Pregnancy Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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