Alcohol AbusePhase 2NCT00289965
Substance Use Risk Education (SURE) Project
A Phase 2 study testing Counselor-administered Brief Motivational Intervention (BMI), Alcohol 101 Plus (interactive CD-ROM) and AlcoholEdu (Internet-based tutorial) in people with Alcohol Abuse and Alcohol Drinking, run by Syracuse University at 1 site in United States.
Trial summary
This project is designed to compare college drinking interventions on outcomes and cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Alcohol Drinking
- What is being tested?
- Counselor-administered Brief Motivational Intervention (BMI), Alcohol 101 Plus (interactive CD-ROM) and AlcoholEdu (Internet-based tutorial)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2009
- Phase
- Phase 2
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Freshman, sophomore, and junior college students
- Students sanctioned for an alcohol-related violation on campus
Who cannot join
- Year in college: senior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Alcohol Interventions by Counselor vs Computer
This project is designed to compare college drinking interventions on outcomes and cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. We will also explore which participants might respond better to one intervention vs the others.
Read the detailed description
Many college students engage in heavy episodic drinking, a pattern that increases risks of undesired academic, social, health, and legal consequences. Fortunately, brief motivational interventions - when administered during face-to-face sessions by a trained counselor - can help students to reduce their heavy drinking and related consequences. However, use of such counselor-administered interventions on college campuses remains infrequent; instead, administrators rely on computerized brief interventions because they can be administered with fewer staff at lower cost. Two computer-administered interventions (AlcoholEdu and Alcohol 101 Plus) are used by more than 1,000 colleges and universities nationwide, even though these interventions have not been evaluated in controlled studies. Despite the magnitude of the college-drinking problem, no data have addressed the differential efficacy (or cost-effectiveness) of the computer-administered versus counselor-administered brief motivational interventions. Thus, the primary purpose of the proposed research is to address gaps in the scientific literature by evaluating outcomes of three types of brief motivational interventions: a theoretically-based and empirically-tested counselor-administered intervention and the two most popular computerized interventions. A secondary purpose of the proposed research is to identify predictors of outcomes, and moderators associated with differential intervention response. A tertiary purpose is to assess the cost-effectiveness of three types of brief motivational interventions. The proposed research will be a randomized controlled trial with four treatment conditions and four assessment occasions. We will recruit at-risk student drinkers who have been sanctioned to receive an alcohol education intervention because they violated a residence hall policy. These referred students will be randomized to one of the three interventions, or to a delayed intervention control; and assessed at baseline and again 1, 6, and 12 months later on key drinking and drinking consequences outcomes.
- Conditions
- Alcohol Abuse, Alcohol Drinking
- Being tested
- Counselor-administered Brief Motivational Intervention (BMI), Alcohol 101 Plus (interactive CD-ROM), AlcoholEdu (Internet-based tutorial)
- Keywords
- Alcohol Abuse, Alcohol Drinking, Intervention Studies, Computer-Assisted Instruction, College Students
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselor-administered Brief Motivational Intervention (BMI)Behavioural
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
Alcohol 101 Plus (interactive CD-ROM)Behavioural
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
AlcoholEdu (Internet-based tutorial)Behavioural
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | in-person brief motivational intervention Receives: Behavioral: Counselor-administered Brief Motivational Intervention (BMI) |
| 2 | Active comparator | Alcohol 101plus Receives: Behavioral: Alcohol 101 Plus (interactive CD-ROM) |
| 3 | Active comparator | AlcoholEdu (a Web-based tutorial). Receives: Behavioral: AlcoholEdu (Internet-based tutorial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of drinks per week
Measured: 12 months
drinks per drinking day
Measured: 12 months
frequency of heavy drinking episodes
Measured: 12 months
peak blood alcohol concentration (BAC)
Measured: 12 months
Rutgers Alcohol Problems Index (RAPI) score
Measured: 12 months
Secondary outcomes (4)
readiness to change
Measured: 12 months
decisional balance
Measured: 12 months
client satisfaction
Measured: 12 months
norms perception
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Kate B. Carey, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289965
- Sponsor's protocol ID
- NIAAACAR012518-06
- Other IDs
- R01AA012518, NIH Grant 2R01AA012518-06
- Status last verified
- Jul 2011
- First submitted
- 8 Feb 2006
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez AC, Yurasek AM, Merrill JE, Miller MB, Zamboanga BL, Carey KB, Borsari B. Do brief motivational interventions reduce drinking game frequency in mandated students? An analysis of data from two randomized controlled trials. Psychol Addict Behav. 2017 Feb;31(1):36-45. doi: 10.1037/adb0000239. Epub 2016 Dec 12.
PubMed 27936818
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Alcohol Interventions by Counselor vs Computer
- ClinicalTrials.gov ID
- NCT00289965
- Acronym / sponsor ID
- NIAAACAR012518-06
- Conditions
- Alcohol Abuse, Alcohol Drinking
- Keywords
- Alcohol Abuse, Alcohol Drinking, Intervention Studies, Computer-Assisted Instruction, College Students
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Feb 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.
This project is designed to compare college drinking interventions on outcomes and cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. We will also explore which participants might respond better to one intervention vs the others.
Detailed description
Many college students engage in heavy episodic drinking, a pattern that increases risks of undesired academic, social, health, and legal consequences. Fortunately, brief motivational interventions - when administered during face-to-face sessions by a trained counselor - can help students to reduce their heavy drinking and related consequences. However, use of such counselor-administered interventions on college campuses remains infrequent; instead, administrators rely on computerized brief interventions because they can be administered with fewer staff at lower cost. Two computer-administered interventions (AlcoholEdu and Alcohol 101 Plus) are used by more than 1,000 colleges and universities nationwide, even though these interventions have not been evaluated in controlled studies. Despite the magnitude of the college-drinking problem, no data have addressed the differential efficacy (or cost-effectiveness) of the computer-administered versus counselor-administered brief motivational interventions. Thus, the primary purpose of the proposed research is to address gaps in the scientific literature by evaluating outcomes of three types of brief motivational interventions: a theoretically-based and empirically-tested counselor-administered intervention and the two most popular computerized interventions. A secondary purpose of the proposed research is to identify predictors of outcomes, and moderators associated with differential intervention response. A tertiary purpose is to assess the cost-effectiveness of three types of brief motivational interventions. The proposed research will be a randomized controlled trial with four treatment conditions and four assessment occasions. We will recruit at-risk student drinkers who have been sanctioned to receive an alcohol education intervention because they violated a residence hall policy. These referred students will be randomized to one of the three interventions, or to a delayed intervention control; and assessed at baseline and again 1, 6, and 12 months later on key drinking and drinking consequences outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Counselor-administered Brief Motivational Intervention (BMI)in-person brief motivational intervention |
| 2 | Active comparator | Behavioral: Alcohol 101 Plus (interactive CD-ROM)Alcohol 101plus |
| 3 | Active comparator | Behavioral: AlcoholEdu (Internet-based tutorial)AlcoholEdu (a Web-based tutorial). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Freshman, sophomore, and junior college students
- Students sanctioned for an alcohol-related violation on campus
Key exclusion criteria (1 listed)
- Year in college: senior
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 |
|---|---|---|
| Counselor-administered Brief Motivational Intervention (BMI)Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. | Behavioural | 1 |
| Alcohol 101 Plus (interactive CD-ROM)Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. | Behavioural | 2 |
| AlcoholEdu (Internet-based tutorial)Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. | Behavioural | 3 |
Primary outcome
mean number of drinks per week
Time frame: 12 months
drinks per drinking day
Time frame: 12 months
frequency of heavy drinking episodes
Time frame: 12 months
peak blood alcohol concentration (BAC)
Time frame: 12 months
Rutgers Alcohol Problems Index (RAPI) score
Time frame: 12 months
4 secondary outcomes
readiness to change
Time frame: 12 months
decisional balance
Time frame: 12 months
client satisfaction
Time frame: 12 months
norms perception
Time frame: 12 months
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 26 Jul 2011.
- Derived from this study: PubMed 27936818Fernandez AC, Yurasek AM, Merrill JE, Miller MB, Zamboanga BL, Carey KB, Borsari B. Do brief motivational interventions reduce drinking game frequency in mandated students? An analysis of data from two randomized controlled trials. Psychol Addict Behav. 2017 Feb;31(1):36-45. doi: 10.1037/adb0000239. Epub 2016 Dec 12.
- College Drinking: Changing the Culture - includes research, statistics, approaches to prevention, and interactive tools for students and educators.Link provided by the sponsor.
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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.
Kate B. Carey, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counselor-administered Brief Motivational Intervention (BMI), Alcohol 101 Plus (interactive CD-ROM) and AlcoholEdu (Internet-based tutorial) in people with Alcohol Abuse and Alcohol Drinking, run by Syracuse University at 1 site 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 2 inclusion and 1 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
mean number of drinks per week (time frame: 12 months). The study lists 5 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 NCT00289965, which also lists 1 linked publication.
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 26 Jul 2011; AzTrials last refreshed its copy on 27 Oct 2026.