An interventional study of PNF+ PBI and SNMC+ PBI in Underage Drinking, sponsored by Loyola Marymount University. Enrolling by invitation at 1 site in United States. Open to participants aged 17 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Loyola Marymount University · Not applicable, Interventional, and Prevention
A randomized controlled trial (RCT) will be conducted to evaluate both the short-term and long-term efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Although the current NIAAA-recommended Parent Handbook has shown modest effects, our preliminary work suggests that combining personalized normative feedback (PNF) delivered through a social media-inspired app with psychoeducational content can effectively decrease alcohol-related risk. In this large, multi-site trial with 2,040 first-year students, we will examine the short- and long-term effects of the experimental app-based PNF program (PNF+ PBI) compared to an email-based social norms marketing campaign (SNMC+ PBI), the Parent Handbook (PH+ PBI), and an assessment-only control on alcohol use and consequences (primary outcomes). Parent alcohol approval and communication will also be assessed as potential mediators of intervention effects (secondary outcomes). The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related consequences compared to those whose parents receive PH+ PBI or no intervention. It is also expected that parental approval will be lower and alcohol-related communication will be higher in these two experimental conditions, relative to PH+ PBI and no intervention.
A randomized controlled trial (RCT) will be conducted to evaluate the feasibility and efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Incoming first-year students will be invited to complete an online baseline survey during the summer prior to matriculation to assess alcohol use and related behaviors. An automated randomizer embedded in the survey will assign students (and thus their parents) to one of four conditions: an experimental app-based personalized normative feedback program (PNF+ PBI), an email-based social norms marketing campaign (SNMC+ PBI), the NIAAA-recommended Parent Handbook (PH+ PBI), or an assessment-only control group. Parents in the PBI conditions will receive access to their assigned program in July or August (immediately following their students completion of the baseline survey). Students will complete a total of four surveys: the baseline assessment and three follow-up surveys at one month, six months, and twelve months post-matriculation. The researchers hypothesize that students whose parents are assigned to the experimental app-based PNF and email-based SNMC conditions will report lower alcohol use and fewer alcohol-related consequences compared to those whose parents receive the Parent Handbook or no intervention. In addition, it is expected that these experimental conditions will yield lower parental alcohol approval and higher levels of alcohol-related communication, which will serve as potential mediators of the intervention effects.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's planned enrollment of 2,040 is above the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Loyola Marymount University is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This intervention involves an interactive app that delivers six personalized normative feedback quizzes. Based on quiz responses, the app provides tailored videos and readings that address parents' misperceptions about student drinking and offer strategies to reduce alcohol-related risks. The app also includes a resource library and generates customized reading lists through the quizzes.
Behavioral: PNF+ PBI
This intervention consists of a series of six structured communications that present risk-reducing normative facts about alcohol use. Each communication includes a specific tip designed to guide parents in effectively discussing alcohol-related risks and establishing constructive conversations with their student.
Behavioral: SNMC+ PBI
This intervention provides a digital version of the Parent Handbook, which contains comprehensive psychoeducational content on alcohol-related risks, effective communication strategies, and practical guidelines for reducing underage drinking. The Handbook is designed to be reviewed at the parent's own pace, offering a thorough resource for managing alcohol-related issues.
Behavioral: PH+ PBI
In the control condition, no parent-based intervention content is provided.
Parents of participating students assigned to the PNF+ PBI condition will receive an email invitation to sign up for a Parent-Based Intervention app. This app features six personalized normative feedback (PNF) quizzes and provides tailored videos and readings based on responses to these quizzes. Parents will create an account and complete the first PNF quiz, after which they will immediately receive their initial set of tailored content. They can then explore additional app content at their convenience, including access to five more quizzes that will yield further customized reading lists and access to a general resource library. For approximately six weeks, parents will receive weekly app notifications and email reminders alerting them to additional unengaged content (e.g., PNF quizzes, readings). Parents in this condition will maintain access to the app throughout their student's first year of college.
Parents of participating students randomized to this condition will receive a series of 6 emails (delivered weekly) in August and September. Each email will include risk-reducing normative facts and a relevant tip for communicating with students about alcohol-related risks.
Parents of participating students randomized to this condition will receive an email introducing the PBI including a link to access the Handbook online. Parents can explore the Handbook at their own pace.
Also known as: Digitized Parent Handbook
Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention
Self-reported number of drinks consumed during an average week in the past 30 days.
Time frame: baseline, 3 months
Change in Baseline Daily Drinking from Baseline to 7 Months Post Intervention
Self-reported number of drinks consumed during an average week in the past 30 days.
Time frame: baseline, 7 months
Change in Baseline Daily Drinking from Baseline to 12 Months Post Intervention
Self-reported number of drinks consumed during an average week in the past 30 days.
Time frame: baseline, 12 months
Change in Peak Drinking from Baseline to 1 Month Post Intervention
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Time frame: baseline, 1 month
Change in Peak Drinking from Baseline to 7 Months Post Intervention
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Time frame: baseline, 7 months
Change in Peak Drinking from Baseline to 12 Months Post Intervention
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Time frame: baseline, 12 months
Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Time frame: baseline, 1 month
Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Time frame: baseline, 7 months
Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Time frame: baseline, 12 months
Change in High Intensity Drinking from Baseline to 1 Month Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Time frame: baseline, 1 month
Change in High Intensity Drinking from Baseline to 7 Months Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Time frame: baseline, 7 months
Change in High Intensity Drinking from Baseline to 12 Months Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Time frame: baseline, 12 months
Change in Alcohol-Related Consequences from Baseline to 1 Month Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Time frame: baseline, 1 month
Change in Alcohol-Related Consequences from Baseline to 7 Months Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Time frame: baseline, 7 months
Change in Alcohol-Related Consequences from Baseline to 12 Months Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Time frame: baseline, 12 months
Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention
Self-reported number of drinks parent would permit student to drink in the next year.
Time frame: baseline, 1 month
Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention
Self-reported number of drinks parent would permit student to drink in the next year.
Time frame: baseline, 7 months
Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention
Self-reported number of drinks parent would permit student to drink.
Time frame: baseline, 12 months
Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention
Self-reported frequency of parent communication in the past 3 months.
Time frame: baseline, 1 month
Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention
Self-reported frequency of parent communication in the past 3 months.
Time frame: baseline, 7 months
Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention
Self-reported frequency of parent communication in the past 3 months.
Time frame: baseline, 12 months
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Loyola Marymount University