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| Name | Class |
|---|---|
| Education Bureau, The Government of the Hong Kong Special Administrative Region | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Mother only | Active Comparator | Only the women receives the psychoeducation program. |
|
| Control group | No Intervention | Receives usual perinatal care services only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale | Edinburgh Postnatal Depression Scale | 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale | 6 months postpartum | |
| Edinburgh Postnatal Depression Scale | 12 months postpartum | |
| Dyadic Adjustment Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fei Wan Ngai, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Psychoeducation program |
| FG001 | Mother only | Only the women receives the psychoeducation program. Psychoeducation program |
| FG002 | Control group | Receives usual perinatal care services only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Psychoeducation program |
| BG001 | Mother Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Edinburgh Postnatal Depression Scale | Edinburgh Postnatal Depression Scale | Posted | Mean | Standard Error | score on a scale | 6 weeks postpartum |
|
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The delivery of a psychoeducation programme probably will not lead to serious adverse events, all-caused mortality or other risks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Psychoeducation program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Ngai | The Hog Kong Polytechnic University | 2766 | 6775 | vivian.ngai@polyu.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2022 | May 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
Only the women receives the psychoeducation program. Psychoeducation program |
| BG002 | Control Group | Receives usual perinatal care services only |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Receives usual perinatal care services only |
|
|
| Secondary | Edinburgh Postnatal Depression Scale | Not Posted | 6 months postpartum | Participants |
| Secondary | Edinburgh Postnatal Depression Scale | Not Posted | 12 months postpartum | Participants |
| Secondary | Dyadic Adjustment Scale | Not Posted | 6 weeks postpartum | Participants |
| Secondary | Dyadic Adjustment Scale | Not Posted | 6 months postpartum | Participants |
| Secondary | Dyadic Adjustment Scale | Not Posted | 12 months postpartum | Participants |
| Secondary | Medical Outcomes Study Short Form 12-item Health Survey | Not Posted | 6 weeks postpartum | Participants |
| Secondary | Medical Outcomes Study Short Form 12-item Health Survey | Not Posted | 6 months postpartum | Participants |
| Secondary | Medical Outcomes Study Short Form 12-item Health Survey | Not Posted | 12 months postpartum | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Mother only | Only the women receives the psychoeducation program. Psychoeducation program | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control group | Receives usual perinatal care services only | 0 | 0 | 0 | 0 | 0 | 0 |
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