- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00246428
Motivational Interviewing for Alcohol-Positive Teens in the Emergency Room
June 11, 2025 updated by: Brown University
Motivational Interviewing (MI) for ETOH+ Teens in the ER
The purpose of this study is to determine whether motivational interviewing is effective in reducing alcohol consumption and alcohol problems among young adults who present to an Emergency Room.
Study Overview
Status
Completed
Conditions
Detailed Description
The long term objectives of this program of research are to develop effective interventions for reducing problem drinking and associated problems among adolescents and young adults and to further enhance intervention approaches by identifying effective elements of treatment derived from cognitive behavioral social learning theory.
Current approaches to behavior change in this area frequently rely on school-based primary prevention programs that do not address cessation/reduction issues for adolescents who are already drinking, rarely address motivational issues related to use and abuse, and cannot target school dropouts.
Recently, two studies have shown Motivational Interviewing (MI) to be effective with alcohol-involved adolescents when compared to a control or no intervention condition, but have shown greater harm-reduction effects than alcohol consumption effects.
In addition, mechanisms of MI have not been elucidated.
The major purposes of this study re to compare MI to a minimal contrast condition in which personalized feedback is provided, and to determine if additional booster sessions will enhance outcomes.
The population is older adolescents who have been treated in an Emergency Department (ED) following an alcohol-related event.
Thus, school dropouts, a high-risk population, will be included in the study.
A 2 (MI versus Feedback Only) x 2 (two booster sessions versus no boosters) factorial design will be used to examine whether a MI combined with booster can effectively change subsequent alcohol use and alcohol problems.
Experimental manipulations will be evaluated 6, 9, and 12 months after baseline intervention.
The study design has several strengths: (1) it will enable an investigation of the main effects of MI versus Feedback Only, providing a more stringent test of the active ingredients of MI than our current competitive segment permitted; (2) it enables an evaluation of the effects of continued contact as a separate factor; and (3) it allows a test of the interaction between baseline intervention type and booster contact.
A secondary purpose of the study is to use explicit mediational analyses, tested within a Structural Equation Modeling framework, to examine the hypothesis that stage of change, use of behavioral alcohol reduction strategies, and alcohol treatment seeking will mediate the relationship between intervention and outcome.
Finally, the study will determine whether the diagnosis of alcohol abuse or dependence affects responsivity to our intervention.
In addition to its potential contribut8ion to theory, the importance of this work is its potential for providing a cos-effective brief intervention at a "teachable moment" to increase high-risk patients' interest in reducing harmful drinking and related risk-taking behaviors.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Admitted to ER
- Between 18-24 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)
Exclusion Criteria:
- Not English-speaking
- Had a self-inflicted injury
- In police custody
- Did not pass a mental status exam
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual Interventional Inteview
45 minute counseling session
|
Individual counseling sessions with emphasis in personal responsibility, exploration of motivation for drinking and review of potential negative consequences.
will be evaluated 6, 9, and 12 months
Other Names:
|
|
Experimental: Individual Motivational Interview + Family Check UP
Same counseling session as Individual Motivational Interview plus a one hour videotaped family assessment, consisting of the parents and the adolescents discussion family beliefs regarding alcohol, and marijuana.
|
One hour videotaped session of family assessment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Alcohol Consumption
Time Frame: 6, 9, and 12 months
|
6, 9, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Alcohol-related problems (e.g., drinking and driving)
Time Frame: 6, 9, and 12 months
|
6, 9, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Monti, PhD, Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2003
Primary Completion (Actual)
January 31, 2008
Study Completion (Actual)
April 30, 2008
Study Registration Dates
First Submitted
October 27, 2005
First Submitted That Met QC Criteria
October 27, 2005
First Posted (Estimated)
October 30, 2005
Study Record Updates
Last Update Posted (Actual)
June 13, 2025
Last Update Submitted That Met QC Criteria
June 11, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAAMON09892-10
- NIH Grant AA09892-10
- R01AA009892 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.