Intimate Partner ViolencePhase 1WINGSNCT01788579
Women Initiating New Goals of Safety
A Phase 1 study testing Multi-media WINGS and Caseworker Delivered WINGS in people with Intimate Partner Violence, run by Columbia University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Multi-media WINGS and Caseworker Delivered WINGS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brooklyn Probation
Brooklyn, New York, 11201
Bronx Community Solutions
New York, New York, 10018
Bronx Probation
New York, New York, 10018
About this study
Official title: 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.
Read the detailed description
Intimate partner violence is a serious public health problem that disproportionately affects drug-involved female offenders under community supervision. Moreover, accumulating research has found strong associations linking experiencing intimate partner violence (IPV) and continued drug use among women in drug treatment. This research suggests that failure to prevent IPV among drug-involved female offenders under community supervision likely to result in higher rates of relapse, treatment attrition and recidivism and underscores the need to address the IPV service needs among the rapidly growing population of female offenders under community supervision. Computerized multimedia IPV prevention service tools have been shown to be feasible and effective in conducting screening, brief intervention and referral for IPV in medical care settings. The proposed services research addresses the significant public health problem of IPV victimization and a co-occurring risk for relapse and recidivism among drug-involved female offenders under court supervision or probation. The proposed computerized tool employs a self-paced, multimedia format to conduct IPV screening, brief intervention and IPV-related service referrals that is informed by best IPV screening and referral practices and previous intervention research. This innovative tool represents a cost-effective option that may implemented with greater fidelity and result in better client satisfaction and IPV prevention outcomes. Furthermore, if found to be effective in identifying IPV and improving linkage to IPV services, this cost effective computerized service tool may be scaled up with ease and speed in court and probation settings in New York State and nationwide.
- Conditions
- Intimate Partner Violence
- Being tested
- Multi-media WINGS, Caseworker Delivered WINGS
- Keywords
- Intimate Partner Violence (IPV), Drug Abuse, Criminal Justice
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-media WINGSBehavioural
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.
Caseworker Delivered WINGSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia WINGS | Experimental | A one-hour session of a self-paced multimedia IPV screening, brief intervention and referral service delivered on a computer. Receives: Behavioral: Multi-media WINGS |
| Caseworker Delivered WINGS | Active comparator | A one-hour session of IPV screening, brief intervention and referral service delivered by a case manager. Receives: Behavioral: Caseworker Delivered WINGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with identified Intimate Partner Violence (IPV)
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.
Measured: Up to 3 months from baseline
Utilization of IPV services
Measured: Up to 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Louisa Gilbert, Columbia University
- Investigators
- Louisa Gilbert, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788579
- Sponsor's protocol ID
- AAAI2851
- Other IDs
- R34DA031325
- Acronym
- WINGS
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project WINGS: Women Initiating New Goals of Safety
- ClinicalTrials.gov ID
- NCT01788579
- Acronym / sponsor ID
- WINGS / AAAI2851
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate Partner Violence (IPV), Drug Abuse, Criminal Justice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intimate partner violence is a serious public health problem that disproportionately affects drug-involved female offenders under community supervision. Moreover, accumulating research has found strong associations linking experiencing intimate partner violence (IPV) and continued drug use among women in drug treatment. This research suggests that failure to prevent IPV among drug-involved female offenders under community supervision likely to result in higher rates of relapse, treatment attrition and recidivism and underscores the need to address the IPV service needs among the rapidly growing population of female offenders under community supervision. Computerized multimedia IPV prevention service tools have been shown to be feasible and effective in conducting screening, brief intervention and referral for IPV in medical care settings. The proposed services research addresses the significant public health problem of IPV victimization and a co-occurring risk for relapse and recidivism among drug-involved female offenders under court supervision or probation. The proposed computerized tool employs a self-paced, multimedia format to conduct IPV screening, brief intervention and IPV-related service referrals that is informed by best IPV screening and referral practices and previous intervention research. This innovative tool represents a cost-effective option that may implemented with greater fidelity and result in better client satisfaction and IPV prevention outcomes. Furthermore, if found to be effective in identifying IPV and improving linkage to IPV services, this cost effective computerized service tool may be scaled up with ease and speed in court and probation settings in New York State and nationwide.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia WINGS | Experimental | Behavioral: Multi-media WINGSA one-hour session of a self-paced multimedia IPV screening, brief intervention and referral service delivered on a computer. |
| Caseworker Delivered WINGS | Active comparator | Behavioral: Caseworker Delivered WINGSA one-hour session of IPV screening, brief intervention and referral service delivered by a case manager. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-media WINGSThis 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. | Behavioural | Multimedia WINGS |
| Caseworker Delivered WINGSThe 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. | Behavioural | Caseworker Delivered WINGS |
Primary outcome
Number of subjects with identified Intimate Partner Violence (IPV)
Time frame: Up to 3 months from baseline
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.
Utilization of IPV services
Time frame: Up to 3 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Gilbert, PhD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multi-media WINGS and Caseworker Delivered WINGS in people with Intimate Partner Violence, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with identified Intimate Partner Violence (IPV) (time frame: Up to 3 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.