Revolutionizing Normative Re-education

NCT04356261 | Completed Results DMC

• 1 other identifier: LMU IRB 2019 SP 49-R
• Study Type: interventional
• Target: 1,143
• Locations: 1 country
• Sites: 1

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.

Conditions

College Drinking; Alcohol Use Disorder; Underage Drinking

Keywords

Prevention; Social norms

Outcome Measures

Primary Outcomes (9)

• 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.

  baseline, 4 months

• 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.

  baseline, 9 months

• Change From Baseline Daily Drinking at 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

  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).

  baseline, 4 months

• 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).

  baseline, 9 months

• 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).

  baseline, 12 months

• 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.

  baseline, 4 months

• Change From Baseline Quantity/Frequency/Peak Alcohol Use at 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

  Assesses frequency and quantity of alcohol consumption over the past month

  baseline, 12 months

Secondary Outcomes (9)

• Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months

  baseline, 4 months

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

  baseline, 9 months

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

  baseline, 12 months

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

  baseline, 4 months

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

  baseline, 9 months

Study Arms (3)

Control PNF

PLACEBO COMPARATOR

Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)

Behavioral: Gamified Personalized Normative Feedback

Light Dose of Alcohol PNF

ACTIVE COMPARATOR

Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds

Behavioral: Gamified Personalized Normative Feedback

Heavy Dose of Alcohol PNF

ACTIVE COMPARATOR

Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds

Behavioral: Gamified Personalized Normative Feedback

Interventions

Gamified Personalized Normative Feedback BEHAVIORAL

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).

Also known as: GANDR

Control PNF; Heavy Dose of Alcohol PNF; Light Dose of Alcohol PNF

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unwillingness to participate (indicated by failure to accept Terms of Service \& Privacy Policy, or provide informed consent)

Sponsors & Collaborators

• Loyola Marymount University: lead
• University of Houston: collaborator

Study Sites (1)

Loyola Marymount University

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Alcohol Drinking in College; Underage Drinking; Alcoholism

Condition Hierarchy (Ancestors)

Alcohol Drinking; Drinking Behavior; Behavior; Adolescent Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Clayton Neighbors
• Organization: University of Houston

cneighbors@central.uh.edu

7137432616

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 22, 2020
• Study Start: August 15, 2021
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year following the publication of results.
• Access Criteria: Study materials and data will be made available to the public on a secure web portal.

Locations

US (1)