Revolutionizing Normative Re-education (GANDR)
Primary Purpose
College Drinking, Underage Drinking, Alcohol Use Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gamified Personalized Normative Feedback
Sponsored by
About this trial
This is an interventional prevention trial for College Drinking focused on measuring Prevention, Social norms
Eligibility Criteria
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)
Sites / Locations
- Loyola Marymount UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control PNF
Light Dose of Alcohol PNF
Heavy Dose of Alcohol PNF
Arm Description
Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
Outcomes
Primary Outcome Measures
Change from Baseline Daily Drinking at 4 Months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Daily Drinking at 9 Months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Daily Drinking at 12 Months
Assesses number of drinks consumed during an average week over the past month
Change from Baseline Alcohol Consequences at 4 Months
Assesses experience of negative alcohol outcomes
Change from Baseline Alcohol Consequences at 9 Months
Assesses experience of negative alcohol outcomes
Change from Baseline Alcohol Consequences at 12 Months
Assesses experience of negative alcohol outcomes
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
Assesses frequency and quantity of alcohol consumption over the past month
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
Assesses frequency and quantity of alcohol consumption over the past month
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
Assesses frequency and quantity of alcohol consumption over the past month
Secondary Outcome Measures
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
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
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
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
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
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
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 4 Months
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 9 Months
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 12 Months
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Full Information
NCT ID
NCT04356261
First Posted
April 9, 2020
Last Updated
April 11, 2023
Sponsor
Loyola Marymount University
Collaborators
University of Houston
1. Study Identification
Unique Protocol Identification Number
NCT04356261
Brief Title
Revolutionizing Normative Re-education
Acronym
GANDR
Official Title
Revolutionizing Normative Re-education: Delivering Enhanced PNF Within a Social Media Inspired Game About College Life
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola Marymount University
Collaborators
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
College Drinking, Underage Drinking, Alcohol Use Disorder
Keywords
Prevention, Social norms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Intervention condition is randomly assigned and the intervention delivery is digital, through a smartphone app. Senior members of the research team will have a record of the participants randomized to each condition but the delivery of all intervention content is automated within the mobile app. Junior members of the research team responsible for tracking participants and sending follow-up survey reminders will not be aware of participant condition assignment.
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control PNF
Arm Type
Placebo Comparator
Arm Description
Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
Arm Title
Light Dose of Alcohol PNF
Arm Type
Active Comparator
Arm Description
Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
Arm Title
Heavy Dose of Alcohol PNF
Arm Type
Active Comparator
Arm Description
Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
Intervention Type
Behavioral
Intervention Name(s)
Gamified Personalized Normative Feedback
Other Intervention Name(s)
GANDR
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline Daily Drinking at 4 Months
Description
Assesses number of drinks consumed during an average week over the past month
Time Frame
baseline, 4 months
Title
Change from Baseline Daily Drinking at 9 Months
Description
Assesses number of drinks consumed during an average week over the past month
Time Frame
baseline, 9 months
Title
Change from Baseline Daily Drinking at 12 Months
Description
Assesses number of drinks consumed during an average week over the past month
Time Frame
baseline, 12 months
Title
Change from Baseline Alcohol Consequences at 4 Months
Description
Assesses experience of negative alcohol outcomes
Time Frame
baseline, 4 months
Title
Change from Baseline Alcohol Consequences at 9 Months
Description
Assesses experience of negative alcohol outcomes
Time Frame
baseline, 9 months
Title
Change from Baseline Alcohol Consequences at 12 Months
Description
Assesses experience of negative alcohol outcomes
Time Frame
baseline, 12 months
Title
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
Description
Assesses frequency and quantity of alcohol consumption over the past month
Time Frame
baseline, 4 months
Title
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
Description
Assesses frequency and quantity of alcohol consumption over the past month
Time Frame
baseline, 9 months
Title
Change from Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
Description
Assesses frequency and quantity of alcohol consumption over the past month
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months
Description
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time Frame
baseline, 4 months
Title
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months
Description
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time Frame
baseline, 9 months
Title
Change from Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months
Description
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time Frame
baseline, 12 months
Title
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months
Description
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time Frame
baseline, 4 months
Title
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months
Description
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time Frame
baseline, 9 months
Title
Change from Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months
Description
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time Frame
baseline, 12 months
Title
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 4 Months
Description
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Time Frame
baseline, 4 months
Title
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 9 Months
Description
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Time Frame
baseline, 9 months
Title
Change from Baseline Injunctive Peer Drinking Norms (adapted from Baer, 1994) at 12 Months
Description
Assesses perceptions of peer approval for underage drinking behaviors and experiences
Time Frame
baseline, 12 months
Other Pre-specified Outcome Measures:
Title
CampusGANDR number of student sign-ups per cohort per site
Description
percentage of each class at each University who downloaded the app and created an account
Time Frame
following the cohort's 17 week long CampusGANDR competition
Title
average number of CampusGANDR rounds played per non-RCT user
Description
the average number of rounds played by each app user not taking part in the evaluation study
Time Frame
following the cohort's 17 week long CampusGANDR competition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Loyola Marymount University
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah C Boyle, PhD
Phone
310-568-6681
Email
sarah.boyle@lmu.edu
First Name & Middle Initial & Last Name & Degree
Joseph W LaBrie, PhD
Phone
3103385238
Email
jlabrie@lmu.edu
First Name & Middle Initial & Last Name & Degree
Joseph W LaBrie, PhD
First Name & Middle Initial & Last Name & Degree
Sarah C Boyle, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
1 year following the publication of results.
IPD Sharing Access Criteria
Study materials and data will be made available to the public on a secure web portal.
Learn more about this trial
Revolutionizing Normative Re-education
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