Clinical trial NCT05616247: Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing College Student Alcohol Use and Harms
Official title: Immediate and Long-term Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing Adverse Alcohol Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Use, Underage
Harmful; Use, Alcohol
Keywords: College Alcohol Use
Expectancies
Expectancy Challenge
Expectancy Challenge Alcohol Literacy Curriculum
Alcohol-Related Harms
Underage Alcohol Use
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current project uses a web-based program called the Expectancy Challenge Alcohol Literacy Curriculum (ECALC) to reduce alcohol use and associated harms among college students. Participants complete the interactive program in 50 minutes, and then provide daily, real-time data on expectancies and alcohol use for 3 weeks after intervention, and again for one week at 13 and 25 weeks after intervention. One group will also receive biweekly boosters delivered via smart phone to assess their impact on intervention decay over time. It is hypothesized that ECALC effects may decay over time, and that biweekly boosters will prevent this decay. Access to the ECALC is available on request from the principal investigator.

Detailed description: The Expectancy Challenge Alcohol Literacy Curriculum (ECALC) is a 50-minute interactive program, and the only non-experiential expectancy challenge that has been successful in significantly reducing alcohol use and harms among college students. In studies focused on mandated students, fraternity and sorority members, and first year college students, ECALC has produced larger effect sizes than experiential expectancy challenge and all widely used programs. ECALC outcome studies have thus far been limited to four weeks, but the design of ECALC suggests that effects might be sustained for much longer. The primary aim of the proposed project is to conduct an RCT designed to evaluate duration of ECALC effects over the course of 6 months, and to assess the impact of smart phone-delivered boosters on maintenance and enhancement of effects. Participants will be problematic drinking college students recruited from first time in college new students. Students will be randomly assigned to ECALC only, ECALC plus boosters, or assessment only control. Ecological momentary assessment (EMA) will be used to track alcohol use and expectancies for one week at baseline, three weeks post-intervention, and one-week intervals at 3 and 6 months. It is hypothesized that students who complete ECALC will demonstrate immediate changes in alcohol expectancies, and subsequently, this will drive lower alcohol use and lower rates of alcohol-related problems (relative to the assessment only control students). It is also hypothesized that changes in expectancies and reduction in alcohol use may decay over time among students who do not receive boosters, while biweekly boosters will promote maintenance or enhancement of effects. This study allows for the examination of (1) duration of ECALC effects up to 6 months, and (2) the impact of biweekly boosters delivered via smart phones. In addition, use of EMA to collect real time data on expectancies and alcohol use over the course of 6 months will allow us to (3) map potential changes in expectancies in relation to alcohol use during this critical period of transition. If successful, this project will validate the use of ECALC as an efficient and effective program for reducing alcohol use and drinking-related harms.

Eligibility criteria: Inclusion Criteria:

* Full-time Fist Year College Student
* AUDIT-C score = 5 or higher (women), 7 or higher (men).
* Fluent English speaker
* Able to consent to participate in research

Exclusion Criteria:

* Not a Student enrolled at University of Central Florida
* Pregnant
* AUDIT score =15 or higher

Primary outcomes:
measure: Change from Baseline in Alcohol Expectancies Measured Weekly with CEOA
timeFrame: Weeks 1, 2, 3, 4, 13, and 26
measure: Change from Baseline in Alcohol Use Measured Weekly with Retrospective Self-report Measure
timeFrame: Weeks 1, 2, 3, 4, 13, and 26
measure: Change from Baseline in Alcohol-related Harms Measured Weekly with Retrospective Self-report Survey
timeFrame: Weeks 1, 2, 3, 4, 13, and 26
measure: Change from Baseline in Sociocultural Attitudes Towards Appearance Measured Weekly with Self-report Survey
timeFrame: Weeks 1, 2, 3, 4, 13, and 26
measure: Change from Baseline in Alcohol Expectancies Measured Daily with Ecological Momentary Assessment (EMA)
timeFrame: Daily for Weeks 1, 2, 3, 4, 13, and 26
measure: Change from Baseline in Alcohol Use Measured Daily with Ecological Momentary Assessment (EMA)
timeFrame: Daily for Weeks 1, 2, 3, 4, 13, and 26
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Michael E Dunn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: