The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
Primary Purpose
Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Psychoeducation program
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Depressive symptoms, marital relationship, quality of life
Eligibility Criteria
Inclusion Criteria:
- aged 18 or above;
- first-time parents;
- able to speak and read the Chinese language; and
- Hong Kong residents.
Exclusion Criteria:
- couples with past or family psychiatric history
Sites / Locations
- The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Psychodeucation program
Mother only
Control group
Arm Description
Both couples receive the father inclusive psychoeducation program which consists of a single 3-hour session during pregnancy and two telephone follow up at postpartum.
Only the women receives the psychoeducation program.
Receives usual perinatal care services only
Outcomes
Primary Outcome Measures
Edinburgh Postnatal Depression Scale
Secondary Outcome Measures
Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale
Dyadic Adjustment Scale
Dyadic Adjustment Scale
Dyadic Adjustment Scale
Medical Outcomes Study Short Form 12-item Health Survey
Medical Outcomes Study Short Form 12-item Health Survey
Medical Outcomes Study Short Form 12-item Health Survey
Full Information
NCT ID
NCT02010840
First Posted
December 4, 2013
Last Updated
December 1, 2015
Sponsor
The University of Hong Kong
Collaborators
Education Bureau, The Government of the Hong Kong Special Administrative Region
1. Study Identification
Unique Protocol Identification Number
NCT02010840
Brief Title
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
Official Title
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Education Bureau, The Government of the Hong Kong Special Administrative Region
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care.
Detailed Description
Background: Having a first child is a key marker of the transition into parenthood that requires substantial adjustment of couples' life. A recent meta-analysis published in the Journal of American Medical Association reports that both women (23.8%) and men (10.4%) suffer from perinatal depression [1]. The father's involvement during pregnancy can positively influence health outcomes not only for the man, but his partner, and their children [1,2]. However, the effectiveness of father's involvement in prenatal care in preventing paternal and maternal depression, is still unknown.
Aims: This study seeks to: (1) evaluate the effect of a father inclusive psychoeducation program for first-time Chinese mothers and fathers on depressive symptoms (primary outcome), marital relationships and quality of life at 6 weeks, 6 months and one year postpartum; and (2) explore fathers' involvement, their perceived benefits of participating in the program and factors influencing the effectiveness of the program.
Methods: This study employs a longitudinal, randomized, pre and post-test design. A convenience sample of 576 couples will be recruited at antenatal clinics and randomly assigned to one of three groups: (1) the experimental group with both couples receives the intervention on top of usual perinatal care; (2) the comparison group with only the women receives the intervention on top of usual perinatal care; and (3) the control group receives usual perinatal care only. The intervention consists of a single 3-hour session during pregnancy and two telephone follow-up at postpartum week one and week two. Primary outcome on postnatal depression will be assessed by Edinburgh Postnatal Depression Scale. Secondary outcomes on marital relationship and quality of life will be assessed by Dyadic Adjustment Scale and Medical Outcomes Study Short Form 12-item Health Survey, respectively, at baseline, 6 weeks, 6 months and one year postpartum. Process evaluation will be conducted at 6 weeks postpartum using individual telephone interview on 20 couples randomly selected from the experimental group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Depressive symptoms, marital relationship, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychodeucation program
Arm Type
Experimental
Arm Description
Both couples receive the father inclusive psychoeducation program which consists of a single 3-hour session during pregnancy and two telephone follow up at postpartum.
Arm Title
Mother only
Arm Type
Active Comparator
Arm Description
Only the women receives the psychoeducation program.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Receives usual perinatal care services only
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation program
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Time Frame
6 months postpartum
Title
Edinburgh Postnatal Depression Scale
Time Frame
12 months postpartum
Title
Dyadic Adjustment Scale
Time Frame
6 weeks postpartum
Title
Dyadic Adjustment Scale
Time Frame
6 months postpartum
Title
Dyadic Adjustment Scale
Time Frame
12 months postpartum
Title
Medical Outcomes Study Short Form 12-item Health Survey
Time Frame
6 weeks postpartum
Title
Medical Outcomes Study Short Form 12-item Health Survey
Time Frame
6 months postpartum
Title
Medical Outcomes Study Short Form 12-item Health Survey
Time Frame
12 months postpartum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 or above;
first-time parents;
able to speak and read the Chinese language; and
Hong Kong residents.
Exclusion Criteria:
couples with past or family psychiatric history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Wan Ngai, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wan Ngai, PhD
Email
fwngai@gmail.com
First Name & Middle Initial & Last Name & Degree
Fei Wan Ngai, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
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