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临床试验/NCT05275413
NCT05275413Unknown不适用

Engaging the Whole Family to Support Expectant Mothers: A Family-based mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 1,578 人开始时间: 2022年6月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,578
试验地点
2
主要终点
Postnatal depression symptoms

研究概览

简要总结

The proposed study is to test the effectiveness of a culturally-attuned, family-based mobile health (mHealth) intervention in reducing symptoms of postnatal depression and promoting health among expectant mothers in Hong Kong. Using a family perspective, the proposed mHealth intervention will engage family members, including expectant fathers and grandparents, in providing support to expectant mothers. Expectant mothers and their family members will be recruited at antenatal clinics at two public hospitals in Hong Kong and randomized to receive the family-based mHealth intervention (experimental), the mother-only mHealth intervention (experimental), or the health education (control). Maternal depression, anxiety and stress, perceived social support, health-related quality of life, and perceived family cohesion will be assessed at recruitment and four weeks after childbirth. For family members, symptoms of anxiety and stress, health-related quality of life, and perceived family cohesion will be measured.

详细描述

Postnatal depression is a prevalent health issue affecting women. Although empirical evidence has proven the effectiveness of face-to-face antenatal classes in reducing perinatal distress, the availability of such support is often limited and is insufficient to benefit all parents who need it. Another challenge in pregnancy support is the difficulty to engage family members in providing support to expectant mothers. To address these limitations, the proposed project aims to develop and test the effectiveness of a family-based mobile health (mHealth) intervention, which will engage family members, including expectant fathers and grandparents to provide support to expectant mothers.

Specifically, the family-based mHealth intervention consists of a smartphone app with different versions designed for expectant mothers, fathers, and grandparents. The smartphone app will provide a user-friendly platform for users to receive psychoeducation materials related to pregnancy (e.g. antenatal care, postnatal care, and infant care) and an interactive forum for all users to ask questions related to pregnancy and family communication, which will be answered by health and social care professionals. To enhance family's engagement, we will also include other functions in the app to encourage communications among family members and enhance family cohesion. These functions include a platform for family members to send texts and share photos, and a shared schedule with alerts for dates related to pregnancy (e.g. appointments for antenatal check-ups and expected delivery date).

Using a randomized controlled design, the proposed study will evaluate the effectiveness of the family-based mHealth intervention in reducing maternal postnatal depression and promoting health in expectant mothers and their family members (expectant fathers and grandparents). The study will recruit 1,578 expectant mothers and their family members at the antenatal clinics at two selected public hospitals in Hong Kong. The participants will be randomized into three groups (i) family-based mHealth intervention; (ii) mother-only mHealth intervention; and (iii) health information control. Participants will be asked to complete a survey with question items related to their physical and mental health, perceived social support and family cohesion, at recruitment and four weeks after childbirth.

It is hypothesized that the family-based mHealth intervention is more effective in reducing symptoms of postnatal depression, promoting health of expectant mothers and their family members, and promoting family cohesion than the mother-only mHealth intervention and the control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Expectant mothers (18 years old or above) attending the antenatal clinics at two public hospitals, Kwong Wah Hospital and Tsan Yuk Hospital in Hong Kong and their family members.
  • Possession of a smartphone and a personal email address for receiving and sending information relevant to the study.
  • Willing to accept the study arrangements.

排除标准

  • Not able to understand written or spoken Chinese.
  • Expectant mothers whose EPDS score is equal to or high than the cut-off score of
  • Not willing or not able to provide informed consent.

结局指标

主要结局

Postnatal depression symptoms

时间窗: 24 weeks after start of intervention

Symptoms of maternal depression at four weeks postpartum will be assessed with the validated Chinese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS).

次要结局

  • Perceived social support levels of expectant mothers(24 weeks after start of intervention)
  • Anxiety and stress levels of all participants(24 weeks after start of intervention)
  • Health-related quality of life (QoL) of all participants(24 weeks after start of intervention)
  • Perceived family cohesion levels of all participants(24 weeks after start of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Camilla Lo

Assistant Professor

The Hong Kong Polytechnic University

研究点 (2)

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