- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788579
Women Initiating New Goals of Safety (WINGS)
Project WINGS: Women Initiating New Goals of Safety
This study aims to conduct a randomized controlled trial that will test the feasibility and preliminary effect of a multimedia version of a computerized multimedia intimate partner violence (IPV) prevention service tool designed to increase identification of IPV victimization and to improve linkages to IPV-related services among female offenders under court supervision or probation, compared to a non-media version of the same IPV screening, brief intervention and referral service delivered by a case manager. The study addresses the following: Primary study aims
- To design and beta-test a Computerized Multimedia IPV Screening, Brief Intervention and Referral Service tool for female offenders under court supervision or probation.
- To obtain preliminary estimates of the effects of the Computerized Multimedia versus the Case Manager IPV service conditions on identification of different types of IPV during the service session and on access to and utilization of IPV services over the three-month follow-up period.
To examine and enhance the feasibility (recruitment, enrollment, fidelity of service delivery, client satisfaction, safety, and retention) for a future larger scale R01 study.
Secondary study aim
- To obtain estimates of the effects of the Computerized Multimedia versus the Case Manager IPV service conditions on recidivism, adherence to drug treatment (e.g., attendance, completion) and abstinence of substance use over the follow-up period, controlling for baseline outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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Brooklyn, New York, United States, 11201
- Brooklyn Probation
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New York City, New York, United States, 10018
- Bronx Community Solutions
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New York City, New York, United States, 10018
- Bronx Probation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- She is 18 or older
- She is currently court supervision at Bronx Community Solutions or a drug treatment court or she is currently on probation.
- She reports using any illicit drug or drinking 4 or more alcoholic drinks in a 6-hour period in the past 90 days or she has been in alcohol or drug treatment in the past 6 months OR if she report attending any drug or alcohol treatment in the past 6 months.
- She reports having had an ongoing intimate, dating or sexual relationship with a male or female partner that lasted 3 or more months in the past year.
- She lives within a 90-minute commute of 125th and Broadway
Exclusion Criteria:
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- The participant is unwilling or unable to commit to completing all the activities in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multimedia WINGS
A one-hour session of a self-paced multimedia IPV screening, brief intervention and referral service delivered on a computer.
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This one-hour computerized multimedia IPV prevention service tool features the same activities as the comparison condition, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance learning and provide individualized feedback.
Thus, the multimedia service tool acts as a roadmap for this service session, prompting participants through the IPV screening, providing psycho-educational content on IPV and how IPV may interact with their substance misuse, providing individualized feedback on their IPV risks based on the screening e, creating a safety plan, defining relationship safety goals and identifying IPV-related service needs, and generating a personal plan for accessing services and contacting agency representative.
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Active Comparator: Caseworker Delivered WINGS
A one-hour session of IPV screening, brief intervention and referral service delivered by a case manager.
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The content for the comparison service condition incorporates the core elements of best practices for IPV screening, safety planning and referrals recommended by the American Medical Association and previous service research.
It also contains brief psycho-educational content on recognizing IPV and how IPV may contribute to drug use and recidivism drawn from previous interventions and demonstrated to have promising effects in reducing rates of both IPV and drug use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with identified Intimate Partner Violence (IPV)
Time Frame: Up to 3 months from baseline
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If participants score a 20 or higher on the Women's Experience with Battering (WEB) survey, if they indicate yes to any of the Partner Abuse Interview or Partner Violence Screen (PVS), the tool will inform participants that they are at risk of IPV.
If participants indicate yes to any severe IPV items, the tool will indicate that they are at risk of life-threatening IPV and should consider taking immediate steps to reduce their risks for IPV.
All other participants will be informed that based on the answers, they do not appear to be at risk for IPV at present, but that they may learn strategies to prevent IPV in the session.
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Up to 3 months from baseline
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Utilization of IPV services
Time Frame: Up to 3 months from baseline
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Up to 3 months from baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louisa Gilbert, PhD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAI2851
- R34DA031325 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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