Expectant Couples Clinical Trial
Official title:
"Becoming Parents": A Hospital-community Partnership to Enhance Transition to Parenthood
| Verified date | December 2013 |
| Source | The University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hong Kong: Ethics Committee |
| Study type | Interventional |
The proposed of this study is to determine if an intervention, known as the "Becoming Parents" programme, is more effective in improving the mental health, marital relationship and parental competence of expectant couples in a Chinese community.
| Status | Completed |
| Enrollment | 290 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. 18 years of age or older 2. Expectant couples with the pregnant women attending antenatal clinic in Princess Margaret Hospital before 20 weeks of gestation. Exclusion Criteria: 1. Expected couples who are unable to communicate in Cantonese, Putonghua or English. 2. Multiple pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Princess Margaret Hospital | New Territories |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong | Kwong Wah Hospital, Princess Margaret Hospital, Hong Kong, University of Michigan |
Hong Kong,
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Depressive Symptoms at 3 months postpartum | The Edinburgh Postnatal Depression Scale is used to measure women's distressed mood or dysphoria at baseline and also at 3 months postpartum | Baseline and 3 months postpartum | No |
| Secondary | Change from Baseline in Parental Competence at 3 months postpartum | The Parental Sense of Competence Scale is used to measure parenting efficacy and satisfaction at baseline and also at 3 months postpartum | Baseline and 3 months postpartum | No |
| Secondary | Change from Baseline in Marital Satisfaction at 3 months postpartum | The Dyadic Adjustment Scale is used to measure couples' consensus, cohesion, satisfaction and affection expression at baseline and also at 3 months postpartum | Baseline and 3 months postpartum | No |