Clinical trial NCT03930524: Adaptive Preventive Intervention for College Alcohol Use
Official title: An Adaptive Preventive Intervention to Optimize the Transition From Universal to Indicated Resources for College Student Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: College Student Drinking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Michigan
name: University of Washington
First posted: 2019-04-29
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Binge Drinking
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Michigan
name: Megan Patrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.