NCT00280488

Brief Summary

The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 25, 2010

Status Verified

June 1, 2010

Enrollment Period

5.9 years

First QC Date

January 19, 2006

Last Update Submit

June 24, 2010

Conditions

Keywords

Motivational InterviewingAlcohol AbuseAlcohol DependenceEmergency Care Setting

Outcome Measures

Primary Outcomes (2)

  • Alcohol Consumption

    12 months

  • Alcohol-related problems (e.g., drinking and driving)

    12 months

Secondary Outcomes (1)

  • Cost-effectiveness of intervention

    12 months

Study Arms (3)

1) MI with SO

ACTIVE COMPARATOR

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.

Behavioral: Motivational Interview

2) MI with patient only

ACTIVE COMPARATOR

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient

Behavioral: Motivational Interview

3) Assessment only

ACTIVE COMPARATOR

In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

Behavioral: Assessment

Interventions

Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

2) MI with patient only
AssessmentBEHAVIORAL

In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

3) Assessment only

Eligibility Criteria

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

You may qualify if:

  • admitted to trauma unit
  • greater than 18 years old
  • had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
  • identify at least one eligible significant other

You may not qualify if:

  • not English-speaking
  • had a self-inflicted injury
  • in police custody
  • did not pass a mental status exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational InterviewingRestraint, Physical

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Peter Monti, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

May 1, 2005

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 25, 2010

Record last verified: 2010-06

Locations