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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 20, 2014