- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356261
Revolutionizing Normative Re-education (GANDR)
Revolutionizing Normative Re-education: Delivering Enhanced PNF Within a Social Media Inspired Game About College Life
Study Overview
Status
Intervention / Treatment
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).
At two distinctly different campuses (Loyola Marymount University and the University of Houston) 3 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 (300 students per site per year) 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90045
- Recruiting
- Loyola Marymount University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
To play CampusGANDR individuals must:
- Have access to either a smartphone or a computer with internet capabilities on which the app can be accessed
- Be at least 18 years of age and currently enrolled as an incoming first-year student at one of the two study sites.
- Accept CampusGANDR Terms of Service & Privacy Policy. Additional RCT Inclusion Criteria
To take part in the evaluation study participants must:
- Be a CampusGANDR user between 18 and 20 years old
- Answer screening questions and screen into an open stratum
- Review and accept the evaluation study Informed Consent form
Exclusion criteria for both:
- Not meeting inclusion criteria
- Unwillingness to participate (indicated by failure to accept Terms of Service & Privacy Policy, or provide informed consent)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control PNF
Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
|
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).
Other Names:
|
Active Comparator: Light Dose of Alcohol PNF
Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
|
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).
Other Names:
|
Active Comparator: Heavy Dose of Alcohol PNF
Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Daily Drinking at 4 Months
Time Frame: baseline, 4 months
|
Assesses number of drinks consumed during an average week over the past month
|
baseline, 4 months
|
Change from Baseline Daily Drinking at 9 Months
Time Frame: baseline, 9 months
|
Assesses number of drinks consumed during an average week over the past month
|
baseline, 9 months
|
Change from Baseline Daily Drinking at 12 Months
Time Frame: baseline, 12 months
|
Assesses number of drinks consumed during an average week over the past month
|
baseline, 12 months
|
Change from Baseline Alcohol Consequences at 4 Months
Time Frame: baseline, 4 months
|
Assesses experience of negative alcohol outcomes
|
baseline, 4 months
|
Change from Baseline Alcohol Consequences at 9 Months
Time Frame: baseline, 9 months
|
Assesses experience of negative alcohol outcomes
|
baseline, 9 months
|
Change from Baseline Alcohol Consequences at 12 Months
Time Frame: baseline, 12 months
|
Assesses experience of negative alcohol outcomes
|
baseline, 12 months
|
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
Time Frame: baseline, 4 months
|
Assesses frequency and quantity of alcohol consumption over the past month
|
baseline, 4 months
|
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
Time Frame: baseline, 9 months
|
Assesses frequency and quantity of alcohol consumption over the past month
|
baseline, 9 months
|
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
Time Frame: baseline, 12 months
|
Assesses frequency and quantity of alcohol consumption over the past month
|
baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months
Time Frame: baseline, 4 months
|
Assesses perceptions of weekly alcohol consumption among peers over the past month
|
baseline, 4 months
|
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months
Time Frame: baseline, 9 months
|
Assesses perceptions of weekly alcohol consumption among peers over the past month
|
baseline, 9 months
|
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months
Time Frame: baseline, 12 months
|
Assesses perceptions of weekly alcohol consumption among peers over the past month
|
baseline, 12 months
|
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months
Time Frame: baseline, 4 months
|
Assesses perceptions of peers' frequency and quantity of drinking over the past month
|
baseline, 4 months
|
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months
Time Frame: baseline, 9 months
|
Assesses perceptions of peers' frequency and quantity of drinking over the past month
|
baseline, 9 months
|
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months
Time Frame: baseline, 12 months
|
Assesses perceptions of peers' frequency and quantity of drinking over the past month
|
baseline, 12 months
|
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 4 Months
Time Frame: baseline, 4 months
|
Assesses perceptions of peer approval for underage drinking behaviors and experiences
|
baseline, 4 months
|
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 9 Months
Time Frame: baseline, 9 months
|
Assesses perceptions of peer approval for underage drinking behaviors and experiences
|
baseline, 9 months
|
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 12 Months
Time Frame: baseline, 12 months
|
Assesses perceptions of peer approval for underage drinking behaviors and experiences
|
baseline, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CampusGANDR number of student sign-ups per cohort per site
Time Frame: following the cohort's 17 week long CampusGANDR competition
|
percentage of each class at each University who downloaded the app and created an account
|
following the cohort's 17 week long CampusGANDR competition
|
average number of CampusGANDR rounds played per non-RCT user
Time Frame: following the cohort's 17 week long CampusGANDR competition
|
the average number of rounds played by each app user not taking part in the evaluation study
|
following the cohort's 17 week long CampusGANDR competition
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMU IRB 2019 SP 49-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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