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Completed

NCT Number: NCT02010840

The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation program

Behavioral

Primary outcomes

  1. Edinburgh Postnatal Depression Scale

    Time frame: 6 weeks postpartum

    Edinburgh Postnatal Depression Scale

Secondary outcomes

  1. Edinburgh Postnatal Depression Scale

    Time frame: 6 months postpartum

  2. Edinburgh Postnatal Depression Scale

    Time frame: 12 months postpartum

  3. Dyadic Adjustment Scale

    Time frame: 6 weeks postpartum

  4. Dyadic Adjustment Scale

    Time frame: 6 months postpartum

  5. Dyadic Adjustment Scale

    Time frame: 12 months postpartum

  6. Medical Outcomes Study Short Form 12-item Health Survey

    Time frame: 6 weeks postpartum

  7. Medical Outcomes Study Short Form 12-item Health Survey

    Time frame: 6 months postpartum

  8. Medical Outcomes Study Short Form 12-item Health Survey

    Time frame: 12 months postpartum

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Education Bureau, The Government of the Hong Kong Special Administrative Region

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2013
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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