NCT02010840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

October 29, 2025

Status Verified

June 1, 2017

Enrollment Period

3.7 years

First QC Date

December 4, 2013

Results QC Date

October 1, 2025

Last Update Submit

October 1, 2025

Conditions

Pregnancy

Keywords

Depressive symptoms, marital relationship, quality of life

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale

    Edinburgh Postnatal Depression Scale

    6 weeks postpartum

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Psychodeucation program

EXPERIMENTAL

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

Mother only

ACTIVE COMPARATOR

Only the women receives the psychoeducation program.

Behavioral: Psychoeducation program

Control group

NO INTERVENTION

Receives usual perinatal care services only

Interventions

Psychoeducation programBEHAVIORAL
Mother onlyPsychodeucation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 or above;
  • first-time parents;
  • able to speak and read the Chinese language; and
  • Hong Kong residents.

You may not qualify if:

  • couples with past or family psychiatric history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Vivian Ngai
Organization
The Hog Kong Polytechnic University
vivian.ngai@polyu.edu.hk
2766

Study Officials

  • Fei Wan Ngai, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 13, 2013

Study Start

May 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 29, 2025

Results First Posted

October 29, 2025

Record last verified: 2017-06

Locations

HK(1)