Skip to main content
OpenTrials
Completed

NCT Number: NCT04427683

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LO, Herman Hay-ming

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief mindful parenting program

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.

Primary outcomes

  1. 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

  1. Anxiety

    Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

    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

  2. Post-traumatic stress

    Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

    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

  3. family functioning

    Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

    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

  4. family conflict

    Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

    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

  5. mindful parenting

    Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

    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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Acronym: MPHKC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.