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NCT Number: NCT06871982

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

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.

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Key information

Conditions

Underage Drinking Adolescent Behavior Alcohol Drinking Behavior Drinking Behavior

Age range

17 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola Marymount

Los Angeles, California, 90045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Other names: Digitized Parent Handbook

Primary outcomes

  1. Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention

    Time frame: baseline, 3 months

    Self-reported number of drinks consumed during an average week in the past 30 days.

  2. Change in Baseline Daily Drinking from Baseline to 7 Months Post Intervention

    Time frame: baseline, 7 months

    Self-reported number of drinks consumed during an average week in the past 30 days.

  3. Change in Baseline Daily Drinking from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported number of drinks consumed during an average week in the past 30 days.

  4. Change in Peak Drinking from Baseline to 1 Month Post Intervention

    Time frame: baseline, 1 month

    Self-reported max number of drinks consumed on a single occasion in the past 30 days.

  5. Change in Peak Drinking from Baseline to 7 Months Post Intervention

    Time frame: baseline, 7 months

    Self-reported max number of drinks consumed on a single occasion in the past 30 days.

  6. Change in Peak Drinking from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported max number of drinks consumed on a single occasion in the past 30 days.

  7. Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention

    Time frame: baseline, 1 month

    Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days

  8. Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention

    Time frame: baseline, 7 months

    Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days

  9. Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days

  10. Change in High Intensity Drinking from Baseline to 1 Month Post Intervention

    Time frame: baseline, 1 month

    Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days

  11. Change in High Intensity Drinking from Baseline to 7 Months Post Intervention

    Time frame: baseline, 7 months

    Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days

  12. Change in High Intensity Drinking from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days

  13. Change in Alcohol-Related Consequences from Baseline to 1 Month Post Intervention

    Time frame: baseline, 1 month

    Self-reported number of alcohol-related consequences in the past 30 days.

  14. Change in Alcohol-Related Consequences from Baseline to 7 Months Post Intervention

    Time frame: baseline, 7 months

    Self-reported number of alcohol-related consequences in the past 30 days.

  15. Change in Alcohol-Related Consequences from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported number of alcohol-related consequences in the past 30 days.

Secondary outcomes

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

    Time frame: baseline, 1 month

    Self-reported number of drinks parent would permit student to drink in the next year.

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

    Time frame: baseline, 7 months

    Self-reported number of drinks parent would permit student to drink in the next year.

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

    Time frame: baseline, 12 months

    Self-reported number of drinks parent would permit student to drink.

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

    Time frame: baseline, 1 month

    Self-reported frequency of parent communication in the past 3 months.

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

    Time frame: baseline, 7 months

    Self-reported frequency of parent communication in the past 3 months.

  6. Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention

    Time frame: baseline, 12 months

    Self-reported frequency of parent communication in the past 3 months.

Sponsors and collaborators

Lead sponsor

Loyola Marymount University

Other

Collaborators

  • Lehigh University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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