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临床试验/NCT00604604
NCT00604604已完成不适用

An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression

University of Toronto14 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
702
试验地点
14
主要终点
Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)

研究概览

简要总结

The primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.

详细描述

Many new mothers from diverse cultures experience postpartum depression (PPD), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. While the cause of PPD remains unclear, research consistently demonstrates the importance of psychosocial variables. The purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of PPD among mothers identified as high-risk. Public health nurses using the Edinburgh Postnatal Depression Scale (EPDS) screened mothers who were less than 2 weeks postpartum in the regions of Toronto, Peel, Halton, York, Windsor, Sudbury, and Ottawa. Eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). Diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. The results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of PPD among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the EPDS in general public health nursing practice; and (6) present valuable information regarding PPD among a multicultural Canadian population.

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 (Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • live birth
  • discharged from hospital
  • <2 weeks postpartum
  • scored >9 on the EPDS
  • availability of a peer volunteer who speaks the potential participant's language

排除标准

  • infant not discharged home with mother
  • current use of anti-depressant or anti-psychotic medication
  • prior self-reported mental illness, including prior PPD, will NOT be an exclusion criterion

结局指标

主要结局

Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)

时间窗: 12 weeks postpartum

次要结局

  • State Anxiety Inventory (STAI); UCLA Loneliness Scale; Maternal Health Service Utilization and Cost of Care Questionnaire; Peer Support Evaluation Inventory; Peer Volunteer Experience Questionnaire; Peer Volunteer Activity Log(12 and 24 weeks postpartum)

研究者

申办方类型
Other

研究点 (14)

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