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临床试验/NCT02010840
NCT02010840已完成不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
388
试验地点
1
主要终点
Edinburgh Postnatal Depression Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 18 or above;
  • •first-time parents;
  • •able to speak and read the Chinese language; and
  • •Hong Kong residents.

排除标准

  • •couples with past or family psychiatric history

研究组 & 干预措施

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.

干预措施: Psychoeducation program (Behavioral)

Mother only

Active Comparator

Only the women receives the psychoeducation program.

干预措施: Psychoeducation program (Behavioral)

Control group

No Intervention

Receives usual perinatal care services only

结局指标

主要结局

Edinburgh Postnatal Depression Scale

时间窗: 6 weeks postpartum

Edinburgh Postnatal Depression Scale

Edinburgh Postnatal Depression Scale

时间窗: 6 weeks postpartum

Edinburgh Postnatal Depression Scale

次要结局

  • Dyadic Adjustment Scale(12 months postpartum)
  • Edinburgh Postnatal Depression Scale(12 months postpartum)
  • Medical Outcomes Study Short Form 12-item Health Survey(12 months postpartum)
  • Medical Outcomes Study Short Form 12-item Health Survey(6 months postpartum)
  • Edinburgh Postnatal Depression Scale(6 months postpartum)
  • Dyadic Adjustment Scale(6 weeks postpartum)
  • Dyadic Adjustment Scale(6 months postpartum)
  • Medical Outcomes Study Short Form 12-item Health Survey(6 weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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