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Intervention for Battered Sheltered Women With Substance Use Randomized Trial

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ClinicalTrials.gov Identifier: NCT02629133
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Caron Zlotnick, Women and Infants Hospital of Rhode Island

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: SHE Program Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: SHE Program
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.
Behavioral: SHE Program
The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.

No Intervention: Control Condition
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.



Primary Outcome Measures :
  1. Alcohol and Substance Use: Timeline Follow-back (TLFB)-modified computer version [ Time Frame: 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, 3 months post shelter, and 6 months post shelter.


Secondary Outcome Measures :
  1. The Treatment Services Review (TSR) [ Time Frame: Assessed at baseline, and again at 3 and 6 months later ]
    The Treatment Services Review will be used to assess total days of substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess total days of substance use services received for a 90 day window.

  2. The Composite Abuse Scale (CAS) [ Time Frame: Assessed at baseline, and again at 3 and 6 months later ]
    The CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer "never", "only once", "several times", "monthly", "weekly" or "daily" in a twelve month period.

  3. The Cyber Stalking Scale [ Time Frame: Assessed at baseline, and again at 3 and 6 months later ]
    The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment.

  4. Safety Behavior Checklist (SBC) [ Time Frame: Assessed at baseline, and again at 3 and 6 months later ]
    Safety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629133


Locations
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United States, Massachusetts
New Hope
Attleboro, Massachusetts, United States, 02703
United States, Ohio
Battered Women's Shelter of Summit and Medina Counties
Akron, Ohio, United States, 44305
United States, Rhode Island
Center for Women's Behavioral Health at Women and Infants' Hospital
Providence, Rhode Island, United States, 02905
Sojourner House
Woonsocket, Rhode Island, United States, 02895
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Caron Zlotnick, PhD Women and Infants' Hospital
  Study Documents (Full-Text)

Documents provided by Caron Zlotnick, Women and Infants Hospital of Rhode Island:
Study Protocol  [PDF] March 15, 2017
Statistical Analysis Plan  [PDF] December 22, 2017


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Responsible Party: Caron Zlotnick, Director of Behavioral Medicine Research, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02629133     History of Changes
Other Study ID Numbers: 792696
R34DA038770-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Caron Zlotnick, Women and Infants Hospital of Rhode Island:
Intimate Partner Violence
Sheltered Battered Women
Substance Use