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
|Condition or disease||Intervention/treatment||Phase|
|Intimate Partner Violence||Behavioral: SHE Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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).
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
|United States, Massachusetts|
|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|
|Woonsocket, Rhode Island, United States, 02895|
|Principal Investigator:||Caron Zlotnick, PhD||Women and Infants' Hospital|