跳至主要内容
临床试验/NCT00602732
NCT00602732已完成1 期

Intervention for Low-income Pregnant Women With Partner Abuse

Butler Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Longitudinal Interval Follow-up Examination (LIFE)

研究概览

简要总结

This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.

详细描述

Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA.

Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression.

All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Able to speak and read English sufficiently to complete the study procedures
  • Willing and able to receive public assistance
  • Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
  • 35 weeks or less gestation

排除标准

  • Meets current criteria for major depressive disorder or post-traumatic stress disorder

结局指标

主要结局

Longitudinal Interval Follow-up Examination (LIFE)

时间窗: Measured at Year 1

次要结局

  • Revised Conflict Tactic Scale (CTS2)(Measured at Year 1)
  • Edinburgh Postnatal Depression Scale(Measured at Year 1)
  • The Davidson Trauma Scale(Measured at Year 1)
  • The Arizona Social Support Interview Schedule(Measured at Year 1)
  • Parenting Stress Index(Measured at Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验