Brief Intervention for Substance Use and Partner Abuse Among Females in the ER (B-SAFER)

May 21, 2015 updated by: Esther Choo, Rhode Island Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Department of Emergency Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer Intervention
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Behavioral: Computer Intervention
Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
Sham Comparator: Control
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
Behavioral: Control
Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in past-month drug use days
Time Frame: 1 month, 3 month
Drug use based on Timeline Followback.
1 month, 3 month
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 weeks, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in readiness to change drug use.
Time Frame: 2 week, 1 month, 3 months
Based on readiness to change rulers.
2 week, 1 month, 3 months
Change in readiness to change scale for relationship safety behaviors.
Time Frame: 2 weeks, 1 month, 3 months
Based on readiness to change rulers.
2 weeks, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Esther K Choo, MD MPH, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5K23DA031881-02 (U.S. NIH Grant/Contract)

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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