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临床试验/NCT01175603
NCT01175603已完成2 期

Preventing Postpartum Depression in African American Home Visiting Clients

Johns Hopkins University5 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
82
试验地点
5
主要终点
Depressive Symptoms

研究概览

简要总结

The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.

详细描述

This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child < 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.

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
None

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant or has child < 6 months of age
  • enrolled in home visiting program
  • exhibiting elevated depressive symptoms and/or personal history of clinical depression

排除标准

  • no current clinical depression at time of enrollment

结局指标

主要结局

Depressive Symptoms

时间窗: 3 months post-intervention

Depressive symptoms

时间窗: 6 months post-intervention

次要结局

  • Depressive Episodes(6 Months Post-Intervention)
  • Depressive episodes(3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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