The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Psychoeducation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychodeucation program<br>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. | Behavioral: Psychoeducation program<br> <br> |
| Active Comparator: Mother only<br>Only the women receives the psychoeducation program. | Behavioral: Psychoeducation program<br> <br> |
| No Intervention: Control group<br>Receives usual perinatal care services only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale |  | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale |  | 6 months postpartum | 
| Edinburgh Postnatal Depression Scale |  | 12 months postpartum | 
| Dyadic Adjustment Scale |  | 6 weeks postpartum | 
| Dyadic Adjustment Scale |  | 6 months postpartum | 
| Dyadic Adjustment Scale |  | 12 months postpartum | 
| Medical Outcomes Study Short Form 12-item Health Survey |  | 6 weeks postpartum | 
| Medical Outcomes Study Short Form 12-item Health Survey |  | 6 months postpartum | 
| Medical Outcomes Study Short Form 12-item Health Survey |  | 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive symptoms, marital relationship, quality of life