- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383551
"Becoming Parents": A Hospital-community Partnership
December 12, 2013 updated by: TIWARI, Agnes, The University of Hong Kong
"Becoming Parents": A Hospital-community Partnership to Enhance Transition to Parenthood
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Transition to parenthood is potentially a stressful life event for many new parents, which, if not properly managed, could have adverse effects on their mental health, marital satisfaction, and parent-child relationships.
The proposed programme, "Becoming Parents", aims to turn the challenges of the transition into opportunities of learning and support for these parents.
Building on our experience of instituting a pioneering programme to support new fathers prenatally, "Becoming Parents" has an extra component of support for new parents in the postnatal period using trained volunteers from the community networks.
Through "Becoming Parents", seamless antenatal-postnatal care based on a hospital-community partnership will be provided to 125 expectant couples in a target community which is known for its high risks for postnatal depression, child abuse and intimate partner violence.
In addition to addressing the health promotional needs of the target community, "Becoming Parents" will also illustrate how a community's capacity for health promotion can be maximized through the collaboration of healthcare providers and network of community partners in helping couples function more optimally during their transition to parenthood.
Study Type
Interventional
Enrollment (Anticipated)
290
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Territories, Hong Kong
- Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Expectant couples with the pregnant women attending antenatal clinic in Princess Margaret Hospital before 20 weeks of gestation.
Exclusion Criteria:
- Expected couples who are unable to communicate in Cantonese, Putonghua or English.
- Multiple pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Becoming Parents" intervention
A "Becoming Parents" Programme consists of: (i) 3 antenatal workshops conducted over a period of 10-14 weeks in prenatal period; and (ii) support provided by trained volunteers for up to 3 months post-delivery; in addition to the usual prenatal education.
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A "Becoming Parents" programme consists of: (i) 3 antenatal workshops conducted over a period of 10-14 weeks in prenatal period; and (ii) support provided by trained volunteers for up to 3 months post-delivery; in addition to the usual prenatal education.
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No Intervention: Usual prenatal education
Attend usual prenatal classes which will be provided by the midwives in the hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Depressive Symptoms at 3 months postpartum
Time Frame: Baseline and 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
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Baseline and 3 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Parental Competence at 3 months postpartum
Time Frame: Baseline and 3 months postpartum
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The Parental Sense of Competence Scale is used to measure parenting efficacy and satisfaction at baseline and also at 3 months postpartum
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Baseline and 3 months postpartum
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Change from Baseline in Marital Satisfaction at 3 months postpartum
Time Frame: Baseline and 3 months postpartum
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The Dyadic Adjustment Scale is used to measure couples' consensus, cohesion, satisfaction and affection expression at baseline and also at 3 months postpartum
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Baseline and 3 months postpartum
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aston ML. Learning to be a normal mother: empowerment and pedagogy in postpartum classes. Public Health Nurs. 2002 Jul-Aug;19(4):284-93. doi: 10.1046/j.1525-1446.2002.19408.x.
- Doherty WJ, Erickson MF, LaRossa R. An intervention to increase father involvement and skills with infants during the transition to parenthood. J Fam Psychol. 2006 Sep;20(3):438-47. doi: 10.1037/0893-3200.20.3.438.
- Walther VN. Postpartum depression: a review for perinatal social workers. Soc Work Health Care. 1997;24(3-4):99-111. doi: 10.1300/J010v24n03_08.
- Draper J. Men's passage to fatherhood: an analysis of the contemporary relevance of transition theory. Nurs Inq. 2003 Mar;10(1):66-77. doi: 10.1046/j.1440-1800.2003.00157.x.
- Belsky, J., & Pensky, E. (1998). Marital change across the transition to parenthood. Marriage and Family Review, 12, (3-4), 133-156.
- Krishnakmuar, A., & Buehler, C. (2000). Inter-parental conflict and parenting behaviours: A meta-analytic review. Family Relations, 49, 25-44.
- Cowan, C., & Cowan P. (1995). Interventions to ease the transition to parenthood: Why they are needed and what they can do. Family Relations, 44, 412-414.
- Markman, H., & Hahlweg, K. (1993). The prediction and prevention of marital distress: an international perspective. Clinical Psychology Review, 13, 29-43.
- Minsky, R., Garfinkel, I., & Neprmnyaschy, L. (2005). In-hospital paternity establishment and father involvement in fragile families. Journal of Marriage and the Family, 67(3), 611-626.
- Gottman, J.M., Shapiro, A.F. Parthemer, J. (2004). Bringing Baby Home: A workshop for new and expectant parents. International Journal of Childbirth Education, 19(3), 28-30.
- Early, R. (2001). Men as consumers of maternity services: a contradiction in terms. International Journal of Consumer Studies, 25, 160-167.
- Tiwari, A. Leung, W.C., Yuen, K.H., & Wong, J. (2010). Positive fathering: A programme to enhance the mental health and marital relationship of expectant couples. A progress report for a HCPF-funded project submitted to Research Fund Secretariat, Health Care and Promotion Fund Committee on June 29, 2010.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
May 30, 2011
First Submitted That Met QC Criteria
June 26, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Estimate)
December 16, 2013
Last Update Submitted That Met QC Criteria
December 12, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- UW 11-163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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