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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709552
First Posted: October 18, 2012
Last Update Posted: May 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esther Choo, Rhode Island Hospital
  Purpose
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.

Condition Intervention
Substance Related Disorders Domestic Violence Behavioral: Computer Intervention Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department

Further study details as provided by Esther Choo, Rhode Island Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in readiness to change drug use. [ Time Frame: 2 week, 1 month, 3 months ]
    Based on readiness to change rulers.

  • Change in readiness to change scale for relationship safety behaviors. [ Time Frame: 2 weeks, 1 month, 3 months ]
    Based on readiness to change rulers.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709552


Locations
United States, Rhode Island
Rhode Island Hospital Department of Emergency Medicine
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Esther K Choo, MD MPH Rhode Island Hospital
  More Information

Responsible Party: Esther Choo, Assistant Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01709552     History of Changes
Other Study ID Numbers: 5K23DA031881-02 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2012
First Posted: October 18, 2012
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders