Expectant CouplesNCT01383551
"Becoming Parents": A Hospital-community Partnership
A study testing "Becoming Parents" intervention in people with Expectant Couples, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Expectant Couples
- What is being tested?
- "Becoming Parents" intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Expectant couples with the pregnant women attending antenatal clinic in Princess Margaret Hospital before 20 weeks of gestation.
Who cannot join
- Expected couples who are unable to communicate in Cantonese, Putonghua or English.
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Expectant Couples
- Being tested
- "Becoming Parents" intervention
- Keywords
- Depression, Marital relationship, Parental competence
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Becoming Parents" interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "Becoming Parents" intervention | Experimental | 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. Receives: Behavioral: "Becoming Parents" intervention |
| Usual prenatal education | No intervention | Attend usual prenatal classes which will be provided by the midwives in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months postpartum
Secondary outcomes (2)
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
Measured: Baseline and 3 months postpartum
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
Measured: Baseline and 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Expectant CouplesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong, Kwong Wah Hospital, University of Michigan
- Responsible party
- Principal investigator, TIWARI, Agnes, The University of Hong Kong
- Investigators
- Agnes Tiwari, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383551
- Sponsor's protocol ID
- UW 11-163
- Status last verified
- Dec 2013
- First submitted
- 30 May 2011
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12071902Doherty 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.
PubMed 16938002Walther VN. Postpartum depression: a review for perinatal social workers. Soc Work Health Care. 1997;24(3-4):99-111. doi: 10.1300/J010v24n03_08.
PubMed 9127907Draper 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.
PubMed 12622806Belsky, 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 at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Becoming Parents": A Hospital-community Partnership to Enhance Transition to Parenthood
- ClinicalTrials.gov ID
- NCT01383551
- Acronym / sponsor ID
- UW 11-163
- Conditions
- Expectant Couples
- Keywords
- Depression, Marital relationship, Parental competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong, Kwong Wah Hospital, University of Michigan
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Becoming Parents" intervention | Experimental | Behavioral: "Becoming Parents" interventionA "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. |
| Usual prenatal education | No intervention | –Attend usual prenatal classes which will be provided by the midwives in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Expectant couples with the pregnant women attending antenatal clinic in Princess Margaret Hospital before 20 weeks of gestation.
Key exclusion criteria (2 listed)
- Expected couples who are unable to communicate in Cantonese, Putonghua or English.
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Becoming Parents" interventionA "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. | Behavioural | "Becoming Parents" intervention |
Primary outcome
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
2 secondary outcomes
Change from Baseline in Parental Competence at 3 months postpartum
Time frame: Baseline and 3 months postpartum
Change from Baseline in Marital Satisfaction at 3 months postpartum
Time frame: Baseline and 3 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 12071902Aston 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.
- Background: PubMed 16938002Doherty 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.
- Background: PubMed 9127907Walther VN. Postpartum depression: a review for perinatal social workers. Soc Work Health Care. 1997;24(3-4):99-111. doi: 10.1300/J010v24n03_08.
- Background: PubMed 12622806Draper 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.
- BackgroundBelsky, J., & Pensky, E. (1998). Marital change across the transition to parenthood. Marriage and Family Review, 12, (3-4), 133-156.
- BackgroundKrishnakmuar, A., & Buehler, C. (2000). Inter-parental conflict and parenting behaviours: A meta-analytic review. Family Relations, 49, 25-44.
- BackgroundCowan, 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.
- BackgroundMarkman, H., & Hahlweg, K. (1993). The prediction and prevention of marital distress: an international perspective. Clinical Psychology Review, 13, 29-43.
- BackgroundMinsky, 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.
- BackgroundGottman, 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.
- BackgroundEarly, R. (2001). Men as consumers of maternity services: a contradiction in terms. International Journal of Consumer Studies, 25, 160-167.
- BackgroundTiwari, 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.
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Recruiting
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Anxiety, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Tiwari, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Becoming Parents" intervention in people with Expectant Couples, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depressive Symptoms at 3 months postpartum (time frame: Baseline and 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383551, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.