Alcohol ConsumptionNCT00374153
Southern Methodist Alcohol Research Trial (SMART)
A study testing Feedback, Motivational Interview with Feedback and Motivational Interview in people with Alcohol Consumption, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Feedback, Motivational Interview with Feedback and Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Methodist University
Dallas, Texas, 75205
University of Texas School of Public Health Dallas Regional Campus
Dallas, Texas, 75390
About this study
Official title: Dismantling Motivational Interviewing and Feedback for College Drinkers
The purpose of this study is to look at the effects of assessment, feedback and motivational interviewing on alcohol consumption among college drinkers.
Read the detailed 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.
- Conditions
- Alcohol Consumption
- Being tested
- Feedback, Motivational Interview with Feedback, Motivational Interview
- Keywords
- Alcohol, Drinking, College, Motivational, Feedback, Assessment
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
Online personal feedback report
Motivational Interview with FeedbackBehavioural
In-person Motivational Interview with personal feedback report
Motivational InterviewBehavioural
In-person Motivational Interview only (without a personal feedback report)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Online personal feedback report. Receives: Behavioral: Feedback |
| 2 | Experimental | In-person Motivational Interview with personal feedback report Receives: Behavioral: Motivational Interview with Feedback |
| 3 | Experimental | In-person Motivational Interview only (without a personal feedback report) Receives: Behavioral: Motivational Interview |
| 4 | No intervention | Assessment only |
| 5 | No intervention | Delayed Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per week
Measured: one year
Peak BAC
Measured: one year
Secondary outcomes (4)
Alcohol Related Consequences (RAPI)
Measured: one year
Interpersonal Violence (CADRI)
Measured: one year
Readiness to Change (RTCQ)
Measured: one year
Protective Behaviors (PBQ)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Scott T Walters, PhD, Principal investigator, University of Texas School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374153
- Sponsor's protocol ID
- HSC-SPH-06-0310
- Other IDs
- NIAAA, 1 R01 AA016005-01
- Status last verified
- Mar 2010
- First submitted
- 6 Sep 2006
- Last updated
- 10 Mar 2010
- Results posted
- No
Publications
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. doi: 10.1016/j.addbeh.2007.06.022. Epub 2007 Jun 29.
PubMed 17669596Walters 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.
PubMed 19170454Roudsari 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.
PubMed 18981192Harris 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.
PubMed 18980889Walters ST, Vader AM, Harris TR, Jouriles EN. Reactivity to alcohol assessment measures: an experimental test. Addiction. 2009 Aug;104(8):1305-10. doi: 10.1111/j.1360-0443.2009.02632.x.
PubMed 19624323
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dismantling Motivational Interviewing and Feedback for College Drinkers
- ClinicalTrials.gov ID
- NCT00374153
- Acronym / sponsor ID
- HSC-SPH-06-0310
- Conditions
- Alcohol Consumption
- Keywords
- Alcohol, Drinking, College, Motivational, Feedback, Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the effects of assessment, feedback and motivational interviewing on alcohol consumption among college drinkers.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: FeedbackOnline personal feedback report. |
| 2 | Experimental | Behavioral: Motivational Interview with FeedbackIn-person Motivational Interview with personal feedback report |
| 3 | Experimental | Behavioral: Motivational InterviewIn-person Motivational Interview only (without a personal feedback report) |
| 4 | No intervention | –Assessment only |
| 5 | No intervention | –Delayed Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeedbackOnline personal feedback report | Behavioural | 1 |
| Motivational Interview with FeedbackIn-person Motivational Interview with personal feedback report | Behavioural | 2 |
| Motivational InterviewIn-person Motivational Interview only (without a personal feedback report) | Behavioural | 3 |
Primary outcome
Drinks per week
Time frame: one year
Peak BAC
Time frame: one year
4 secondary outcomes
Alcohol Related Consequences (RAPI)
Time frame: one year
Interpersonal Violence (CADRI)
Time frame: one year
Readiness to Change (RTCQ)
Time frame: one year
Protective Behaviors (PBQ)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
- Results publication: PubMed 17669596Walters 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. doi: 10.1016/j.addbeh.2007.06.022. Epub 2007 Jun 29.
- Results publication: PubMed 19170454Walters 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.
- Results publication: PubMed 18981192Roudsari 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.
- Results publication: PubMed 18980889Harris 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.
- Derived from this study: PubMed 19624323Walters ST, Vader AM, Harris TR, Jouriles EN. Reactivity to alcohol assessment measures: an experimental test. Addiction. 2009 Aug;104(8):1305-10. doi: 10.1111/j.1360-0443.2009.02632.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott T Walters, PhD principal investigator
University of Texas School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback, Motivational Interview with Feedback and Motivational Interview in people with Alcohol Consumption, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks per week (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374153, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2010.