The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

October 1, 2025 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

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: 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.
Active Comparator: Mother only
Only the women receives the psychoeducation program.
No Intervention: Control group
Receives usual perinatal care services only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fei Wan Ngai, PhD, The Hong Kong Polytechnic University

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 (Actual)

May 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimated)

December 13, 2013

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

June 1, 2017

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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