PregnancyNCT02010840
The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
A study testing Psychoeducation program in people with Pregnancy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy
- What is being tested?
- Psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above;
- first-time parents;
- able to speak and read the Chinese language; and
- Hong Kong residents.
Who cannot join
- couples with past or family psychiatric history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Psychoeducation program
- Keywords
- Depressive symptoms, marital relationship, quality of life
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducation program |
| Mother only | Active comparator | Only the women receives the psychoeducation program. Receives: Behavioral: Psychoeducation program |
| Control group | No intervention | Receives usual perinatal care services only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale
Measured: 6 weeks postpartum
Secondary outcomes (8)
Edinburgh Postnatal Depression Scale
Measured: 6 months postpartum
Edinburgh Postnatal Depression Scale
Measured: 12 months postpartum
Dyadic Adjustment Scale
Measured: 6 weeks postpartum
Dyadic Adjustment Scale
Measured: 6 months postpartum
Dyadic Adjustment Scale
Measured: 12 months postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Measured: 6 weeks postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Measured: 6 months postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Education Bureau, The Government of the Hong Kong Special Administrative Region
- Responsible party
- Sponsor
- Investigators
- Fei Wan Ngai, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010840
- Sponsor's protocol ID
- 748113
- Status last verified
- Jun 2017
- First submitted
- 4 Dec 2013
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02010840
- Acronym / sponsor ID
- 748113
- Conditions
- Pregnancy
- Keywords
- Depressive symptoms, marital relationship, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Education Bureau, The Government of the Hong Kong Special Administrative Region
- Study start
- May 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychodeucation program | Experimental | Behavioral: Psychoeducation programBoth couples receive the father inclusive psychoeducation program which consists of a single 3-hour session during pregnancy and two telephone follow up at postpartum. |
| Mother only | Active comparator | Behavioral: Psychoeducation programOnly the women receives the psychoeducation program. |
| Control group | No intervention | –Receives usual perinatal care services only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or above;
- first-time parents;
- able to speak and read the Chinese language; and
- Hong Kong residents.
Key exclusion criteria (1 listed)
- couples with past or family psychiatric history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation program | Behavioural | Mother only, Psychodeucation program |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: 6 weeks postpartum
Edinburgh Postnatal Depression Scale
8 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 6 months postpartum
Edinburgh Postnatal Depression Scale
Time frame: 12 months postpartum
Dyadic Adjustment Scale
Time frame: 6 weeks postpartum
Dyadic Adjustment Scale
Time frame: 6 months postpartum
Dyadic Adjustment Scale
Time frame: 12 months postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 6 weeks postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 6 months postpartum
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 12 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Wan Ngai, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation program in people with Pregnancy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.