Cumulative Victimization and Women's Health Risks: Development of an Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in perceived stress
研究概览
简要总结
The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.
详细描述
The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.
The study will:
- Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
- Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.
The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-55 years of age
- •Self-identify as a female
- •Born in Africa or foreign born from African descent
- •Must have a current or past abusive romantic relationship
- •Must be a survivor of cumulative trauma
- •Clinically significant symptoms of PTSD and/or depression
- •At least one sexual HIV risk behavior
排除标准
- •Less than 18 years of age or more than age 55
- •Self-identify as a male
- •Not African-born immigrant or born outside the US
- •Is not a survivor of cumulative trauma
- •Does not meet clinically significant criteria of PTSD and/or depression
- •Does not report at least one sexual HIV risk behavior
结局指标
主要结局
Change in perceived stress
时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The Perceived stress scale is a 10 item self-report measure of stress. It is designed to assess how stressed one feels in the past month. Item responses are rated on a 5-point scale ranging from 0 (Never) to 4 (Very often). Higher scores indicate higher perceived stress. This scale is scored by summing the answers to all items, for a highest score of 40. Scores 0-13 indicate low stress, 14-26 is moderate stress and 27-40 is considered high stress.
Change in empowerment related to safety as assessed by the MOVERS scale
时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The MOVERS is a 13 item scale that measures empowerment within the domain of safety. Participants respond to each item using a five-point scale from 1- "never true" to 5 - "always true". A maximum total of 65 and minimum of 13. Higher scores indicate higher level of empowerment related to safety.
Change in sexual risk behaviors
时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
The Safe Sex Behavior Questionnaire is a 27-item self-report measure that describes sexual behaviors such as condom usage, sexual communication, and high-risk sexual behaviors. Item responses are rated on a 4-point scale ranging from 1 (Never) to 4 (Always). There are no subscales, and all items are summed to create a total score. Higher scores indicate engagement in safer sexual behaviors
Change in depressive symptoms
时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The Patient Health Questionnaire (PHQ-9) is a 9 item measure to assess depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV). Each of the 9 items scores from 0 (not at all) to 3 (nearly every day).
Change in symptoms of post-traumatic stress disorder (PTSD)
时间窗: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Harvard Trauma Questionnaire (16 items) is used to measure symptoms of PTSD derived from the DSM-IIR/DSM-IV criteria for PTSD. The scale for each question includes four categories of response: "Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively
次要结局
- Change in overall empowerment as assessed by the Personal Progress Scale-Revised(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in Sexually Transmitted Disease (STD) knowledge using the STD Knowledge Questionnaire(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in attitudes for stress management as assessed by the Inventory of Positive Psychological Attitudes(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in self-efficacy related to coping with trauma as assessed by the Trauma Coping Self-Efficacy scale(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)])
- Change in self-efficacy for HIV/Sexually Transmitted Infection (STI) prevention as assessed by the Self-Efficacy for STI-HIV Scale(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in severity and frequency of violence(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in HIV knowledge using the HIV Knowledge Questionnaire(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in utilization of healthcare services(Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months))
- Change in physiological stress responses(Assessment time points, Baseline, 3 months and 6 months)