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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00374153
Other study ID # HSC-SPH-06-0310
Secondary ID NIAAA, 1 R01 AA0
Status Completed
Phase N/A
First received September 6, 2006
Last updated March 9, 2010
Start date September 2006
Est. completion date January 2009

Study information

Verified date March 2010
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at the effects of assessment, feedback and motivational interviewing on alcohol consumption among college drinkers.


Description:

Excessive alcohol consumption has been a growing problem at many US colleges. In response, colleges and universities have instituted a range of alcohol intervention and prevention programs for students. Motivational Interviewing (MI) is one brief intervention that has been shown to reduce heavy drinking among college students. To date, all college studies of MI have used a format that includes an assessment and feedback delivered in an MI style. Although this format has considerable empirical support, it remains unclear which of the components is necessary to produce behavior change. This study will evaluate the separate and collective effects of MI and feedback among "binge" drinking college students. Additionally, this study will evaluate the effects of the initial drinking assessment, through including a delayed-assessment control group. After an initial screen, 350 students at Southern Methodist University who report at least one heavy (i.e., "binge") episode during the previous two weeks will be randomized to: (1) MI with feedback, (2) MI without feedback, (3) Mailed feedback only, (4) Assessment only, or (5) Delayed assessment only. MI sessions will be delivered by trained and supervised counselors. Participants will be assessed via a secure Internet site at baseline, 3, 6 and 12 months (12 months only for the Delayed-assessment group), with primary outcome measures including self-reported quantity and frequency of drinking, and drinking-related problems. Since college drinking is associated with substantial negative effects for drinkers, as well as for others, the findings of this study may have significant public health implications in terms of reducing costs, and improving services for students who choose to drink.


Recruitment information / eligibility

Status Completed
Enrollment 363
Est. completion date January 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants must be enrolled in Southern Methodist University.

- Participants must report one "binge" episode (4 or more drinks in one setting for women, 5 or more drinks in one setting for men) in the past two weeks.

- Participants must be at least 18 years old.

Exclusion Criteria:

- Participants will be excluded if they are not enrolled at Southern Methodist University.

- Participants will be excluded if they do not report at least one "binge" episode in the past two weeks.

- Participants will be excluded if they are less than 18 years old.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Feedback
Online personal feedback report
Motivational Interview with Feedback
In-person Motivational Interview with personal feedback report
Motivational Interview
In-person Motivational Interview only (without a personal feedback report)

Locations

Country Name City State
United States Southern Methodist University Dallas Texas
United States University of Texas School of Public Health Dallas Regional Campus Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Harris TR, Walters ST, Leahy MM. Readiness to change among a group of heavy-drinking college students: correlates of readiness and a comparison of measures. J Am Coll Health. 2008 Nov-Dec;57(3):325-30. doi: 10.3200/JACH.57.3.325-330. — View Citation

Roudsari BS, Leahy MM, Walters ST. Correlates of dating violence among male and female heavy-drinking college students. J Interpers Violence. 2009 Nov;24(11):1892-905. doi: 10.1177/0886260508325492. Epub 2008 Nov 3. — View Citation

Walters ST, Roudsari BS, Vader AM, Harris TR. Correlates of protective behavior utilization among heavy-drinking college students. Addict Behav. 2007 Nov;32(11):2633-44. Epub 2007 Jun 29. — View Citation

Walters ST, Vader AM, Harris TR, Field CA, Jouriles EN. Dismantling motivational interviewing and feedback for college drinkers: a randomized clinical trial. J Consult Clin Psychol. 2009 Feb;77(1):64-73. doi: 10.1037/a0014472. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Drinks per week one year Yes
Primary Peak BAC one year Yes
Secondary Alcohol Related Consequences (RAPI) one year Yes
Secondary Interpersonal Violence (CADRI) one year Yes
Secondary Readiness to Change (RTCQ) one year No
Secondary Protective Behaviors (PBQ) one year Yes
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