NCT05616247

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 28, 2025

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

November 7, 2022

Last Update Submit

February 25, 2025

Conditions

Keywords

College Alcohol UseExpectanciesExpectancy ChallengeExpectancy Challenge Alcohol Literacy CurriculumAlcohol-Related HarmsUnderage Alcohol Use

Outcome Measures

Primary Outcomes (6)

  • 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.

    Weeks 1, 2, 3, 4, 13, and 26

  • 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.

    Weeks 1, 2, 3, 4, 13, and 26

  • 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.

    Weeks 1, 2, 3, 4, 13, and 26

  • 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.

    Weeks 1, 2, 3, 4, 13, and 26

  • 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).

    Daily for Weeks 1, 2, 3, 4, 13, and 26

  • 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.

    Daily for Weeks 1, 2, 3, 4, 13, and 26

Study Arms (3)

ECALC

EXPERIMENTAL

Cognitive Behavioral Program to Change Expectancy Processes

Behavioral: ECALC

ECALC Plus Weekly Boosters

EXPERIMENTAL

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

Behavioral: ECALC Plus Weekly Boosters

Control

NO INTERVENTION

Control Group Presentation on Body Image

Interventions

ECALCBEHAVIORAL

Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention

ECALC

Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention Plus Weekly Booster Content Delivered by Mobile Device

ECALC Plus Weekly Boosters

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816-0001, United States

Location

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Officials

  • Michael E Dunn, Ph.D.

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

September 22, 2022

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

February 28, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Didentified data will be placed in NIH approved data repository (currently https://cos.io/our-products/osf/).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data available May 01, 2026 Availability indefinite
Access Criteria
Access will be open.

Locations