Alcohol Use Disorder Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04788004 -
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
|
||
Recruiting |
NCT05684094 -
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
|
N/A | |
Completed |
NCT03406039 -
Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems
|
N/A | |
Completed |
NCT03573167 -
Mobile Phone-Based Motivational Interviewing in Kenya
|
N/A | |
Completed |
NCT04817410 -
ED Initiated Oral Naltrexone for AUD
|
Phase 1 | |
Active, not recruiting |
NCT04267692 -
Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
|
N/A | |
Completed |
NCT03872128 -
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
|
Phase 1 | |
Completed |
NCT02989662 -
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
|
Phase 1/Phase 2 | |
Recruiting |
NCT06030154 -
Amplification of Positivity for Alcohol Use
|
N/A | |
Active, not recruiting |
NCT05419128 -
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04203966 -
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
|
||
Recruiting |
NCT05861843 -
Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
|
||
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Enrolling by invitation |
NCT04128761 -
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
|
N/A | |
Not yet recruiting |
NCT06444243 -
Psilocybin-assisted Therapy for Alcohol Use Disorder
|
Phase 2 | |
Not yet recruiting |
NCT06337721 -
Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
|
N/A | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Enrolling by invitation |
NCT02544581 -
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
|
N/A |