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).