Motivational Interviewing for Alcohol-Positive Teens in the Emergency Room
Primary Purpose
Alcohol Abuse, Alcohol Dependence
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
Eligibility Criteria
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
Sites / Locations
- Rhode Island Hospital
- Brown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
MI
Outcomes
Primary Outcome Measures
Alcohol Consumption
Secondary Outcome Measures
Alcohol-related problems (e.g., drinking and driving)
Full Information
NCT ID
NCT00246428
First Posted
October 27, 2005
Last Updated
December 6, 2007
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00246428
Brief Title
Motivational Interviewing for Alcohol-Positive Teens in the Emergency Room
Official Title
Motivational Interviewing (MI) for ETOH+ Teens in the ER
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence
Keywords
Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MI
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI
Intervention Description
Experimental manipulations will be evaluated 6, 9, and 12 months
Primary Outcome Measure Information:
Title
Alcohol Consumption
Time Frame
6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Alcohol-related problems (e.g., drinking and driving)
Time Frame
6, 9, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Monti, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20402989
Citation
Barnett NP, Apodaca TR, Magill M, Colby SM, Gwaltney C, Rohsenow DJ, Monti PM. Moderators and mediators of two brief interventions for alcohol in the emergency department. Addiction. 2010 Mar;105(3):452-65. doi: 10.1111/j.1360-0443.2009.02814.x.
Results Reference
derived
Learn more about this trial
Motivational Interviewing for Alcohol-Positive Teens in the Emergency Room
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