Clinical trial NCT04427683: Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest
Official title: Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: parent depression
parent mental health
mindfulness-based intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depression
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Secondary outcomes:
measure: Anxiety
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
measure: Post-traumatic stress
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
measure: family functioning
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
measure: family conflict
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
measure: mindful parenting
timeFrame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LO, Herman Hay-ming
Study officials:
affiliation: Hong Kong Polytechnic University
name: Herman, Hay-ming LO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo HHM, Lau ENS, Tam CHL, Ngai SW, Chan SHW, Leung BFH, Wong ET, Wong EWY, Wong GOC, Cho WC, Tsang AWK, Singh NN. Effects of a Mindful Parenting Workshop for Parents of Adolescents and Young Adults Following Social Unrest in Hong Kong. Mindfulness (N Y). 2022;13(1):248-261. doi: 10.1007/s12671-021-01790-7. Epub 2021 Dec 2.