Norms Re-education to Promote Engagement in Parent-based Interventions

Norms Re-education to Promote Engagement in Parent-based Interventions: a Type 1 Implementation-effectiveness Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Underage Drinking
• Intervention / Treatment: Behavioral: PNF+ PBI; Behavioral: SNMC+ PBI; Behavioral: PH+ PBI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 2040
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph LaBrie, Ph.D.; Phone Number: 3103385238; Email: jlabrie@lmu.edu
• Study Contact Backup: Name: Bradley Trager, Ph.D.; Phone Number: 310-338-3701; Email: bradley.trager@lmu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Loyola Marymount

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• LMU/Lehigh incoming first-year college student who is17-20 years of age
• Parent/legal guardian with an email address on file with the university
• A United States resident
• Provide informed consent/assent

Exclusion Criteria:

• Younger than 17 or older than 20 years of age
• Not an incoming first-year college students at LMU/Lehigh
• Parent or legal guardian does not have an email address on file with the university
• Not residents of the United States
• Did not provide informed consent/assent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNF+ PBI; 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; 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.
Experimental: SNMC+ 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; 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.
Active Comparator: PH+ 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; 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.; Other Names: Digitized Parent Handbook
No Intervention: No Intervention; In the control condition, no parent-based intervention content is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	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.	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.	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.	baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	baseline, 12 months

Collaborators and Investigators

• Sponsor: Loyola Marymount University
• Collaborators: Lehigh University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Underage Drinking
• Other Study ID Numbers: 1R01AA030904-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No