NCT00244049

Brief Summary

The goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2004

Longer than P75 for phase_3

Status
completed

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, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
5.4 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

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

6.9 years

First QC Date

October 21, 2005

Last Update Submit

December 5, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in binge/high-risk drinking in college-aged students.

    6-months

Secondary Outcomes (1)

  • c) fr. of accidents, d) fr. of campus vandalism and interaction police; e) academic perf; f) fr. of unwanted sex; g) fr. of high-risk sex; h) fr. of physical altercations i) ER visits and hospital days; and j) cost vs. benefit of the intervention.

    6-months

Study Arms (1)

Brief clinician advice

EXPERIMENTAL
Behavioral: counselingOther: Brief Intervention

Interventions

counselingBEHAVIORAL

Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.

Brief clinician advice

Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.

Brief clinician advice

Eligibility Criteria

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

You may qualify if:

  • subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview

You may not qualify if:

  • Students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention Female students who are pregnant at the time of randomization Students who are currently suicidal at the time of the baseline interview Students under 18 years of age Students who drink more than 200 drinks in 28 days (referred for treatment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Interventions

CounselingCrisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy

Study Officials

  • Michael Fleming, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 25, 2005

Study Start

May 1, 2004

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

December 8, 2014

Record last verified: 2014-12