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临床试验/NCT04427683
NCT04427683已完成不适用

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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •parents of adolescents at aged between 10 to 21
  • •a score of PHQ-9 of 2 or above

排除标准

  • •parents with self-reported psychosis, alcohol or substance abuse, individual or family crisis in last six months

研究组 & 干预措施

Brief mindful parenting program

Experimental

The program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care.

干预措施: Brief mindful parenting program (Behavioral)

Wait-list control group

Other

A four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention.

干预措施: Brief mindful parenting program (Behavioral)

结局指标

主要结局

Depression

时间窗: 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

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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