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临床试验/NCT02629133
NCT02629133已完成不适用

Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial

Women and Infants Hospital of Rhode Island4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version

研究概览

简要总结

This study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that addresses known barriers in early identification and intervention with sheltered battered women with IPV (intimate partner violence) and substance use.

详细描述

Intimate partner violence (IPV) and substance use are significant and interconnected public health problems facing women. For battered women, the presence of substance use increases the risk of revictimization and the risk of more severe abuse. Battered women's shelters provide emergency shelter to approximately 300,000 women and children each year. A prime time to intervene with battered women might be when they enter a shelter and have already initiated a change in their lives. A shelter-based intervention for battered women that addresses substance use problems might reduce the risk of substance use, reduce the risk of future IPV, and improve utilization of substance use treatment and community resources. The objective of this R34 Award was to develop and assess an innovative, easily implementable, low-cost, computer-delivered intervention, the SHE Program (Safe and Healthy Experiences) that addresses known barriers in early identification and intervention for battered sheltered women with substance use issues. SHE is based on motivational interviewing (MI) a well-defined intervention strategy that has yielded particularly promising results in a range of clinical issues and a range of patient populations, including substance using women. MI is consistent with an empowerment model, which is a highly recommended intervention model for victimized women. The R34 had two distinct phases to assess the SHE Program with battered sheltered women with substance use issues. During the Development Phase, the research team conducted focus groups and developed the intervention to meet the needs of our target group, developed the software for the computer-delivered intervention, and conducted an open trial with 10 participants. During the Pilot Study Phase, the investigators conducted a two-group, randomized controlled study with a sample of 50 battered sheltered women who reported substance use difficulties within the last three months, which provides the necessary groundwork to examine the efficacy of the SHE Program in a future, large clinical trial. The SHE Program was found to be feasible, acceptable and efficacious in improving outcomes for our vulnerable target population. The program has the potential to be widely disseminated while maintaining treatment fidelity across battered women shelters and may hold promise for IPV populations with substance use difficulties in other settings.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • •Women who are 18 or older, residents of a battered women's shelter, who are at risk substance users within the last 3 months as determined by the screener, the NIDA-Modified ASSIST, and endorse IPV within the last 3 months as determined by the screener, the WAST (Woman Abuse Screening Tool)

排除标准

  • •Inability to provide informed consent (e.g., due to florid psychosis or other clear cognitive impairment)
  • •Inability to understand English

研究组 & 干预措施

SHE Program

Experimental

Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.

干预措施: SHE Program (Behavioral)

Control Condition

No Intervention

Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.

结局指标

主要结局

Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version

时间窗: Assessed at baseline, and at 3 and 6 months post shelter

The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.

次要结局

  • The Treatment Services Review (TSR)(Assessed at baseline, and again at 3 and 6 months later)
  • Safety Behavior Checklist (SBC)(Assessed at baseline, and again at 3 and 6 months after shelter release)
  • The Composite Abuse Scale (CAS)(Assessed at baseline, and again at 3 and 6 months after shelter release)
  • The Cyber Stalking Scale(Assessed at baseline, and again at 3 and 6 months later)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caron Zlotnick

Director of Behavioral Medicine Research

Women and Infants Hospital of Rhode Island

研究点 (4)

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