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临床试验/NCT05250258
NCT05250258尚未招募不适用

Telephone Peer Support for New Fathers to Prevent Depressive Symptoms After the Child's Birth

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Changes of Postpartum Depressive symptoms

研究概览

简要总结

The overall purpose of the pilot study is to investigate whether telephone support from fathers to fathers reduces depressive symptoms and stress among new fathers in Sweden. Forty expectant fathers with the Edinburgh Postnatal Depression Scale (EPDS)> 10 two weeks after the birth of the child are divided into two groups where half are allocated to telephone support by other fathers (intervention) as a complement to existing parental support, other group get traditionally existing parental support (control). The fathers in the intervention group were allocated telephone-based support from volunteers who have father experience, not mental illness and have undergone training through this project. These volunteers will be trained and supported by trained mentors. Four months after the child is born, data is collected with questionnaires. The intervention group will be compared with the control group and the results from the pilot study form the basis for the forthcoming RCT. Karolinska Institutet's ethics committee has approved the study. Clinical relevance: The long-term goal of this project is to improve the methods for reducing mental illness among fathers, which leads to a positive development for their children and can be used in the development of clinical guidelines to identify and reduce fathers' stress and depressive symptoms.

详细描述

The overall aim of the present study is to examine if telephone based peer support to fathers can reduce or prevent depressive symptoms among new fathers in Sweden. Primary outcome: Depressive symptoms, measured by EPDS (Edinburg Postnatal Depression Scale).

Study hypothesis:

It is hypothesized that the provision of telephone-based peer support will reduce depressive symptoms and anxiety among fathers.

Design and methods A pilot controlled clinical trial will be conducted and the different steps are built upon earlier developed peer support.

Fathers will be assigned to telephone based peer support by a coordinator. In this study, fathers will be linked with a peer volunteer during the first ten days after childbirth. Telephone contact will be initiated within 48 to 72 hours of trial randomization and then as frequently as the dyad seems necessary. Peer volunteer have experienced fatherhood and have participated in a 12-hour training program by mentors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged 18 - 49 years old,
  • Less than two weeks postpartum
  • Scored more than ten on the -Edingburg postnatal depression scale (EPDS ) scale <10 = indicate depression
  • Swedish or English speaking

排除标准

  • Current use of anti-depressant or anti-psychotic medication

结局指标

主要结局

Changes of Postpartum Depressive symptoms

时间窗: Baseline and follow up 3 months and one year after the invention

Changes in Postpartum Depressive symptoms (PPD), assesed by measured by EPDS (Edinburg postpartumdepression scale) more than 10 score on EPDS= indicate depressive symptoms for fathers, minimum=0 maximum=30 Postpartum Depressive symptoms (PPD), as measured by EPDS (Edinburg postnatal depression scale (Cox et al 1994)

次要结局

  • Changes of Anxiety symptoms(Baseline and follow up 3 months and one year after the invention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ewa Andersson

adjunct professor

Karolinska Institutet

研究点 (1)

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