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Intervention for Battered Sheltered Women With Substance Use Randomized Trial

Primary Purpose

Intimate Partner Violence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHE Program
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intimate Partner Violence focused on measuring Intimate Partner Violence, Sheltered Battered Women, Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • New Hope
  • Battered Women's Shelter of Summit and Medina Counties
  • Center for Women's Behavioral Health at Women and Infants' Hospital
  • Sojourner House

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SHE Program

Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Treatment Services Review (TSR)
The Treatment Services Review will be used to assess total times using 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 number of times attending substance use services, divided by the number of days in the reporting period.
The Composite Abuse Scale (CAS)
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. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.
The Cyber Stalking Scale
The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).
Safety Behavior Checklist (SBC)
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). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).

Full Information

First Posted
December 2, 2015
Last Updated
April 6, 2020
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02629133
Brief Title
Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Official Title
Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intimate Partner Violence
Keywords
Intimate Partner Violence, Sheltered Battered Women, Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHE Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHE Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version
Description
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.
Time Frame
Assessed at baseline, and at 3 and 6 months post shelter
Secondary Outcome Measure Information:
Title
The Treatment Services Review (TSR)
Description
The Treatment Services Review will be used to assess total times using 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 number of times attending substance use services, divided by the number of days in the reporting period.
Time Frame
Assessed at baseline, and again at 3 and 6 months later
Title
The Composite Abuse Scale (CAS)
Description
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. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.
Time Frame
Assessed at baseline, and again at 3 and 6 months after shelter release
Title
The Cyber Stalking Scale
Description
The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).
Time Frame
Assessed at baseline, and again at 3 and 6 months later
Title
Safety Behavior Checklist (SBC)
Description
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). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).
Time Frame
Assessed at baseline, and again at 3 and 6 months after shelter release

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caron Zlotnick, PhD
Organizational Affiliation
Women and Infants' Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Hope
City
Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02703
Country
United States
Facility Name
Battered Women's Shelter of Summit and Medina Counties
City
Akron
State/Province
Ohio
ZIP/Postal Code
44305
Country
United States
Facility Name
Center for Women's Behavioral Health at Women and Infants' Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Sojourner House
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intervention for Battered Sheltered Women With Substance Use Randomized Trial

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