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

This study is currently recruiting participants.
Verified October 2012 by Rhode Island Hospital
Sponsor:
Information provided by (Responsible Party):
Esther Choo, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01709552
First received: August 10, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Computer-based Intervention for Women With Substance Use and Intimate Partner Violence in the Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Change in past-month drug use days [ Time Frame: 1 month, 3 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Based on readiness to change rulers.

  • Change in readiness to change scale for relationship safety behaviors. [ Time Frame: 2 weeks, 1 month, 3 months ] [ Designated as safety issue: No ]
    Based on readiness to change rulers.


Estimated Enrollment: 44
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709552

Contacts
Contact: Esther K Choo, MD MPH 401-444-8731 echoo@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Department of Emergency Medicine Recruiting
Providence, Rhode Island, United States, 02903
Contact: Esther K Choo, MD MPH     401-444-8731     echoo@lifespan.org    
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Esther K Choo, MD MPH Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Esther Choo, Assistant Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01709552     History of Changes
Other Study ID Numbers: 5K23DA031881-02
Study First Received: August 10, 2012
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013