Back to resultsBrief Intervention for Substance Use and Partner Abuse Among Females in the ER (B-SAFER)
Primary Purpose
Substance Related Disorders, Domestic Violence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Intervention
Control
Sponsored by
About this trial
This is an interventional treatment trial for Substance Related Disorders
Eligibility Criteria
Inclusion Criteria:
- ≥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
Exclusion Criteria:
Patients who are:
- intoxicated
- medically unstable as determined by ED staff
- suicidal ideation
- psychosis
- combative
- in police custody
Sites / Locations
- Rhode Island Hospital Department of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Computer Intervention
Control
Arm Description
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
Outcomes
Primary Outcome Measures
Change in past-month drug use days
Drug use based on Timeline Followback.
Change in use of relationship safety behaviors and referral resources for IPV.
Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.
Secondary Outcome Measures
Change in readiness to change drug use.
Based on readiness to change rulers.
Change in readiness to change scale for relationship safety behaviors.
Based on readiness to change rulers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01709552
Brief Title
Brief Intervention for Substance Use and Partner Abuse Among Females in the ER
Acronym
B-SAFER
Official Title
A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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). This project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders, Domestic Violence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer Intervention
Arm Type
Experimental
Arm Description
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
Intervention Type
Behavioral
Intervention Name(s)
Computer Intervention
Intervention Description
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
Primary Outcome Measure Information:
Title
Change in past-month drug use days
Description
Drug use based on Timeline Followback.
Time Frame
1 month, 3 month
Title
Change in use of relationship safety behaviors and referral resources for IPV.
Description
Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.
Time Frame
2 weeks, 1 month, 3 months
Secondary Outcome Measure Information:
Title
Change in readiness to change drug use.
Description
Based on readiness to change rulers.
Time Frame
2 week, 1 month, 3 months
Title
Change in readiness to change scale for relationship safety behaviors.
Description
Based on readiness to change rulers.
Time Frame
2 weeks, 1 month, 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
Patients who are:
intoxicated
medically unstable as determined by ED staff
suicidal ideation
psychosis
combative
in police custody
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther K Choo, MD MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital Department of Emergency Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Intervention for Substance Use and Partner Abuse Among Females in the ER
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