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临床试验/NCT02370394
NCT02370394已完成不适用

Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)

Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2015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
53
试验地点
1
主要终点
Composite Abuse Scale (CAS)-CAS Victimization Total Score

研究概览

简要总结

The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.

详细描述

Intimate partner violence (IPV) is a significant social and public health problem among perinatal women. Research suggests that from 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places a woman at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Experts in the field advocate for more IPV screening and intervention to take place among women who are at high-risk for IPV. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings (e.g. primary care) are more effective sites for focused case finding and intervention. Further, the presence of IPV increases the likelihood of disengagement from treatment, which could compromise the ability of women with IPV to effectively use important shelter and community resources necessary for establishing safety for themselves and their children. A timely intervention might reduce the risk of future IPV, improve treatment utilization, and reduce mental health symptoms. A brief intervention that is designed specifically for the unique needs of perinatal women with IPV seeking mental health treatment provides a tremendous opportunity to intervene with a group of women who are particularly vulnerable and who might be unusually open to making changes to their lives.

This study is the first step towards developing a computer-based brief intervention ("Reach Out for a Safe Environment") that targets intimate partner violence in perinatal women in mental health treatment and constitutes the developmental aims of a larger study. The aims were to perform a small open trial (n = 8) of the Reach Out for a Safe Environment (ROSE) intervention to assess feasibility of recruitment of target population and acceptability of intervention and study procedures. Also, to conduct a randomized controlled pilot study in a sample of 50 perinatal women seeking mental health treatment who screen positive for recent IPV to demonstrate the acceptability and feasibility of the ROSE intervention via participant report of ease of use, helpfulness, and overall satisfaction.

We collected several measures on the feasibility of the research design, the acceptability of ROSE, and on intervention effects for IPV severity and level of self-care strategies (primary outcomes), motivation and self efficacy (secondary outcomes), and use of recommended mental health treatment services (tertiary outcome). This phase used a two-group, randomized, controlled design with an initial session for both conditions plus booster session one month later for the intervention condition. The initial intervention session was conducted close to an intake visit for mental health difficulties, with a booster session within one month following baseline. There was a 3-month follow up assessment. Assessments and the booster session were conducted in a private room or at a location that was a convenient location for the woman and one that provided a confidential, safe, and comfortable environment for the participant.

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
None

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

  • •Pregnant or postpartum women (up to 6 months after delivery)
  • •Age 18 or older
  • •Seeking mental health treatment at The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH)
  • •Endorsed any IPV during the past 12 months as measured by the Woman Abuse Screening Tool (WAST)

排除标准

  • •Inability to provide informed consent (e.g., due to psychosis, intoxication, or other clear cognitive impairment)
  • •Inability to understand English (understand the consent form when read aloud and assessments that are narrated by computer)

研究组 & 干预措施

ROSE Program

Experimental

Participants received a 35-40-minute intervention on the Tablet PC and an in-person 10-15-minute booster session conducted by interventionists within a month after the intervention. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.

干预措施: ROSE Program (Behavioral)

Control Condition

No Intervention

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

结局指标

主要结局

Composite Abuse Scale (CAS)-CAS Victimization Total Score

时间窗: Assessed at baseline, and again three months later

A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.

Effectiveness in Obtaining Resources Scale (EOR)

时间窗: Assessed at baseline, and again three months later

Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.

Safety Behavior Checklist (SBC)

时间窗: Assessed at baseline, and again three months later

Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.

次要结局

  • Motivation Scale(Assessed at baseline, and again three months later)
  • The Readiness to Change Contemplation Ladder(Assessed at baseline, and again three 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 (1)

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