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临床试验/NCT03265847
NCT03265847已完成不适用

Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 688 人开始时间: 2017年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
688
试验地点
2
主要终点
Change in severity and frequency of physical violence

研究概览

简要总结

This study evaluates the impact of administering culturally-specific versions of the Danger Assessment (DA) tool followed by the tailored safety planning/referral via use of internet/smartphone-based safety decision aid (SDA) on immigrant, refugee and indigenous women's empowerment, safety and mental health. Half of survivors will receive tailored safety planning/referral based on their level of risk assessed by the DA, while the other half will receive non-DA informed usual safety planning/referral.

详细描述

The DA is a tool to assess risk for homicide, near homicide, re-assault or severe re-assault by an intimate partner. In the culturally adapted DA-informed safety decision aid intervention, women answer questions on the DA, receive immediate feedback on their level of danger as well as personalized messages about safety based on their scores on the DA. The risk factors and scores on the DA are then combined with the safety priorities of women to develop a tailored safety action with links to community resources. Using a computerized randomization scheme, women are randomly assigned to either the internet and/or smartphone app accessible SDA website or control website.

This trial is being conducted in various geographical regions in the US to address the following aims:

  1. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's safety compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased safety seeking behaviors and reduced exposure to intimate partner violence in comparison to the control group.
  2. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's mental health compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have improved mental health in comparison to the control group.
  3. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on promoting abused women's empowerment compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased empowerment in comparison to the control group.

The study will establish evidence base for a culturally-informed intervention for immigrant, refugee and indigenous women. The intervention will not only prevent future exposure to intimate partner violence, it will also promote abused women's mental health and empowerment.

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
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Experiences of intimate partner violence within the past one year
  • Foreign born immigrant or refugee woman OR Native American woman
  • 18-64 years of age
  • Can access and use internet

排除标准

  • No experience of intimate partner violence within the past one year
  • US born and not Native American
  • Younger than 18 or older than 64
  • Cannot access or use internet

结局指标

主要结局

Change in severity and frequency of physical violence

时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

The adapted version of the Revised Conflict Tactics Scale (CTS2; Straus 1996) is used to measure severity and frequency of the abusive or violent acts in intimate partner relationships. The CTS2 subscales include physical aggression, injury, psychological aggression and sexual coercion. Response categories range from 0=never to 6= more than 20 times within the past 12 months; 7 = not in referent period but happened before. Higher values on the measure within the past 12 months indicate severe or more frequent experiences of violence. The CTS-2 items are scored using the severity-times-frequency weighted score, as recommended by Straus.

次要结局

  • Change in depressive symptoms(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
  • Change in symptoms of post-traumatic stress disorder (PTSD)(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
  • Change in overall empowerment(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
  • Change in empowerment related to safety(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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