- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010840
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychodeucation program
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.
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Active Comparator: Mother only
Only the women receives the psychoeducation program.
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No Intervention: Control group
Receives usual perinatal care services only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edinburgh Postnatal Depression Scale
Time Frame: 6 weeks postpartum
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Edinburgh Postnatal Depression Scale
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6 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Edinburgh Postnatal Depression Scale
Time Frame: 6 months postpartum
|
6 months postpartum
|
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Edinburgh Postnatal Depression Scale
Time Frame: 12 months postpartum
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12 months postpartum
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Dyadic Adjustment Scale
Time Frame: 6 weeks postpartum
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6 weeks postpartum
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|
Dyadic Adjustment Scale
Time Frame: 6 months postpartum
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6 months postpartum
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Dyadic Adjustment Scale
Time Frame: 12 months postpartum
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12 months postpartum
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Medical Outcomes Study Short Form 12-item Health Survey
Time Frame: 6 weeks postpartum
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6 weeks postpartum
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Medical Outcomes Study Short Form 12-item Health Survey
Time Frame: 6 months postpartum
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6 months postpartum
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Medical Outcomes Study Short Form 12-item Health Survey
Time Frame: 12 months postpartum
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12 months postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fei Wan Ngai, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 748113
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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