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Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing College Student Alcohol Use and Harms (ECALC)

Primary Purpose

Alcohol Use, Underage, Harmful; Use, Alcohol

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECALC
ECALC Plus Weekly Boosters
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use, Underage focused on measuring College Alcohol Use, Expectancies, Expectancy Challenge, Expectancy Challenge Alcohol Literacy Curriculum, Alcohol-Related Harms, Underage Alcohol Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Central Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

ECALC

ECALC Plus Weekly Boosters

Control

Arm Description

Cognitive Behavioral Program to Change Expectancy Processes

Cognitive Behavioral Program to Change Expectancy Processes with Weekly Booster Content Delivered by Mobile Device

Control Group Presentation on Body Image

Outcomes

Primary Outcome Measures

Change from Baseline in Alcohol Expectancies Measured Weekly with CEOA
Expected effects of alcohol use measured with self-report survey. The survey is the 38 item Comprehensive Effects of Alcohol Scale (CEOA), a validated measure of alcohol expectancies. Participants complete the CEOA online on their mobile device and enter responses to each item. Scores range from 0 to 114 with higher scores indicating greater expectation of effects of consuming alcohol.
Change from Baseline in Alcohol Use Measured Weekly with Retrospective Self-report Measure
Self-reported alcohol use, quantity and frequency of consumption in standard drink format. Participants complete an online survey on their mobile device and enter the number of standard drinks consumed each day and number of hours spent drinking each day over the previous week.
Change from Baseline in Alcohol-related Harms Measured Weekly with Retrospective Self-report Survey
Self-reported Negative consequences associated with alcohol use measured with self-report survey. Participants complete an online survey on their mobile device. The survey is the Young Adult Alcohol Consequences Questionnaire. A 48-item validated measure with scores ranging from 0 to 67, higher scores indicate more harms.
Change from Baseline in Sociocultural Attitudes Towards Appearance Measured Weekly with Self-report Survey
Attitudes toward personal appearance measured with self-report survey. Participants complete an online survey on their mobile device. The survey is the Sociocultural Attitudes Towards Appearance Questionnaire-4. A 22-item validated measure with scores ranging from 0 to 110, higher scores indicate more sociocultural emphasis on personal appearance and body image.
Change from Baseline in Alcohol Expectancies Measured Daily with Ecological Momentary Assessment (EMA)
Expected effects of alcohol use measured with 8 item self-report survey. Participants complete an online survey on their mobile device and enter responses to items each day. Scores range from 0 to 24 with higher scores indicating greater expectation of effects of consuming alcohol. Items were selected from the Comprehensive Expected Effects of Alcohol Scale (CEOA).
Change from Baseline in Alcohol Use Measured Daily with Ecological Momentary Assessment (EMA)
Self-reported alcohol use, quantity and frequency of consumption in standard drink format. Participants complete an online survey on their mobile device and enter the number of standard drinks consumed each day.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
September 20, 2023
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05616247
Brief Title
Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing College Student Alcohol Use and Harms
Acronym
ECALC
Official Title
Immediate and Long-term Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing Adverse Alcohol Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Underage, Harmful; Use, Alcohol
Keywords
College Alcohol Use, Expectancies, Expectancy Challenge, Expectancy Challenge Alcohol Literacy Curriculum, Alcohol-Related Harms, Underage Alcohol Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECALC
Arm Type
Experimental
Arm Description
Cognitive Behavioral Program to Change Expectancy Processes
Arm Title
ECALC Plus Weekly Boosters
Arm Type
Experimental
Arm Description
Cognitive Behavioral Program to Change Expectancy Processes with Weekly Booster Content Delivered by Mobile Device
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group Presentation on Body Image
Intervention Type
Behavioral
Intervention Name(s)
ECALC
Intervention Description
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention
Intervention Type
Behavioral
Intervention Name(s)
ECALC Plus Weekly Boosters
Intervention Description
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention Plus Weekly Booster Content Delivered by Mobile Device
Primary Outcome Measure Information:
Title
Change from Baseline in Alcohol Expectancies Measured Weekly with CEOA
Description
Expected effects of alcohol use measured with self-report survey. The survey is the 38 item Comprehensive Effects of Alcohol Scale (CEOA), a validated measure of alcohol expectancies. Participants complete the CEOA online on their mobile device and enter responses to each item. Scores range from 0 to 114 with higher scores indicating greater expectation of effects of consuming alcohol.
Time Frame
Weeks 1, 2, 3, 4, 13, and 26
Title
Change from Baseline in Alcohol Use Measured Weekly with Retrospective Self-report Measure
Description
Self-reported alcohol use, quantity and frequency of consumption in standard drink format. Participants complete an online survey on their mobile device and enter the number of standard drinks consumed each day and number of hours spent drinking each day over the previous week.
Time Frame
Weeks 1, 2, 3, 4, 13, and 26
Title
Change from Baseline in Alcohol-related Harms Measured Weekly with Retrospective Self-report Survey
Description
Self-reported Negative consequences associated with alcohol use measured with self-report survey. Participants complete an online survey on their mobile device. The survey is the Young Adult Alcohol Consequences Questionnaire. A 48-item validated measure with scores ranging from 0 to 67, higher scores indicate more harms.
Time Frame
Weeks 1, 2, 3, 4, 13, and 26
Title
Change from Baseline in Sociocultural Attitudes Towards Appearance Measured Weekly with Self-report Survey
Description
Attitudes toward personal appearance measured with self-report survey. Participants complete an online survey on their mobile device. The survey is the Sociocultural Attitudes Towards Appearance Questionnaire-4. A 22-item validated measure with scores ranging from 0 to 110, higher scores indicate more sociocultural emphasis on personal appearance and body image.
Time Frame
Weeks 1, 2, 3, 4, 13, and 26
Title
Change from Baseline in Alcohol Expectancies Measured Daily with Ecological Momentary Assessment (EMA)
Description
Expected effects of alcohol use measured with 8 item self-report survey. Participants complete an online survey on their mobile device and enter responses to items each day. Scores range from 0 to 24 with higher scores indicating greater expectation of effects of consuming alcohol. Items were selected from the Comprehensive Expected Effects of Alcohol Scale (CEOA).
Time Frame
Daily for Weeks 1, 2, 3, 4, 13, and 26
Title
Change from Baseline in Alcohol Use Measured Daily with Ecological Momentary Assessment (EMA)
Description
Self-reported alcohol use, quantity and frequency of consumption in standard drink format. Participants complete an online survey on their mobile device and enter the number of standard drinks consumed each day.
Time Frame
Daily for Weeks 1, 2, 3, 4, 13, and 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Dunn, Ph.D.
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816-0001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Didentified data will be placed in NIH approved data repository (currently https://cos.io/our-products/osf/).
IPD Sharing Time Frame
Data available May 01, 2026 Availability indefinite
IPD Sharing Access Criteria
Access will be open.

Learn more about this trial

Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing College Student Alcohol Use and Harms

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