- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01383551
"Becoming Parents": A Hospital-community Partnership
12. december 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
290
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
New Territories, Hong Kong
- Princess Margaret Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: "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.
|
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.
|
|
Ingen indgriben: Usual prenatal education
Attend usual prenatal classes which will be provided by the midwives in the hospital.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Depressive Symptoms at 3 months postpartum
Tidsramme: 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
|
Baseline and 3 months postpartum
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Parental Competence at 3 months postpartum
Tidsramme: Baseline and 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
|
|
Change from Baseline in Marital Satisfaction at 3 months postpartum
Tidsramme: Baseline and 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2011
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
30. maj 2011
Først indsendt, der opfyldte QC-kriterier
26. juni 2011
Først opslået (Skøn)
28. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. december 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UW 11-163
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .