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

NCT06871982 | Not Yet Recruiting DMC

• 1 other identifier: 1R01AA030904-01
• Study Type: interventional
• Target: 2,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Underage Drinking

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (6)

• Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention

  baseline, 1 month

• Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention

  baseline, 7 months

• Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention

  baseline, 12 months

• Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention

  baseline, 1 month

• Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention

  baseline, 7 months

Study Arms (4)

PNF+ PBI

EXPERIMENTAL

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

SNMC+ PBI

EXPERIMENTAL

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

PH+ PBI

ACTIVE COMPARATOR

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

No Intervention

NO INTERVENTION

In the control condition, no parent-based intervention content is provided.

Interventions

PNF+ PBI BEHAVIORAL

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.

PNF+ PBI

SNMC+ PBI BEHAVIORAL

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.

SNMC+ PBI

PH+ PBI BEHAVIORAL

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

PH+ PBI

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola Marymount University: lead
• Lehigh University: collaborator

Study Sites (1)

Loyola Marymount

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Underage Drinking

Interventions

5-brom-3-(ortho-chlorphenyl)-1-(4-(4-phenyl-1-piperazinyl)butyl)indazole

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior

Central Study Contacts

Joseph LaBrie, Ph.D.

CONTACT

3103385238; jlabrie@lmu.edu

Bradley Trager, Ph.D.

CONTACT

310-338-3701; bradley.trager@lmu.edu

Study Design

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

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

US (1)