Clinical trial NCT02010840: The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression
Official title: The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Depressive symptoms, marital relationship, quality of life
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Education Bureau, The Government of the Hong Kong Special Administrative Region
First posted: 2013-12-13
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 months postpartum
measure: Edinburgh Postnatal Depression Scale
timeFrame: 12 months postpartum
measure: Dyadic Adjustment Scale
timeFrame: 6 weeks postpartum
measure: Dyadic Adjustment Scale
timeFrame: 6 months postpartum
measure: Dyadic Adjustment Scale
timeFrame: 12 months postpartum
measure: Medical Outcomes Study Short Form 12-item Health Survey
timeFrame: 6 weeks postpartum
measure: Medical Outcomes Study Short Form 12-item Health Survey
timeFrame: 6 months postpartum
measure: Medical Outcomes Study Short Form 12-item Health Survey
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Fei Wan Ngai, PhD
role: PRINCIPAL_INVESTIGATOR
References: