College Student DrinkingNCT03930524
Adaptive Preventive Intervention for College Alcohol Use
A study testing Personalized Normative Feedback (PNF), Self-Monitoring (SM) and Web-BASICS in people with College Student Drinking, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- College Student Drinking
- What is being tested?
- Personalized Normative Feedback (PNF), Self-Monitoring (SM) and Web-BASICS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 891 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Incoming college students aged 18-21 at the University of Minnesota will be eligible and randomly selected for participation.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55415
About this study
Official title: An Adaptive Preventive Intervention to Optimize the Transition From Universal to Indicated Resources for College Student Alcohol Use
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.
Read the 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 this 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 M-bridge). A sequential multiple assignment randomized trial (SMART) design 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 M-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.
- Conditions
- College Student Drinking
- Being tested
- Personalized Normative Feedback (PNF), Self-Monitoring (SM), Web-BASICS, Health Promotion Consultation, M-Bridge Online Health Coach
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative Feedback (PNF)Behavioural
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.
Self-Monitoring (SM)Behavioural
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)
Web-BASICSBehavioural
Also called Brief Alcohol Screening Intervention for College Students
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.
Health Promotion ConsultationBehavioural
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.
M-Bridge Online Health CoachBehavioural
Also called Electronic Bridge to Mental Health Services (eBridge)
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).
| Study group | Role | What they receive |
|---|---|---|
| Assessment Only | No intervention | Control |
| Early-college Universal | Experimental | 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. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM) |
| Early-college No Coach (automated email) | Experimental | 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. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM); Behavioral: Web-BASICS; Behavioral: Health Promotion Consultation |
| Early-college Coach | Experimental | 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 wellbeing, with a particular emphasis on alcohol use. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM); Behavioral: Web-BASICS; Behavioral: Health Promotion Consultation; Behavioral: M-Bridge Online Health Coach |
| Later-college Universal | Experimental | 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. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM) |
| Later-college No Coach (automated email) | Experimental | 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 wellbeing, with a particular emphasis on alcohol use. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM); Behavioral: Web-BASICS; Behavioral: Health Promotion Consultation |
| Later-college Coach | Experimental | 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 wellbeing, with a particular emphasis on alcohol use. Receives: Behavioral: Personalized Normative Feedback (PNF); Behavioral: Self-Monitoring (SM); Behavioral: Web-BASICS; Behavioral: Health Promotion Consultation; Behavioral: M-Bridge Online Health Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Drinking
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/).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start31 Jul 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for College Student DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial
- Masking
- None (open label)
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Michigan, University of Washington
- Responsible party
- Sponsor
- Investigators
- Megan Patrick, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930524
- Sponsor's protocol ID
- STUDY00006421
- Other IDs
- R01AA026574
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2019
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
PubMed 27663578Labrie JW, Lewis MA, Atkins DC, Neighbors C, Zheng C, Kenney SR, Napper LE, Walter T, Kilmer JR, Hummer JF, Grossbard J, Ghaidarov TM, Desai S, Lee CM, Larimer ME. RCT of web-based personalized normative feedback for college drinking prevention: are typical student norms good enough? J Consult Clin Psychol. 2013 Dec;81(6):1074-86. doi: 10.1037/a0034087. Epub 2013 Aug 12.
PubMed 23937346Lee CM, Neighbors C, Lewis MA, Kaysen D, Mittmann A, Geisner IM, Atkins DC, Zheng C, Garberson LA, Kilmer JR, Larimer ME. Randomized controlled trial of a Spring Break intervention to reduce high-risk drinking. J Consult Clin Psychol. 2014 Apr;82(2):189-201. doi: 10.1037/a0035743. Epub 2014 Feb 3.
PubMed 24491072Patrick ME, Boatman JA, Morrell N, Wagner AC, Lyden GR, Nahum-Shani I, King CA, Bonar EE, Lee CM, Larimer ME, Vock DM, Almirall D. A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction. Contemp Clin Trials. 2020 Sep;96:106089. doi: 10.1016/j.cct.2020.106089. Epub 2020 Jul 25.
PubMed 32717350Bonar EE, Parks MJ, Gunlicks-Stoessel M, Lyden GR, Mehus CJ, Morrell N, Patrick ME. Binge drinking before and after a COVID-19 campus closure among first-year college students. Addict Behav. 2021 Jul;118:106879. doi: 10.1016/j.addbeh.2021.106879. Epub 2021 Feb 23.
PubMed 33706071Mehus CJ, Lyden GR, Bonar EE, Gunlicks-Stoessel M, Morrell N, Parks MJ, Wagner AC, Patrick ME. Association between COVID-19-related loneliness or worry and symptoms of anxiety and depression among first-year college students. J Am Coll Health. 2023 Jul;71(5):1332-1337. doi: 10.1080/07448481.2021.1942009. Epub 2021 Jul 9.
PubMed 34242555Lyden GR, Vock DM, Sur A, Morrell N, Lee CM, Patrick ME. Deeply Tailored Adaptive Interventions to Reduce College Student Drinking: a Real-World Application of Q-Learning for SMART Studies. Prev Sci. 2022 Aug;23(6):1053-1064. doi: 10.1007/s11121-022-01371-7. Epub 2022 May 11.
PubMed 35543888Carpenter SM, Yap J, Patrick ME, Morrell N, Dziak JJ, Almirall D, Yoon C, Nahum-Shani I. Self-relevant appeals to engage in self-monitoring of alcohol use: A microrandomized trial. Psychol Addict Behav. 2023 May;37(3):434-446. doi: 10.1037/adb0000855. Epub 2022 Jul 14.
PubMed 35834200Patrick ME, Lyden GR, Morrell N, Mehus CJ, Gunlicks-Stoessel M, Lee CM, King CA, Bonar EE, Nahum-Shani I, Almirall D, Larimer ME, Vock DM. Main outcomes of M-bridge: A sequential multiple assignment randomized trial (SMART) for developing an adaptive preventive intervention for college drinking. J Consult Clin Psychol. 2021 Jul;89(7):601-614. doi: 10.1037/ccp0000663.
PubMed 34383533
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Preventive Intervention to Optimize the Transition From Universal to Indicated Resources for College Student Alcohol Use
- ClinicalTrials.gov ID
- NCT03930524
- Acronym / sponsor ID
- STUDY00006421
- Conditions
- College Student Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Michigan, University of Washington
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 this 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 M-bridge). A sequential multiple assignment randomized trial (SMART) design 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 M-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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Sequential Multiple Assignment Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Assessment Only | No intervention | –Control |
| Early-college Universal | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM)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. |
| Early-college No Coach (automated email) | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM), Behavioral: Web-BASICS, Behavioral: Health Promotion ConsultationStudents 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. |
| Early-college Coach | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM), Behavioral: Web-BASICS, Behavioral: Health Promotion Consultation, Behavioral: M-Bridge Online Health CoachStudents 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 wellbeing, with a particular emphasis on alcohol use. |
| Later-college Universal | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM)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. |
| Later-college No Coach (automated email) | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM), Behavioral: Web-BASICS, Behavioral: Health Promotion ConsultationStudents 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 wellbeing, with a particular emphasis on alcohol use. |
| Later-college Coach | Experimental | Behavioral: Personalized Normative Feedback (PNF), Behavioral: Self-Monitoring (SM), Behavioral: Web-BASICS, Behavioral: Health Promotion Consultation, Behavioral: M-Bridge Online Health CoachStudents 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 wellbeing, with a particular emphasis on alcohol use. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Incoming college students aged 18-21 at the University of Minnesota will be eligible and randomly selected for participation.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 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. | Behavioural | Early-college Coach, Early-college No Coach (automated email), Early-college Universal, Later-college Coach, Later-college No Coach (automated email), Later-college Universal |
| 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) | Behavioural | Early-college Coach, Early-college No Coach (automated email), Early-college Universal, Later-college Coach, Later-college No Coach (automated email), Later-college Universal |
| Web-BASICSAlso: Brief Alcohol Screening Intervention for College StudentsWeb-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. | Behavioural | Early-college Coach, Early-college No Coach (automated email), Later-college Coach, Later-college No Coach (automated email) |
| Health Promotion ConsultationA 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. | Behavioural | Early-college Coach, Early-college No Coach (automated email), Later-college Coach, Later-college No Coach (automated email) |
| M-Bridge Online Health CoachAlso: Electronic Bridge to Mental Health Services (eBridge)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). | Behavioural | Early-college Coach, Later-college Coach |
Primary outcome
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/).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27663578Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
- Background: PubMed 23937346Labrie JW, Lewis MA, Atkins DC, Neighbors C, Zheng C, Kenney SR, Napper LE, Walter T, Kilmer JR, Hummer JF, Grossbard J, Ghaidarov TM, Desai S, Lee CM, Larimer ME. RCT of web-based personalized normative feedback for college drinking prevention: are typical student norms good enough? J Consult Clin Psychol. 2013 Dec;81(6):1074-86. doi: 10.1037/a0034087. Epub 2013 Aug 12.
- Background: PubMed 24491072Lee CM, Neighbors C, Lewis MA, Kaysen D, Mittmann A, Geisner IM, Atkins DC, Zheng C, Garberson LA, Kilmer JR, Larimer ME. Randomized controlled trial of a Spring Break intervention to reduce high-risk drinking. J Consult Clin Psychol. 2014 Apr;82(2):189-201. doi: 10.1037/a0035743. Epub 2014 Feb 3.
- Background: PubMed 32717350Patrick ME, Boatman JA, Morrell N, Wagner AC, Lyden GR, Nahum-Shani I, King CA, Bonar EE, Lee CM, Larimer ME, Vock DM, Almirall D. A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction. Contemp Clin Trials. 2020 Sep;96:106089. doi: 10.1016/j.cct.2020.106089. Epub 2020 Jul 25.
- Background: PubMed 33706071Bonar EE, Parks MJ, Gunlicks-Stoessel M, Lyden GR, Mehus CJ, Morrell N, Patrick ME. Binge drinking before and after a COVID-19 campus closure among first-year college students. Addict Behav. 2021 Jul;118:106879. doi: 10.1016/j.addbeh.2021.106879. Epub 2021 Feb 23.
- Background: PubMed 34242555Mehus CJ, Lyden GR, Bonar EE, Gunlicks-Stoessel M, Morrell N, Parks MJ, Wagner AC, Patrick ME. Association between COVID-19-related loneliness or worry and symptoms of anxiety and depression among first-year college students. J Am Coll Health. 2023 Jul;71(5):1332-1337. doi: 10.1080/07448481.2021.1942009. Epub 2021 Jul 9.
- Background: PubMed 35543888Lyden GR, Vock DM, Sur A, Morrell N, Lee CM, Patrick ME. Deeply Tailored Adaptive Interventions to Reduce College Student Drinking: a Real-World Application of Q-Learning for SMART Studies. Prev Sci. 2022 Aug;23(6):1053-1064. doi: 10.1007/s11121-022-01371-7. Epub 2022 May 11.
- Background: PubMed 35834200Carpenter SM, Yap J, Patrick ME, Morrell N, Dziak JJ, Almirall D, Yoon C, Nahum-Shani I. Self-relevant appeals to engage in self-monitoring of alcohol use: A microrandomized trial. Psychol Addict Behav. 2023 May;37(3):434-446. doi: 10.1037/adb0000855. Epub 2022 Jul 14.
- Results publication: PubMed 34383533Patrick ME, Lyden GR, Morrell N, Mehus CJ, Gunlicks-Stoessel M, Lee CM, King CA, Bonar EE, Nahum-Shani I, Almirall D, Larimer ME, Vock DM. Main outcomes of M-bridge: A sequential multiple assignment randomized trial (SMART) for developing an adaptive preventive intervention for college drinking. J Consult Clin Psychol. 2021 Jul;89(7):601-614. doi: 10.1037/ccp0000663.
- Individual participant dataSharing planned: No
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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.
Megan Patrick, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Normative Feedback (PNF), Self-Monitoring (SM) and Web-BASICS in people with College Student Drinking, run by University of Minnesota 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 1 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 12 Apr 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Binge Drinking (time frame: 3 months). 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 NCT03930524, which also lists 9 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 12 Apr 2023.