Clinical trial NCT05275413: mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
Official title: Engaging the Whole Family to Support Expectant Mothers: A Family-based mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Quality of Life
Family Relations
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
name: The University of Hong Kong
name: University of Glasgow
name: Tsan Yuk Hospital, Hong Kong
First posted: 2022-03-11
Enrollment: 1578
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Possession of a smartphone and a personal email address for receiving and sending information relevant to the study.
3. Willing to accept the study arrangements.

Exclusion Criteria:

1. Not able to understand written or spoken Chinese.
2. Expectant mothers whose EPDS score is equal to or high than the cut-off score of 10.
3. Not willing or not able to provide informed consent.

Primary outcomes:
measure: Postnatal depression symptoms
timeFrame: 24 weeks after start of intervention
Secondary outcomes:
measure: Perceived social support levels of expectant mothers
timeFrame: 24 weeks after start of intervention
measure: Anxiety and stress levels of all participants
timeFrame: 24 weeks after start of intervention
measure: Health-related quality of life (QoL) of all participants
timeFrame: 24 weeks after start of intervention
measure: Perceived family cohesion levels of all participants
timeFrame: 24 weeks after start of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Tsan Yuk Hospital
Study officials:
References: