The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

Pregnancy Clinical Trial

Official title:

The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02010840
• Other study ID #: 748113
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 1, 2015
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster
• Study type: Interventional

Clinical 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 perinatal care.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1152
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression, Postpartum
• Pregnancy

Intervention

Behavioral:
• Psychoeducation program

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Education Bureau, The Government of the Hong Kong Special Administrative Region

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale		6 weeks postpartum	No
Secondary	Edinburgh Postnatal Depression Scale		6 months postpartum	No
Secondary	Edinburgh Postnatal Depression Scale		12 months postpartum	No
Secondary	Dyadic Adjustment Scale		6 weeks postpartum	No
Secondary	Dyadic Adjustment Scale		6 months postpartum	No
Secondary	Dyadic Adjustment Scale		12 months postpartum	No
Secondary	Medical Outcomes Study Short Form 12-item Health Survey		6 weeks postpartum	No
Secondary	Medical Outcomes Study Short Form 12-item Health Survey		6 months postpartum	No
Secondary	Medical Outcomes Study Short Form 12-item Health Survey		12 months postpartum	No