Adaptive Preventive Intervention for College Alcohol Use
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03930524 |
Recruitment Status :
Completed
First Posted : April 29, 2019
Last Update Posted : August 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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College Student Drinking | Behavioral: Personalized Normative Feedback (PNF) Behavioral: M-Bridge Online Health Coach Behavioral: Web-BASICS Behavioral: Health Promotion Consultation Behavioral: Self-Monitoring (SM) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 891 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Sequential Multiple Assignment Randomized Trial |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | An Adaptive Preventive Intervention to Optimize the Transition From Universal to Indicated Resources for College Student Alcohol Use |
Actual Study Start Date : | July 31, 2019 |
Actual Primary Completion Date : | August 1, 2022 |
Actual Study Completion Date : | August 1, 2022 |
Arm | Intervention/treatment |
---|---|
No Intervention: Assessment Only
Control
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Experimental: Early-college Universal
Prior to beginning their first semester of college, incoming students will receive personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring surveys over the course of the semester.
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Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
Experimental: Early-college No Coach (automated email)
Students from the early-college universal arm, who flag on one of the self monitoring surveys are invited to engage in a web-based resource or in-person consultation to improve well-being, with a particular emphasis on alcohol use.
|
Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: Web-BASICS Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Other Name: Brief Alcohol Screening Intervention for College Students Behavioral: Health Promotion Consultation A health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
Experimental: Early-college Coach
Students from the early-college universal arm, who flag on one of the self monitoring surveys are invited to correspond with an online health coach who will use motivational interviewing strategies to encourage engagement in a web-based resource or in-person consultation to improve well-being, with a particular emphasis on alcohol use.
|
Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: M-Bridge Online Health Coach A health coach will correspond with students via a secure online chat platform, utilizing motivational interviewing strategies to encourage students to consider their values and goals, the possibility of behavior change, and available services. The goal of the dialogue is to motivate the student to access alcohol use interventions (Web-BASICS or an in-person health promotion consultation).
Other Name: Electronic Bridge to Mental Health Services (eBridge) Behavioral: Web-BASICS Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Other Name: Brief Alcohol Screening Intervention for College Students Behavioral: Health Promotion Consultation A health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
Experimental: Later-college Universal
After beginning their first semester of college, students will receive personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring surveys over the course of the semester.
|
Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
Experimental: Later-college No Coach (automated email)
Students from the later-college universal arm, who flag on one of the self monitoring surveys are invited to engage in a web-based resource or in-person consultation to improve well-being, with a particular emphasis on alcohol use.
|
Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: Web-BASICS Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Other Name: Brief Alcohol Screening Intervention for College Students Behavioral: Health Promotion Consultation A health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
Experimental: Later-college Coach
Students from the later-college universal arm, who flag on one of the self monitoring surveys are invited to correspond with an online health coach who will use motivational interviewing strategies to encourage engagement in a web-based resource or in-person consultation to improve well-being, with a particular emphasis on alcohol use.
|
Behavioral: Personalized Normative Feedback (PNF)
Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group. Behavioral: M-Bridge Online Health Coach A health coach will correspond with students via a secure online chat platform, utilizing motivational interviewing strategies to encourage students to consider their values and goals, the possibility of behavior change, and available services. The goal of the dialogue is to motivate the student to access alcohol use interventions (Web-BASICS or an in-person health promotion consultation).
Other Name: Electronic Bridge to Mental Health Services (eBridge) Behavioral: Web-BASICS Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Other Name: Brief Alcohol Screening Intervention for College Students Behavioral: Health Promotion Consultation A health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions. Behavioral: Self-Monitoring (SM) Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016) |
- Binge Drinking [ Time Frame: 3 months ]Respondents are asked about the frequency of consuming 4/5+ drinks within a two-hour period in the past 30 days. Questions are based on NIAAA recommended alcohol questions (https://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions) and Monitoring the Future survey items (http://www.monitoringthefuture.org/).
- Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) [ Time Frame: 3 months ]Respondents are asked 24 items derived from the 48-item Young Adult Alcohol Consequences Questionnaire. The Brief Young Adult Consequences Questionnaire (B-YAACQ; Read et al., 2006) has items that tap the full range of the alcohol problems continuum from signs of excessive drinking to symptoms consistent with alcohol abuse and alcohol dependence.
- Utilization of Health Services Survey [ Time Frame: 3 months ]Respondents are asked about their utilization of various health services (e.g. healthcare clinics, therapy, support groups, self-help resources, etc.) in the last 3 months, including when they started, if they are currently utilizing the service/resource, and how helpful it has been.
- Maximum Number of Drinks [ Time Frame: 3 months ]Respondents are asked about the maximum number of drinks consumed within a 24-hour period in the past 30 days. Question is based on NIAAA recommended alcohol questions (https://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 21 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Incoming college students aged 18-21 at the University of Minnesota will be eligible and randomly selected for participation.
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930524
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55415 |
Principal Investigator: | Megan Patrick, PhD | University of Michigan |
Publications of Results:
Other Publications:
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT03930524 |
Other Study ID Numbers: |
STUDY00006421 R01AA026574 ( U.S. NIH Grant/Contract ) |
First Posted: | April 29, 2019 Key Record Dates |
Last Update Posted: | August 9, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alcohol Drinking in College Alcohol Drinking Drinking Behavior |