Quality of Life Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 1578 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kwong Wah Hospital | Hong Kong | |
Hong Kong | Tsan Yuk Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | Kwong Wah Hospital, The University of Hong Kong, Tsan Yuk Hospital, Hong Kong, University of Glasgow |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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