NCT01709552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

August 10, 2012

Last Update Submit

May 21, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in past-month drug use days

    Drug use based on Timeline Followback.

    1 month, 3 month

  • Change in use of relationship safety behaviors and referral resources for IPV.

    Based on Safety Behavior Checklist and Effectiveness in Obtaining Resources scales.

    2 weeks, 1 month, 3 months

Secondary Outcomes (2)

  • Change in readiness to change drug use.

    2 week, 1 month, 3 months

  • Change in readiness to change scale for relationship safety behaviors.

    2 weeks, 1 month, 3 months

Study Arms (2)

Computer Intervention

EXPERIMENTAL

Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.

Behavioral: Computer Intervention

Control

SHAM COMPARATOR

Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.

Behavioral: Control

Interventions

Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.

Computer Intervention
ControlBEHAVIORAL

Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • Patients who are:
  • intoxicated
  • medically unstable as determined by ED staff
  • suicidal ideation
  • psychosis
  • combative
  • in police custody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital Department of Emergency Medicine

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Esther K Choo, MD MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2012

First Posted

October 18, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations