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

February 25, 2025 updated by: University of Central Florida

Immediate and Long-term Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing Adverse Alcohol Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32816-0001
        • University of Central Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ECALC
Cognitive Behavioral Program to Change Expectancy Processes
Behavioral: ECALC
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention
Experimental: ECALC Plus Weekly Boosters
Cognitive Behavioral Program to Change Expectancy Processes with Weekly Booster Content Delivered by Mobile Device
Behavioral: ECALC Plus Weekly Boosters
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention Plus Weekly Booster Content Delivered by Mobile Device
No Intervention: Control
Control Group Presentation on Body Image

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Alcohol Expectancies Measured Weekly with CEOA
Time Frame: Weeks 1, 2, 3, 4, 13, and 26
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.
Weeks 1, 2, 3, 4, 13, and 26
Change from Baseline in Alcohol Use Measured Weekly with Retrospective Self-report Measure
Time Frame: Weeks 1, 2, 3, 4, 13, and 26
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.
Weeks 1, 2, 3, 4, 13, and 26
Change from Baseline in Alcohol-related Harms Measured Weekly with Retrospective Self-report Survey
Time Frame: Weeks 1, 2, 3, 4, 13, and 26
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.
Weeks 1, 2, 3, 4, 13, and 26
Change from Baseline in Sociocultural Attitudes Towards Appearance Measured Weekly with Self-report Survey
Time Frame: Weeks 1, 2, 3, 4, 13, and 26
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.
Weeks 1, 2, 3, 4, 13, and 26
Change from Baseline in Alcohol Expectancies Measured Daily with Ecological Momentary Assessment (EMA)
Time Frame: Daily for Weeks 1, 2, 3, 4, 13, and 26
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).
Daily for Weeks 1, 2, 3, 4, 13, and 26
Change from Baseline in Alcohol Use Measured Daily with Ecological Momentary Assessment (EMA)
Time Frame: Daily for Weeks 1, 2, 3, 4, 13, and 26
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.
Daily for Weeks 1, 2, 3, 4, 13, and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael E Dunn, Ph.D., University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R15AA028909-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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