Substance Related DisordersB-SAFERNCT01709552
Brief Intervention for Substance Use and Partner Abuse Among Females in the ER
A study testing Computer Intervention in people with Substance Related Disorders and Domestic Violence, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Substance Related Disorders, Domestic Violence
- What is being tested?
- Computer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2014
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- English or Spanish language proficiency sufficient to understand and complete study procedures
- moderate drug use in the prior 3 months (by NM-ASSIST)
- IPV victimization in the prior 6 months (by WAST)
- access to a phone
Who cannot join
- Patients who are:
- intoxicated
- medically unstable as determined by ED staff
- suicidal ideation
- psychosis
- combative
- in police custody
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital Department of Emergency Medicine
Providence, Rhode Island, 02903
About this study
Official title: A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department
The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.
- Conditions
- Substance Related Disorders, Domestic Violence
- Being tested
- Computer Intervention, Control
- 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.
Computer InterventionBehavioural
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
ControlBehavioural
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
| Study group | Role | What they receive |
|---|---|---|
| Computer Intervention | Experimental | Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit. Receives: Behavioral: Computer Intervention |
| Control | Sham comparator | Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in past-month drug use days
Drug use based on Timeline Followback.
Measured: 1 month, 3 month
Change in use of relationship safety behaviors and referral resources for IPV.
Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.
Measured: 2 weeks, 1 month, 3 months
Secondary outcomes (2)
Change in readiness to change drug use.
Based on readiness to change rulers.
Measured: 2 week, 1 month, 3 months
Change in readiness to change scale for relationship safety behaviors.
Based on readiness to change rulers.
Measured: 2 weeks, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Choo, Rhode Island Hospital
- Investigators
- Esther K Choo, MD MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709552
- Sponsor's protocol ID
- 5K23DA031881-02
- Acronym
- B-SAFER
- Status last verified
- May 2015
- First submitted
- 10 Aug 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department
- ClinicalTrials.gov ID
- NCT01709552
- Acronym / sponsor ID
- B-SAFER / 5K23DA031881-02
- Conditions
- Substance Related Disorders, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Oct 2012 (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.
The purpose of this study is to target co-occurring problems of substance use and intimate partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for Substance use and partner Abuse for Females in the Emergency Room). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer Intervention | Experimental | Behavioral: Computer InterventionPatients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit. |
| Control | Sham comparator | Behavioral: ControlPatients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- English or Spanish language proficiency sufficient to understand and complete study procedures
- moderate drug use in the prior 3 months (by NM-ASSIST)
- IPV victimization in the prior 6 months (by WAST)
- access to a phone
Key exclusion criteria (7 listed)
- intoxicated
- medically unstable as determined by ED staff
- suicidal ideation
- psychosis
- combative
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 |
|---|---|---|
| Computer InterventionPatients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit. | Behavioural | Computer Intervention |
| ControlPatients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence. | Behavioural | Control |
Primary outcome
Change in past-month drug use days
Time frame: 1 month, 3 month
Drug use based on Timeline Followback.
Change in use of relationship safety behaviors and referral resources for IPV.
Time frame: 2 weeks, 1 month, 3 months
Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.
2 secondary outcomes
Change in readiness to change drug use.
Time frame: 2 week, 1 month, 3 months
Change in readiness to change scale for relationship safety behaviors.
Time frame: 2 weeks, 1 month, 3 months
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 22 May 2015.
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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.
Esther K Choo, MD MPH principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Intervention in people with Substance Related Disorders and Domestic Violence, run by Rhode Island Hospital at 1 site 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 7 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in past-month drug use days (time frame: 1 month, 3 month). 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 22 May 2015.