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临床试验/NCT01372098
NCT01372098已完成不适用

Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits

McMaster University2 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2011年5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
492
试验地点
2
主要终点
Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months

研究概览

简要总结

The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.

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 (Participant)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 16 years and older
  • NFP program participants (woman with first live birth and living in poverty)
  • English speaker

排除标准

  • Woman who cannot communicate in English

结局指标

主要结局

Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months

时间窗: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

次要结局

  • PRIME-MD Patient Health Questionnaire (PHQ-9)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)(6-month postpartum)
  • The Public Health Nurses' Responses to Women Who Are Abused(Collected from nurses at baseline, 12 and 24 months)
  • The TWEAK(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • The Intimate Partner Violence Strategies Index (IPV Strategies)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • The Childhood Trauma Questionnaire (CTQ)(6-month postpartum)
  • Drug Abuse Screening Tool (DAST)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • A modified version of the Health and Social Service Utilization questionnaire(6-,12-, 18-, and 24-month postpartum)
  • Child Protection Service records(24-month postpartum)
  • The Domestic Violence Survivor Assessment (DVSA)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • The SF-12 (v. 2)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • Child health outcomes(Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum)
  • The Composite Abuse Scale (CAS)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
  • SPAN (Startle, Physiological arousal, Anger and Numbness)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)

研究者

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

Harriet L. MacMillan

Professor of Pediatrics

McMaster University

研究点 (2)

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