mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
Primary Purpose
Postnatal Depression, Quality of Life, Family Relations
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
family-based mHealth Intervention
mother-only mHealth Intervention
Health education
Sponsored by
About this trial
This is an interventional supportive care trial for Postnatal Depression
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not able to understand written or spoken Chinese.
- Expectant mothers whose EPDS score is equal to or high than the cut-off score of 10.
- Not willing or not able to provide informed consent.
Sites / Locations
- Kwong Wah HospitalRecruiting
- Tsan Yuk HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
family-based mHealth intervention
mother-only mHealth intervention
Health education
Arm Description
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.
The expectant mothers in this group will receive health education and support via a smartphone app.
The expectant mothers in the control group will receive health education via a smartphone app.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
NCT ID
NCT05275413
First Posted
March 2, 2022
Last Updated
August 18, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Kwong Wah Hospital, The University of Hong Kong, University of Glasgow, Tsan Yuk Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05275413
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Kwong Wah Hospital, The University of Hong Kong, University of Glasgow, Tsan Yuk Hospital, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression, Quality of Life, Family Relations
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1578 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
family-based mHealth intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
mother-only mHealth intervention
Arm Type
Experimental
Arm Description
The expectant mothers in this group will receive health education and support via a smartphone app.
Arm Title
Health education
Arm Type
Active Comparator
Arm Description
The expectant mothers in the control group will receive health education via a smartphone app.
Intervention Type
Behavioral
Intervention Name(s)
family-based mHealth Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mother-only mHealth Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postnatal depression symptoms
Description
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).
Time Frame
24 weeks after start of intervention
Secondary Outcome Measure Information:
Title
Perceived social support levels of expectant mothers
Description
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).
Time Frame
24 weeks after start of intervention
Title
Anxiety and stress levels of all participants
Description
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).
Time Frame
24 weeks after start of intervention
Title
Health-related quality of life (QoL) of all participants
Description
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.
Time Frame
24 weeks after start of intervention
Title
Perceived family cohesion levels of all participants
Description
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.
Time Frame
24 weeks after start of intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Not able to understand written or spoken Chinese.
Expectant mothers whose EPDS score is equal to or high than the cut-off score of 10.
Not willing or not able to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Kin Ming LO, Phd
Phone
2766 5760
Email
camilla.lo@polyu.edu.hk
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wing Cheong Leung
Facility Name
Tsan Yuk Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Wang Cheung
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
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