Clinical trial NCT04030325: Motivating Campus Change Study
Official title: Motivating Campus Change Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drinking Behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-23
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study evaluates the relative merit of a multi-component PFI presented in the traditional simultaneous delivery (i.e., all components at once) versus a sequential format, wherein individual PFI components are delivered one at a time over several weeks to minimize time and attention demands for each component.

Detailed description: This study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among college students. The purpose of this research is to determine optimal configuration of PFIs to take advantage of the clarity and initial impact of single-component PFIs and greater effect size and duration of personalized multi-component PFIs. The Investigators seek to increase and evaluate engagement with the PFI and text-message materials and boost innovation of both content and process of the intervention. In addition to PFI content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of PFI effects impacted by fluctuations in drinking associated with high-risk events. Prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., Spring Break), but have not targeted both general and event-specific drinking together. These enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students.

Eligibility criteria: Inclusion Criteria:

* at least 1 heavy episodic drinking episode in the past month
* at least 3 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past 3 months for cohort 1
* at least 2 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past month for cohort 2 - 5
* Indicate they own a cell phone with text message capabilities and consent to receiving text messages

Exclusion Criteria:

* Doesn't meet inclusion criteria
* Unwillingness to participate
* Failure to provide consent
* Plan to travel internationally in the next 12 months (for intervention text purposes)

Primary outcomes:
measure: Change from Baseline Alcohol Use at 6 months
timeFrame: 6 months of assessment
measure: Change from Baseline Alcohol Use at 12 months
timeFrame: 12 months of assessment
measure: Change from Baseline Alcohol Use at 18 months
timeFrame: 18 months of assessment
measure: Change from Baseline Alcohol Use at 24 months
timeFrame: 24 months of assessment
Secondary outcomes:
measure: Alcohol Use on New Years Eve
timeFrame: 2 days
measure: Alcohol Use during Spring Break
timeFrame: 10 days
measure: Alcohol Use on 4th of July
timeFrame: 4 days
measure: Alcohol Use on Halloween
timeFrame: 4 days
measure: Alcohol Use during Birthday
timeFrame: 10 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: The Center for the Study of Health and Risk Behaviors
state: Washington
Study officials:
affiliation: University of Washington
name: Mary E Larimer, PhD
role: PRINCIPAL_INVESTIGATOR
References: