Alcohol UsePhase 1NCT00247182
Stepped Care for Mandated College Students
A Phase 1 study testing Step 1: Minimal Intervention, Step 2: Brief Motivational Intervention and Alcohol Assessment in people with Alcohol Use, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This project provides stepped care to college students mandated for alcohol-related offenses. Students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Step 1: Minimal Intervention, Step 2: Brief Motivational Intervention and Alcohol Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2011
- Phase
- Phase 1
- 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
- Male and female students 18 years of age or older.
- Participants will have signed a witnessed informed consent.
- Participants will have been referred for an alcohol-related offense
Who cannot join
- Participants who meet current DSM-IV criteria for substance use disorder
- Participants who are currently in treatment for substance use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roger Williams University
Bristol, Rhode Island, 02809
About this study
This project provides stepped care to college students mandated for alcohol-related offenses. Students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. Students who continue to drink in a risky manner are provided with a more intensive, hour-long brief motivational interview. By providing more intensive treatment to the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol programs.
Read the detailed description
Colleges and universities have seen a large increase in the number of students referred to the administration for the violation of alcohol policies. However, research indicates that the majority of mandated students may not require extensive treatment. Stepped care assigns individuals to different levels of care according to their response to treatment. Encouraging research indicates that minimal interventions and BMIs may reduce heavy drinking in mandated college students. Thus, implementing stepped care using these interventions could maximize treatment efficiency and reduce the demands on campus alcohol programs.
Participants will be students mandated to attend an alcohol program at a northeastern private university. All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later, and those continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. The three groups will be compared on two outcome measures: frequency of binge drinking episodes and alcohol-related problems in the past 30 days. Predictors of treatment response (readiness to change, alcohol expectancies, age of first drink, sensation seeking, descriptive norms, and reaction to the referral) will also be evaluated for both steps of the intervention. Research findings will assist college alcohol programs in determining the most effective and efficient allocation of their limited resources in treating mandated students. The long-term objectives of this research are to inform preventive intervention research about the utility and cost-effectiveness of stepped-care approaches and to identify individual and situational factors that qualify these effects.
- Conditions
- Alcohol Use
- Being tested
- Step 1: Minimal Intervention, Step 2: Brief Motivational Intervention, Alcohol Assessment
- Keywords
- Stepped Care, Brief Motivational Intervention, Minimal Intervention, Treatment response, College Students
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1: Minimal InterventionBehavioural
All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later. All students will complete 3, 6, and 9 month follow-up assessments
Step 2: Brief Motivational InterventionBehavioural
Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
Alcohol AssessmentBehavioural
Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
| Study group | Role | What they receive |
|---|---|---|
| Step 1 | Other | Minimal Intervention Receives: Behavioral: Step 1: Minimal Intervention; Behavioral: Step 2: Brief Motivational Intervention |
| Step 2-A | Active comparator | Brief motivational intervention (BMI) Receives: Behavioral: Step 2: Brief Motivational Intervention |
| Step 2-B | Active comparator | Assessment-only control Receives: Behavioral: Alcohol Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Measured: 3, 6, and 9 months
Alcohol-related consequences
Measured: 3, 6, and 9 months
Secondary outcomes (1)
Predictors of response to treatment
Measured: 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2006
- Primary completionApr 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Brian Borsari, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Brian E. Borsari, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247182
- Sponsor's protocol ID
- NIAAABOR015518
- Other IDs
- NIH Grant R01 AA015518-01
- Status last verified
- Sep 2016
- First submitted
- 28 Oct 2005
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borsari B, O'Leary Tevyaw T, Barnett NP, Kahler CW, Monti PM. Stepped care for mandated college students: a pilot study. Am J Addict. 2007 Mar-Apr;16(2):131-7. doi: 10.1080/10550490601184498.
PubMed 17453615Borsari B, Murphy JG, Barnett NP. Predictors of alcohol use during the first year of college: implications for prevention. Addict Behav. 2007 Oct;32(10):2062-86. doi: 10.1016/j.addbeh.2007.01.017. Epub 2007 Jan 23.
PubMed 17321059Borsari B, Muellerleile P. Collateral reports in the college setting: a meta-analytic integration. Alcohol Clin Exp Res. 2009 May;33(5):826-38. doi: 10.1111/j.1530-0277.2009.00902.x. Epub 2009 Mar 6.
PubMed 19298324Hustad JT, Eaton Short E, Borsari B, Barnett NP, O'Leary Tevyaw T, Kahler CW. College alcohol citations result in modest reductions in student drinking. J Subst Abuse Treat. 2011 Apr;40(3):281-6. doi: 10.1016/j.jsat.2010.11.005. Epub 2010 Dec 28.
PubMed 21193284Barthelmes CK, Borsari B, Hustad JT, Barnett NP. Hostility in mandated students: exploratory analysis and implications for treatment. J Subst Abuse Treat. 2010 Apr;38(3):284-91. doi: 10.1016/j.jsat.2010.01.004. Epub 2010 Feb 8.
PubMed 20116962Barnett NP, Borsari B, Hustad JT, Tevyaw TO, Colby SM, Kahler CW, Monti PM. Profiles of college students mandated to alcohol intervention. J Stud Alcohol Drugs. 2008 Sep;69(5):684-94. doi: 10.15288/jsad.2008.69.684.
PubMed 18781243Kahler CW, Hustad J, Barnett NP, Strong DR, Borsari B. Validation of the 30-day version of the Brief Young Adult Alcohol Consequences Questionnaire for use in longitudinal studies. J Stud Alcohol Drugs. 2008 Jul;69(4):611-5. doi: 10.15288/jsad.2008.69.611.
PubMed 18612578Borsari B, Boyle KE, Hustad JT, Barnett NP, O'Leary Tevyaw T, Kahler CW. Drinking before drinking: pregaming and drinking games in mandated students. Addict Behav. 2007 Nov;32(11):2694-705. doi: 10.1016/j.addbeh.2007.05.003. Epub 2007 May 17.
PubMed 17574344Borsari B, Hustad JT, Mastroleo NR, Tevyaw TO, Barnett NP, Kahler CW, Short EE, Monti PM. Addressing alcohol use and problems in mandated college students: a randomized clinical trial using stepped care. J Consult Clin Psychol. 2012 Dec;80(6):1062-74. doi: 10.1037/a0029902. Epub 2012 Aug 27.
PubMed 22924334Borsari B, Short EE, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Phone-delivered brief motivational interventions for mandated college students delivered during the summer months. J Subst Abuse Treat. 2014 May-Jun;46(5):592-6. doi: 10.1016/j.jsat.2014.01.001. Epub 2014 Jan 13.
PubMed 24512944Teeters JB, Borsari B, Martens MP, Murphy JG. Brief Motivational Interventions Are Associated With Reductions in Alcohol-Impaired Driving Among College Drinkers. J Stud Alcohol Drugs. 2015 Sep;76(5):700-9. doi: 10.15288/jsad.2015.76.700.
PubMed 26402350Yurasek AM, Borsari B, Magill M, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Descriptive norms and expectancies as mediators of a brief motivational intervention for mandated college students receiving stepped care for alcohol use. Psychol Addict Behav. 2015 Dec;29(4):1003-11. doi: 10.1037/adb0000092. Epub 2015 Jun 22.
PubMed 26098125Borsari B, Magill M, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Eaton E, Monti PM. Mandated college students' response to sequentially administered alcohol interventions in a randomized clinical trial using stepped care. J Consult Clin Psychol. 2016 Feb;84(2):103-12. doi: 10.1037/a0039800. Epub 2015 Oct 12.
PubMed 26460571Fernandez 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 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Mandated College Students
- ClinicalTrials.gov ID
- NCT00247182
- Acronym / sponsor ID
- NIAAABOR015518
- Conditions
- Alcohol Use
- Keywords
- Stepped Care, Brief Motivational Intervention, Minimal Intervention, Treatment response, College Students
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Nov 2005 (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 provides stepped care to college students mandated for alcohol-related offenses. Students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. Students who continue to drink in a risky manner are provided with a more intensive, hour-long brief motivational interview. By providing more intensive treatment to the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol programs.
Detailed description
Colleges and universities have seen a large increase in the number of students referred to the administration for the violation of alcohol policies. However, research indicates that the majority of mandated students may not require extensive treatment. Stepped care assigns individuals to different levels of care according to their response to treatment. Encouraging research indicates that minimal interventions and BMIs may reduce heavy drinking in mandated college students. Thus, implementing stepped care using these interventions could maximize treatment efficiency and reduce the demands on campus alcohol programs.
Participants will be students mandated to attend an alcohol program at a northeastern private university. All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later, and those continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. The three groups will be compared on two outcome measures: frequency of binge drinking episodes and alcohol-related problems in the past 30 days. Predictors of treatment response (readiness to change, alcohol expectancies, age of first drink, sensation seeking, descriptive norms, and reaction to the referral) will also be evaluated for both steps of the intervention. Research findings will assist college alcohol programs in determining the most effective and efficient allocation of their limited resources in treating mandated students. The long-term objectives of this research are to inform preventive intervention research about the utility and cost-effectiveness of stepped-care approaches and to identify individual and situational factors that qualify these effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Step 1 | Other | Behavioral: Step 1: Minimal Intervention, Behavioral: Step 2: Brief Motivational InterventionMinimal Intervention |
| Step 2-A | Active comparator | Behavioral: Step 2: Brief Motivational InterventionBrief motivational intervention (BMI) |
| Step 2-B | Active comparator | Behavioral: Alcohol AssessmentAssessment-only control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female students 18 years of age or older.
- Participants will have signed a witnessed informed consent.
- Participants will have been referred for an alcohol-related offense
Key exclusion criteria (2 listed)
- Participants who meet current DSM-IV criteria for substance use disorder
- Participants who are currently in treatment for substance use.
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 |
|---|---|---|
| Step 1: Minimal InterventionAll participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later. All students will complete 3, 6, and 9 month follow-up assessments | Behavioural | Step 1 |
| Step 2: Brief Motivational InterventionParticipants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. | Behavioural | Step 1, Step 2-A |
| Alcohol AssessmentParticipants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. | Behavioural | Step 2-B |
Primary outcome
Alcohol consumption
Time frame: 3, 6, and 9 months
Alcohol-related consequences
Time frame: 3, 6, and 9 months
1 secondary outcome
Predictors of response to treatment
Time frame: 3, 6, and 9 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 21 Sep 2016.
- Background: PubMed 17453615Borsari B, O'Leary Tevyaw T, Barnett NP, Kahler CW, Monti PM. Stepped care for mandated college students: a pilot study. Am J Addict. 2007 Mar-Apr;16(2):131-7. doi: 10.1080/10550490601184498.
- Background: PubMed 17321059Borsari B, Murphy JG, Barnett NP. Predictors of alcohol use during the first year of college: implications for prevention. Addict Behav. 2007 Oct;32(10):2062-86. doi: 10.1016/j.addbeh.2007.01.017. Epub 2007 Jan 23.
- Background: PubMed 19298324Borsari B, Muellerleile P. Collateral reports in the college setting: a meta-analytic integration. Alcohol Clin Exp Res. 2009 May;33(5):826-38. doi: 10.1111/j.1530-0277.2009.00902.x. Epub 2009 Mar 6.
- Results publication: PubMed 21193284Hustad JT, Eaton Short E, Borsari B, Barnett NP, O'Leary Tevyaw T, Kahler CW. College alcohol citations result in modest reductions in student drinking. J Subst Abuse Treat. 2011 Apr;40(3):281-6. doi: 10.1016/j.jsat.2010.11.005. Epub 2010 Dec 28.
- Results publication: PubMed 20116962Barthelmes CK, Borsari B, Hustad JT, Barnett NP. Hostility in mandated students: exploratory analysis and implications for treatment. J Subst Abuse Treat. 2010 Apr;38(3):284-91. doi: 10.1016/j.jsat.2010.01.004. Epub 2010 Feb 8.
- Results publication: PubMed 18781243Barnett NP, Borsari B, Hustad JT, Tevyaw TO, Colby SM, Kahler CW, Monti PM. Profiles of college students mandated to alcohol intervention. J Stud Alcohol Drugs. 2008 Sep;69(5):684-94. doi: 10.15288/jsad.2008.69.684.
- Results publication: PubMed 18612578Kahler CW, Hustad J, Barnett NP, Strong DR, Borsari B. Validation of the 30-day version of the Brief Young Adult Alcohol Consequences Questionnaire for use in longitudinal studies. J Stud Alcohol Drugs. 2008 Jul;69(4):611-5. doi: 10.15288/jsad.2008.69.611.
- Results publication: PubMed 17574344Borsari B, Boyle KE, Hustad JT, Barnett NP, O'Leary Tevyaw T, Kahler CW. Drinking before drinking: pregaming and drinking games in mandated students. Addict Behav. 2007 Nov;32(11):2694-705. doi: 10.1016/j.addbeh.2007.05.003. Epub 2007 May 17.
- Results publication: PubMed 22924334Borsari B, Hustad JT, Mastroleo NR, Tevyaw TO, Barnett NP, Kahler CW, Short EE, Monti PM. Addressing alcohol use and problems in mandated college students: a randomized clinical trial using stepped care. J Consult Clin Psychol. 2012 Dec;80(6):1062-74. doi: 10.1037/a0029902. Epub 2012 Aug 27.
- Results publication: PubMed 24512944Borsari B, Short EE, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Phone-delivered brief motivational interventions for mandated college students delivered during the summer months. J Subst Abuse Treat. 2014 May-Jun;46(5):592-6. doi: 10.1016/j.jsat.2014.01.001. Epub 2014 Jan 13.
- Results publication: PubMed 26402350Teeters JB, Borsari B, Martens MP, Murphy JG. Brief Motivational Interventions Are Associated With Reductions in Alcohol-Impaired Driving Among College Drinkers. J Stud Alcohol Drugs. 2015 Sep;76(5):700-9. doi: 10.15288/jsad.2015.76.700.
- Results publication: PubMed 26098125Yurasek AM, Borsari B, Magill M, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Descriptive norms and expectancies as mediators of a brief motivational intervention for mandated college students receiving stepped care for alcohol use. Psychol Addict Behav. 2015 Dec;29(4):1003-11. doi: 10.1037/adb0000092. Epub 2015 Jun 22.
- Related InfoLink 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.
Brian E. Borsari, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Step 1: Minimal Intervention, Step 2: Brief Motivational Intervention and Alcohol Assessment in people with Alcohol Use, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 3 inclusion and 2 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 21 Sep 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Alcohol consumption (time frame: 3, 6, and 9 months). 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 NCT00247182, which also lists 14 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 21 Sep 2016.