Telephone Peer Support for New Fathers to Prevent Depressive Symptoms After the Child's Birth
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
- 否
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
Ewa Andersson
adjunct professor
Karolinska Institutet
