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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00246428
Other study ID # NIAAAMON09892-10
Secondary ID NIH Grant AA0989
Status Active, not recruiting
Phase Phase 3
First received October 27, 2005
Last updated December 6, 2007
Start date January 2000
Est. completion date July 2003

Study information

Verified date December 2007
Source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 198
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

1. Admitted to ER

2. Between 18-24 years old

3. 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:

1. Not English-speaking

2. Had a self-inflicted injury

3. In police custody

4. Did not pass a mental status exam

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
Experimental manipulations will be evaluated 6, 9, and 12 months

Locations

Country Name City State
United States Brown University Providence Rhode Island
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Consumption 6, 9, and 12 months Yes
Secondary Alcohol-related problems (e.g., drinking and driving) 6, 9, and 12 months Yes
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