- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251342
Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale
April 4, 2007 updated by: Chinese University of Hong Kong
The objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the Edinburgh Postnatal Depression Scale (EPDS) screening programme versus usual clinical practice (usual practice), using randomized controlled trial design.
With the use of the EPDS for the screening of postnatal depression, it is expected that more mothers in need of intervention (including mental health intervention, guidance in childcare and parenting, counseling in family relationships, etc) will be picked up and offered appropriate intervention, compared to the usual practice.
It is hypothesized that the mental health of the group of women under the EPDS screening programme will be better than those under the usual practice, on subsequent follow-up.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
460
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cynthia Leung
- Email: fhssro@dh.gov.hk
Study Locations
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Hong Kong, China
- Recruiting
- Maternal and Child Health Centres, Department of Health
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Contact:
- Cynthia Leung
- Email: fhssro@dh.gov.hk
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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Chinese mothers of newborn babies <= 2 months who are registered with the 4 Maternal and Child Health Centres under study;
- Normally resident in Hong Kong (Hong Kong ID card holder, or HK Birth Certificate [with status of permanent resident indicated established] holder, or people who have been granted unconditional stay in Hong Kong, or passport holders having valid travel document showing the right to land in Hong Kong, or permission to land, or eligibility of HK permanent ID card verified, or entitlement to the right of abode in HK)
Exclusion Criteria:
- Those who do not use the Chinese language (in both the written and spoken form);
- Those who are under active psychiatric contact;
- Those who delivered in hospitals which are still conducting their own EPDS screening programme.
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: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mother's mental health at 6 months postpartum, as measured on the EPDS and General Health Questionnaire-12 (GHQ-12), both being self-report questionnaires.
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Secondary Outcome Measures
Outcome Measure |
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Mother's parenting stress (measured by the Parenting Stress Index, a self-report questionnaire)
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Marital relationship satisfaction (measured by the Chinese Kansas Marital Satisfaction Scale, a self-report questionnaire)
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Marital status and employment status (both father and mother, where applicable) at 6 and 18 months postpartum
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Child health measures, including weight at 6 and 18 months, number of hospitalizations and visits to doctors within the first 6 and 18 months as reported by mother
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Mother's mental health outcome (EPDS and GHQ scores) at 18 months postpartum
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominic TS Lee, M.D., Department of Psychiatry, the Chinese University of Hong Kong
- Principal Investigator: Shirley SL Leung, MPH, Family Health Service, Department of Health, HKSAR
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.
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
October 1, 2005
Study Completion (ANTICIPATED)
January 1, 2008
Study Registration Dates
First Submitted
November 9, 2005
First Submitted That Met QC Criteria
November 9, 2005
First Posted (ESTIMATE)
November 10, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 5, 2007
Last Update Submitted That Met QC Criteria
April 4, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2005.224-T
- CUHK_CCT00019
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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