NCT03930524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
891

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

April 18, 2019

Results QC Date

December 5, 2022

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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/).

    3 months

Study Arms (7)

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.

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.

Behavioral: Personalized Normative Feedback (PNF)Behavioral: Self-Monitoring (SM)Behavioral: Web-BASICSBehavioral: 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.

Behavioral: Personalized Normative Feedback (PNF)Behavioral: Self-Monitoring (SM)Behavioral: Web-BASICSBehavioral: Health Promotion ConsultationBehavioral: 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.

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.

Behavioral: Personalized Normative Feedback (PNF)Behavioral: Self-Monitoring (SM)Behavioral: Web-BASICSBehavioral: 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.

Behavioral: Personalized Normative Feedback (PNF)Behavioral: Self-Monitoring (SM)Behavioral: Web-BASICSBehavioral: Health Promotion ConsultationBehavioral: M-Bridge Online Health Coach

Interventions

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.

Early-college CoachEarly-college No Coach (automated email)Early-college UniversalLater-college CoachLater-college No Coach (automated email)Later-college Universal

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)

Early-college CoachEarly-college No Coach (automated email)Early-college UniversalLater-college CoachLater-college No Coach (automated email)Later-college Universal
Web-BASICSBEHAVIORAL

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.

Also known as: Brief Alcohol Screening Intervention for College Students
Early-college CoachEarly-college No Coach (automated email)Later-college CoachLater-college No Coach (automated email)

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.

Early-college CoachEarly-college No Coach (automated email)Later-college CoachLater-college No Coach (automated email)

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).

Also known as: Electronic Bridge to Mental Health Services (eBridge)
Early-college CoachLater-college Coach

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (9)

  • 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.

    PMID: 27663578BACKGROUND
  • Labrie 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.

    PMID: 23937346BACKGROUND
  • Lee 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.

    PMID: 24491072BACKGROUND
  • Patrick 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.

    PMID: 32717350BACKGROUND
  • Bonar 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.

    PMID: 33706071BACKGROUND
  • Mehus 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.

    PMID: 34242555BACKGROUND
  • Lyden 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.

    PMID: 35543888BACKGROUND
  • Carpenter 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.

    PMID: 35834200BACKGROUND
  • Patrick 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.

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

Blood Glucose Self-MonitoringEthanolMass Screening

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesAlcoholsOrganic ChemicalsHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Limitations and Caveats

Limitations of the SMART are specified on page 13 of the "Main Outcomes of M-bridge" manuscript.

Results Point of Contact

Title
Dr. Megan Patrick
Organization
University of Michigan

Study Officials

  • Megan Patrick, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Sequential Multiple Assignment Randomized Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 29, 2019

Study Start

July 31, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

April 12, 2023

Results First Posted

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations