Pregnancy
Conditions
Keywords
Depressive symptoms, marital relationship, quality of life
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.
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.
Interventions
BEHAVIORALPsychoeducation program
Sponsors
Education Bureau, The Government of the Hong Kong Special Administrative Region
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale | 6 weeks postpartum | Edinburgh Postnatal Depression Scale |
Secondary
| Measure | Time frame |
|---|---|
| Edinburgh Postnatal Depression Scale | 6 months postpartum |
| Dyadic Adjustment Scale | 6 weeks postpartum |
| Medical Outcomes Study Short Form 12-item Health Survey | 6 weeks postpartum |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 134 |
| Mother Only Only the women receives the psychoeducation program.
Psychoeducation program | 124 |
| Control Group Receives usual perinatal care services only | 130 |
| Total | 388 |
Baseline characteristics
| Characteristic | Total | Psychodeucation Program | Mother Only | Control Group |
|---|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 4 | 32 years STANDARD_DEVIATION 4 | 32 years STANDARD_DEVIATION 4 | 31 years STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Chinese | 388 Participants | 134 Participants | 124 Participants | 130 Participants |
| Sex: Female, Male Female | 194 Participants | 67 Participants | 62 Participants | 65 Participants |
| Sex: Female, Male Male | 194 Participants | 67 Participants | 62 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale
Time frame: 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychodeucation program | Edinburgh Postnatal Depression Scale | 41 score on a scale | Standard Error 0 |
| Mother only | Edinburgh Postnatal Depression Scale | 35 score on a scale | Standard Error 0 |
| Control group | Edinburgh Postnatal Depression Scale | 37 score on a scale | Standard Error 0 |
Secondary
Dyadic Adjustment Scale
Time frame: 6 months postpartum
Secondary
Dyadic Adjustment Scale
Time frame: 6 weeks postpartum
Secondary
Dyadic Adjustment Scale
Time frame: 12 months postpartum
Secondary
Edinburgh Postnatal Depression Scale
Time frame: 6 months postpartum
Secondary
Edinburgh Postnatal Depression Scale
Time frame: 12 months postpartum
Secondary
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 12 months postpartum
Secondary
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 6 weeks postpartum
Secondary
Medical Outcomes Study Short Form 12-item Health Survey
Time frame: 6 months postpartum