Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00019

2 Trial Registration Date

2005-10-19

i Registration Status

Prospective

3 Secondary IDs

NIL

4 Source(s) of Funding

NIL

5 Primary Sponsor

NIL

6 Secondary Sponsor

NIL

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Shirley Leung/ Dr. Cynthia Leung

ii Address

iii Phone

fhssro@dh.gov.hk

iv Email

email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Dominic T.S. Lee

ii Address

iii Phone

dominiclee@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Outcome of postnatal depression screening using Edinburgh Postnatal Depression Scale

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

NIL

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-10-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Behaviors and Mental Disorders

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Edinburgh Postnatal Depression Scale (a 10-item self-report questionnaire used for screening postnatal depression)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

10 Minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

NIL

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Chinese mothers of newborn babies <= 2 months who are registered with the 4 Maternal and Child Health Centres under study, and who are 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) and those under active psychiatric contact will be excluded. Those who delivered in hospitals which are still conducting their own EPDS screening programme will also be excluded from the study.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-10-19

21 Target Sample Size

460

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The primary outcome measures are 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.

24 Secondary Outcome

The secondary outcome measure are mother's parenting stress (measured by the Parenting Stress Index, a self-report questionnaire), marital relationship satisfaction (measured by the Chinese Kansas Marital Satisfaction Scale, a self-report questionnaire), marital status and employment status (both father and mother, where applicable) at 6 and 18 months postpartum, and 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. Mother's mental health outcome (EPDS and GHQ scores) at 18 months postpartum are also secondary outcome measures.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-10-19