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Adaptive Preventive Intervention for College Alcohol Use

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ClinicalTrials.gov Identifier: NCT03930524
Recruitment Status : Active, not recruiting
First Posted : April 29, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Michigan
University of Washington
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE July 31, 2019
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
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/).
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Daily Drinking Questionnaire (DDQ-R) [ Time Frame: 3 months ]
  • Alcohol Frequency and Quantity [ 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/).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) [ Time Frame: 3 months ]
  • Utilization of Health Services [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adaptive Preventive Intervention for College Alcohol Use
Official Title  ICMJE An Adaptive Preventive Intervention to Optimize the Transition From Universal to Indicated Resources for College Student Alcohol Use
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Sequential Multiple Assignment Randomized Trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE College Student Drinking
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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 4 self-monitoring surveys over the course of the semester.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: Self-Monitoring (SM)
  • 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.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: Web-BASICS
    • Behavioral: Health Promotion Consultation
    • Behavioral: Self-Monitoring (SM)
  • 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.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: M-Bridge Online Health Coach
    • Behavioral: Web-BASICS
    • Behavioral: Health Promotion Consultation
    • Behavioral: Self-Monitoring (SM)
  • 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.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: Self-Monitoring (SM)
  • 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.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: Web-BASICS
    • Behavioral: Health Promotion Consultation
    • Behavioral: Self-Monitoring (SM)
  • 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.
    Interventions:
    • Behavioral: Personalized Normative Feedback (PNF)
    • Behavioral: M-Bridge Online Health Coach
    • Behavioral: Web-BASICS
    • Behavioral: Health Promotion Consultation
    • Behavioral: Self-Monitoring (SM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 9, 2019)
891
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
700
Estimated Study Completion Date  ICMJE September 25, 2020
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 21 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930524
Other Study ID Numbers  ICMJE STUDY00006421
R01AA026574 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Michigan
  • University of Washington
Investigators  ICMJE
Principal Investigator: Megan Patrick, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP