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Adaptive Preventive Intervention for College Alcohol Use

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ClinicalTrials.gov Identifier: NCT03930524
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Michigan
University of Washington
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This research project is designed to promote health among first-year college students by implementing an adaptive sequence of preventive intervention strategies to motivate heavy-drinking college students to access existing resources in order to reduce high-risk alcohol use and negative consequences. If found efficacious, the adaptive preventive intervention (API) has the potential to reduce both the acute negative health consequences (e.g., injury, alcohol poisoning) and long-term health consequences (e.g., alcohol use disorders) of young adult alcohol use, while seeking to leverage technology in order to use campus resources in the most efficient way possible.

Condition or disease Intervention/treatment Phase
College Student Drinking Behavioral: Personalized Normative Feedback (PNF) Behavioral: Mobile Bridge Online Health Coach Behavioral: Web-BASICS Behavioral: Health Promotion Consultation Behavioral: Self-Monitoring (SM) Not Applicable

Detailed Description:
College student alcohol use and associated negative consequences are public health problems. In particular, first-year students transitioning to college are at increased risk. Scarce intervention resources must be used as wisely as possible to address these concerns. One way to address heavy drinking while conserving resources is to first utilize universal interventions, identify students at high risk who do not respond well, and then motivate them to engage in indicated intervention. This approach to prevention is 'adaptive' because information about the student in the course of the intervention (e.g., response status) is used to determine whether more resources should be invested to motivate the student to transition to indicated services. The purpose of the proposed project is to implement adaptive preventive intervention (API) that employs cost-effective, technology-based brief interventions to do the following. First, provide a universal personalized normative feedback (PNF) intervention followed by student self-monitoring (SM). Second, motivate students who continue to drink heavily (i.e., 2+ reports of 4/5+ drinks for women/men, or 1 report of 8/10+ drinks for women/men) to transition to additional intervention resources. To optimize the efficacy of this intervention, we will investigate the best timing for delivering the initial universal PNF+SM intervention (i.e., as an inoculation before moving to college vs. once they are experiencing the college context during their first semester). Additionally, we will examine how best to motivate heavy-drinking students to pursue indicated intervention (i.e., via automated emails vs. online interaction with a personal health coach using mBridge). A sequential multiple assignment randomized trial (SMART) design (N=700) will be used to address these questions. College students will be randomized to receive PNF either before college begins (2 weeks before classes start) or during the beginning of the first semester (about 3 weeks after they arrive on campus), followed by SM every two weeks during the first semester; these SM assessments will be used to identify heavy-drinking students who remain at risk. Once heavy drinking is identified, the student will be re-randomized to either an automated email or Mobile Bridge health coach to offer indicated intervention resources. The specific aims are to examine: (1) the efficacy of the API compared to an assessment-only control, (2) whether the API can be optimized by altering the timing of the universal intervention and/or the type of message to motivate seeking indicated intervention, and (3) moderators of these effects (e.g., pre-college drinking intentions, high-intensity [compared to binge] drinking during the start of college). Frequency of heavy drinking, alcohol-related consequences, and health services utilization will be assessed prior to the start of classes, and at each follow-up point (the end of the semester, the end of the year, and the following fall). The API to be refined through this project will offer a novel strategy for mitigating both the acute negative health consequences (e.g., injury, alcohol poisoning) and long-term health consequences (e.g., alcohol use disorders) of young adult alcohol use.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
No Intervention: Assessment Only
Control
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 5 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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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
Students from the early-college universal arm, who flag on one of the 5 self monitoring surveys are invited to engage in a web-based or in-person skills training to improve well-being.
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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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 the web in studies conducted by Drs. Larimer and Lee (see preliminary studies; 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 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 5 self monitoring surveys are invited to correspond with a health coach who will use motivational interviewing strategies to encourage engagement in a web-based or in-person skills training to improve well-being.
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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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: Mobile 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 the web in studies conducted by Drs. Larimer and Lee (see preliminary studies; 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 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 5 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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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
Students from the later-college universal arm, who flag on one of the 5 self monitoring surveys are invited to engage in a web-based or in-person skills training to improve well-being.
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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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 the web in studies conducted by Drs. Larimer and Lee (see preliminary studies; 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 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 5 self monitoring surveys are invited to correspond with a health coach who will use motivational interviewing strategies to encourage engagement in a web-based or in-person skills training to improve well-being.
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 appropriate feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on 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. All 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: Mobile 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 the web in studies conducted by Drs. Larimer and Lee (see preliminary studies; 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 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)




Primary Outcome Measures :
  1. Daily Drinking Questionnaire (DDQ-R) [ Time Frame: 3 months ]
  2. Alcohol Frequency and Quantity Survey [ Time Frame: 3 months ]
    Respondents are asked about the frequency and quantity of drinking during the past 30 days, and then last two weeks. Questions are based on Monitoring the Future survey items (http://www.monitoringthefuture.org/).


Secondary Outcome Measures :
  1. Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) [ Time Frame: 3 months ]
  2. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Incoming college students aged 18-21 at the University of Minnesota will be eligible and randomly selected for participation.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Megan Patrick, PhD 612-624-8063 mpatrick@umn.edu

Locations
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United States, Minnesota
Institute for Translational Research in Children's Mental Health Not yet recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Nicole Morrell, MEd    612-624-2600    morre006@umn.edu   
Contact: Anna Wagner, BS       wagn0479@umn.edu   
Principal Investigator: Megan Patrick, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Michigan
University of Washington
Investigators
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Principal Investigator: Megan Patrick, PhD University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Publications:
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03930524     History of Changes
Other Study ID Numbers: R01AA026574 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alcohol Drinking in College
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs