mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Family Relations; Postnatal Depression
• Intervention / Treatment: Behavioral: family-based mHealth Intervention; Behavioral: mother-only mHealth Intervention; Other: Health education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1578
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Kin Ming LO, Phd; Phone Number: 2766 5760; Email: camilla.lo@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Kwong Wah Hospital
    • Contact: Wing Cheong Leung
  • Hong Kong, Hong Kong
    • Recruiting
    • Tsan Yuk Hospital
    • Contact: Ka Wang Cheung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: family-based mHealth intervention; The expectant mothers and their family members (fathers and grandparents) in this group will receive health education and support and family support via a smartphone app.	Behavioral: family-based mHealth Intervention; The intervention consists of three versions: mother, father, and grandparent. The app consists of health information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos. Each versions have their unique features, such as a platform to ask questions in mother version, a quiz game to promote fathers' knowledge related to father's involvement, educational materials tailored for grandparents. An obstetrician and a social worker will respond to the questions. Details please refer to the proposal.
EXPERIMENTAL: mother-only mHealth intervention; The expectant mothers in this group will receive health education and support via a smartphone app.	Behavioral: mother-only mHealth Intervention; The expectant mothers in this group will receive information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos via a smartphone app. The expectant mothers will also have access to a platform in the smartphone app to ask questions about their pregnancy. An obstetrician will respond to the questions.
ACTIVE_COMPARATOR: Health education; The expectant mothers in the control group will receive health education via a smartphone app.	Other: Health education; The expectant mothers in the control group will receive information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos via a smartphone app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postnatal depression symptoms	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).	24 weeks after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived social support levels of expectant mothers	Perceived social support levels of expectant mothers will be assessed with the Chinese version of the 12-item Multidimensional Scale of Perceived Social Support (MSPSS).	24 weeks after start of intervention
Anxiety and stress levels of all participants	Anxiety and stress levels of all participants (including the expectant mothers, fathers, and grandparents) will be assessed with the Anxiety and Stress subscales of the Chinese version of the Depression Anxiety Stress Scale (DASS21).	24 weeks after start of intervention
Health-related quality of life (QoL) of all participants	Health-related quality of life (QoL) of all participants will be measured with the validated Chinese version of the Short-form-12 Health survey (SF-12 v2), which consists of 12 items to be computed as two composite scores: physical component score and mental component score.	24 weeks after start of intervention
Perceived family cohesion levels of all participants	Perceived family cohesion levels of all participants will be assessed using the nine-item Family Cohesion subscale of the Chinese version of the Family Environment Scale.	24 weeks after start of intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong; Kwong Wah Hospital; University of Glasgow; Tsan Yuk Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (ACTUAL): March 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: KC/KE-20-0119/ER-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No