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临床试验/NCT00601939
NCT00601939招募中不适用

Group Interventions for Abused, Suicidal Black Women

Emory University2 个研究点 分布在 1 个国家目标入组 397 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
397
试验地点
2
主要终点
Change in Suicide Attempt Index

研究概览

简要总结

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

详细描述

Most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. Risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. Since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. The higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. Therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. This study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

The participants in this single-blind study will be randomly placed in one of two treatment groups. One group will receive psychoeducational intervention (PEI) and the other will receive enhanced treatment as usual (ETAU). After screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. One week later, participants will complete a second 1-hour survey. Participants will then be randomly placed in the treatment groups. Participants in both groups will receive treatment at Grady Health System, but those in the PEI group will also attend 10 weekly, 90-minute group sessions. The PEI empowerment group sessions will incorporate cultural, social, and intrapersonal elements. The ETAU group will be given mental health treatment as usual plus an adherence enhancement protocol. Follow-up surveys will occur at Week 10 (after treatment completion) and at Months 6 and 12 post-treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

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

  • Identifies as an African-American female
  • Abusive relationship within the 12 months prior to study entry
  • Suicide attempt within the 12 months prior to study entry
  • Seeks services at Grady Health System

排除标准

  • Score of less than 22 on Mini Mental Status Exam (MMSE)
  • Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)
  • Acutely psychotic

结局指标

主要结局

Change in Suicide Attempt Index

时间窗: Baseline, Week 10, Post-treatment Months 6 and 12

Created for this study, this qualitative screening measure asks if participants have engaged in the suicidal behaviors of intentionally overdosing, cutting self, tried to shoot self or jump from a high place, tried to take life, and attempting suicide.

Change in Index of Spouse Abuse Score

时间窗: Baseline, Week 10, Post-treatment Months 6 and 12

The Index of Spouse Abuse (ISA) is a 30-item instrument where participants report how frequently abuse situations occur where 1 = never and 5 = very frequently. Total scores range from 30 to 150 and higher scores indicate a higher degree of abuse.

Change in Beck Scale for Suicide Ideation Score

时间窗: Baseline, Week 10, Post-treatment Months 6 and 12

The Beck Scale for Suicide (BSS) Ideation consists of 19 items with responses rated on a scale from 0 to 2. Total scores range from 0 to 38 with higher scores indicating greater feelings of suicide ideation.

次要结局

  • Change in Beck Hopelessness Scale(Baseline, Week 10, Post-treatment Months 6 and 12)
  • Change in Beck Depression Inventory- II(Baseline, Week 10, Post-treatment Months 6 and 12)
  • Change in Self-Efficacy Scale for Battered Women(Baseline, Week 10, Post-treatment Months 6 and 12)

研究者

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

Nadine Kaslow

Professor

Emory University

研究点 (2)

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