Alcohol Use, UnderageECALCNCT05616247
Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing College Student Alcohol Use and Harms
A study testing ECALC and ECALC Plus Weekly Boosters in people with Alcohol Use, Underage and Harmful; Use, Alcohol, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Underage, Harmful; Use, Alcohol
- What is being tested?
- ECALC and ECALC Plus Weekly Boosters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a Student enrolled at University of Central Florida
- Pregnant
- AUDIT score =15 or higher
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816-0001
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use, Underage, Harmful; Use, Alcohol
- Being tested
- ECALC, ECALC Plus Weekly Boosters
- Keywords
- College Alcohol Use, Expectancies, Expectancy Challenge, Expectancy Challenge Alcohol Literacy Curriculum, Alcohol-Related Harms, Underage Alcohol Use
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECALCBehavioural
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention
ECALC Plus Weekly BoostersBehavioural
Expectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention Plus Weekly Booster Content Delivered by Mobile Device
| Study group | Role | What they receive |
|---|---|---|
| ECALC | Experimental | Cognitive Behavioral Program to Change Expectancy Processes Receives: Behavioral: ECALC |
| ECALC Plus Weekly Boosters | Experimental | Cognitive Behavioral Program to Change Expectancy Processes with Weekly Booster Content Delivered by Mobile Device Receives: Behavioral: ECALC Plus Weekly Boosters |
| Control | No intervention | Control Group Presentation on Body Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Daily for Weeks 1, 2, 3, 4, 13, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start22 Sep 2022
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use, UnderageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E Dunn, Ph.D., Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616247
- Sponsor's protocol ID
- 1R15AA028909-01A1
- Acronym
- ECALC
- Status last verified
- May 2024
- First submitted
- 7 Nov 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Didentified data will be placed in NIH approved data repository (currently https://cos.io/our-products/osf/).
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Long-term Efficacy of the Expectancy Challenge Alcohol Literacy Curriculum on Reducing Adverse Alcohol Outcomes
- ClinicalTrials.gov ID
- NCT05616247
- Acronym / sponsor ID
- ECALC / 1R15AA028909-01A1
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECALC | Experimental | Behavioral: ECALCCognitive Behavioral Program to Change Expectancy Processes |
| ECALC Plus Weekly Boosters | Experimental | Behavioral: ECALC Plus Weekly BoostersCognitive Behavioral Program to Change Expectancy Processes with Weekly Booster Content Delivered by Mobile Device |
| Control | No intervention | –Control Group Presentation on Body Image |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not a Student enrolled at University of Central Florida
- Pregnant
- AUDIT score =15 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECALCExpectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention | Behavioural | ECALC |
| ECALC Plus Weekly BoostersExpectancy Challenge Alcohol Literacy Curriculum Cognitive Behavioral Intervention Plus Weekly Booster Content Delivered by Mobile Device | Behavioural | ECALC Plus Weekly Boosters |
Primary outcome
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.
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.
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.
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.
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes. Didentified data will be placed in NIH approved data repository (currently https://cos.io/our-products/osf/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Dunn, Ph.D. principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECALC and ECALC Plus Weekly Boosters in people with Alcohol Use, Underage and Harmful; Use, Alcohol, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Alcohol Expectancies Measured Weekly with CEOA (time frame: Weeks 1, 2, 3, 4, 13, and 26). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.