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College DrinkingGANDRNCT04356261

Revolutionizing Normative Re-education

A study testing Gamified Personalized Normative Feedback in people with College Drinking and Underage Drinking, run by Loyola Marymount University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around… Read more about this study

Who is it for?
Ages 18 to 20 yearsHealthy volunteers can take part
What is being tested?
Gamified Personalized Normative Feedback
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,143 participants
Where
1 siteUnited States
Study dates
15 Aug 2021to 25 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • Not meeting inclusion criteria
  • Unwillingness to participate (indicated by failure to accept Terms of Service \& Privacy Policy, or provide informed consent)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Loyola Marymount University

    Los Angeles, California, 90045

Other trials in United States

About this study

Official title: Revolutionizing Normative Re-education: Delivering Enhanced PNF Within a Social Media Inspired Game About College Life

Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around testing first-year students' perceptions about the attitudes and behaviors of their peers in a variety of campus-relevant domains. Five pilot studies suggest that CampusGANDR will be significantly more effective at correcting students' normative misperceptions and reducing their alcohol use than standard PNF, especially among heavier-drinking students and those with greater exposure to alcohol on social media, and that these larger effects are driven by the significantly decreased psychological reactance experienced by students when viewing feedback as part of a game about college life rather than as part of an alcohol-focused program. The current project seeks to 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site trial, 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use across 12 weeks of gameplay among non-drinking, moderate-drinking, and heavy-drinking students, 3) examine person-level moderators of these effects, and 4) evaluate CampusGANDR engagement and sustainability among students who play voluntarily but are not involved in the randomized controlled trial.

Read the detailed description

Despite concerted efforts, high risk drinking remains a significant problem on college campuses. Further, the transition into college is an identified critical period in which risky drinking patterns are often established and serious negative consequences occur. Colleges commonly employ Normative Re-Education (NR), a promising intervention approach focused on correcting over-estimated peer drinking norms, to reduce alcohol risk in first-year students. However, the most cost-effective and scalable NR intervention strategy, web-based personalized normative feedback (PNF), has yielded only modest reductions in drinking. Several issues have been identified that may explain these relatively small effects. For example, students often question the credibility of the normative data, the content fails to capture students' attention, and heavy drinkers often react to feedback defensively. These issues are not surprising as, unlike social media and digital gaming applications that capture and sustain young adults' attention, web-based PNF formats lack the sophisticated digital graphics, social interactivity, and other dynamic features to which students have become accustomed. Further, colleges often make participation mandatory or offer incentives to enroll students in current interventions, likely a detriment to student motivation and thus intervention effectiveness. CampusGANDR (Gamified Alcohol Norm Discovery and Re-education) addresses these issues by delivering alcohol PNF within a fun, gamified smartphone app that tests first-year students' perceptions of college life and classmates' attitudes and behaviors on a weekly basis across the first semester of college. Integrating features from popular social media platforms and evidence-based digital game mechanics (e.g., co-presence, a wager-based system of points, and chance-based uncertainty), CampusGANDR also features enhanced PNF and includes several novel features informed by longstanding cognitive and social psychological theories.

Based on extensive pilot work, the current proposal seeks to: 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site randomized controlled trial (RCT); 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use among students who differ in alcohol use (non-drinkers, light to moderate drinkers, and heavy drinkers); 3) examine person-level moderators of intervention efficacy; and 4) evaluate CampusGANDR engagement and the sustainability of play among students who use the app but aren't recruited into the evaluation study (RCT).

Incoming first-year students at colleges and universities in California (Loyola Marymount University site) and Texas (University of Houston site) consecutive cohorts of first-year students will be invited to download the CampusGANDR app to test their perceptions of campus life compete against their classmates. Then, among students already playing CampusGANDR, a balanced sub-sample of 1,800 non-drinking, light/moderate drinking, and heavy drinking students will be invited to take part in an evaluation study (RCT). Study participants will play CampusGANDR over the initial 12 weeks of the fall semester and complete 4 surveys assessing their alcohol use, social media use, health behaviors, mental health, and adjustment to college. Study participants will be discretely randomized to receive alcohol feedback 0%, 33%, or 67% of weekly CampusGANDR rounds through a backend manipulation of chance elements. Students not meeting study eligibility criteria and those not electing to take part in the evaluation study will still take part in CampusGANDR. The dosage of alcohol feedback among these non-RCT players receive will be determined at random and their app usage data will be employed to assess app engagement and sustainability of play in the absence of study incentives. This project aims to culminate in a highly engaging, scalable, cutting-edge native smartphone app (IOS, Android) able to dynamically tailor the dosage of alcohol feedback delivered based on students' alcohol experience at the point of matriculation.

Being tested
Gamified Personalized Normative Feedback
Keywords
Prevention, Social norms
Medical subject headings
Alcohol Drinking in College, Underage Drinking, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamified Personalized Normative FeedbackBehavioural

    Also called GANDR

    Each week, all players will answer 3 questions of interest about first-year students' attitudes and behaviors (e.g., drinking, partying, exercising, studying, dorm life, etc.) generated by the student players. They will also guess how the typical same-sex student at their University answered the same questions and wager points on how close to the correct answer (group norm) each of their guesses is. Further, they will rate (e.g., thumbs up/thumbs down) the reported behaviors of other players and, then, submit and vote on questions for subsequent rounds. At the end of each week, players will receive enhanced personalized normative feedback feedback on two of the three questions, and receive feedback on how other students rated the answer they reported (preferred-sex injunctive norms).

Study groups in NCT04356261
Study groupRoleWhat they receive
Control PNFPlacebo comparatorPersonalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
Receives: Behavioral: Gamified Personalized Normative Feedback
Light Dose of Alcohol PNFActive comparatorPersonalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
Receives: Behavioral: Gamified Personalized Normative Feedback
Heavy Dose of Alcohol PNFActive comparatorPersonalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
Receives: Behavioral: Gamified Personalized Normative Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline Daily Drinking at 4 Months

    The Daily Drinking Questionnaire assessess the number of drinks consumed per week in a typical week over the past three months.

    Measured: baseline, 4 months

  2. Change From Baseline Daily Drinking at 9 Months

    The Daily Drinking Questionnaire assesses the number of drinks consumed per week in a typical week over the past three months.

    Measured: baseline, 9 months

  3. Change From Baseline Daily Drinking at 12 Months

    Assesses number of drinks consumed during an average week over the past month

    Measured: baseline, 12 months

  4. Change From Baseline Alcohol Consequences at 4 Months

    Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).

    Measured: baseline, 4 months

  5. Change From Baseline Alcohol Consequences at 9 Months

    Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).

    Measured: baseline, 9 months

  6. Change From Baseline Alcohol Consequences at 12 Months

    Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).

    Measured: baseline, 12 months

  7. Change From Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months

    We used the Quantity/Frequency/Peak Alcohol measure to assess peak drinks. Participants reported the largest number of drinks they consumed on one occasion in the past 30 days.

    Measured: baseline, 4 months

  8. Change From Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months

    Assesses frequency and quantity of alcohol consumption over the past month

    Measured: baseline, 9 months

  9. Change From Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months

    Assesses frequency and quantity of alcohol consumption over the past month

    Measured: baseline, 12 months

Secondary outcomes (9)
  1. Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months

    Assesses perceptions of weekly alcohol consumption among peers over the past month

    Measured: baseline, 4 months

  2. Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months

    Assesses perceptions of weekly alcohol consumption among peers over the past month

    Measured: baseline, 9 months

  3. Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months

    Assesses perceptions of weekly alcohol consumption among peers over the past month

    Measured: baseline, 12 months

  4. Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months

    Assesses perceptions of peers' frequency and quantity of drinking over the past month

    Measured: baseline, 4 months

  5. Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months

    Assesses perceptions of peers' frequency and quantity of drinking over the past month

    Measured: baseline, 9 months

  6. Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months

    Assesses perceptions of peers' frequency and quantity of drinking over the past month

    Measured: baseline, 12 months

  7. Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 4 Months

    Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.

    Measured: baseline, 4 months

  8. Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 9 Months

    Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.

    Measured: baseline, 9 months

  9. Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 12 Months

    Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors; group-level data are summarized using the Mean (Measure Type) and SD (Dispersion Type).

    Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start15 Aug 2021
  3. Primary completion25 Oct 2024
  4. Study completion25 Oct 2024

Resources

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
Model description
Based on condition assignment, participants could see up to 6 alcohol feedbacks (More Alcohol Feedback; MAF), up to 3 alcohol feedbacks (Less Alcohol Feedbacks; LAF) or 0 alcohol feedbacks (No Alcohol Feedback; NAF).
Masking
Single blind
Who is masked
Participant
Enrolment
1,143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356261
Sponsor's protocol ID
LMU IRB 2019 SP 49-R
Acronym
GANDR
Status last verified
Mar 2026
First submitted
9 Apr 2020
Last updated
1 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study results will be reported in aggregate, so that individual participants will not be identifiable in any research reports or presentations of the proposed study. A de-identified dataset will be made available to researchers 1 year after the initial publication of results. This dataset will include participant demographics and outcome measures assessed at baseline and the follow-up surveys. A data dictionary will be provided.

Questions about this trial

What is this clinical trial studying?

A study testing Gamified Personalized Normative Feedback in people with College Drinking and Underage Drinking, run by Loyola Marymount University 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 0 inclusion and 2 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: finished, as of the sponsor's last update on 1 May 2026. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Daily Drinking at 4 Months (time frame: baseline, 4 months). The study lists 9 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 1 May 2026.

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