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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-31

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Digitally Prompted Parenting: A Text Message Parent-Based Alcohol Intervention for Incoming College Students

NCT06861660

Underage Drinking

ENROLLING_BY_INVITATION NA

Brief Web-Based Alcohol Reduction Intervention for Undergraduates

NCT01694082

Alcohol Use Heavy Drinking Negative Consequences of Alcohol Use

COMPLETED NA

Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study

NCT04549454

Alcohol Drinking Alcohol Problem Drinking Parenting

COMPLETED NA

Multi-Component Breath Alcohol Intervention Phase 3

NCT06994962

Alcohol Use Alcohol Drinking Drinking Behavior

RECRUITING NA

Multi-Component Breath Alcohol Intervention

NCT06124898

Alcohol Use Alcohol Drinking Drinking Behavior

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Underage Drinking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PNF+ PBI

Intervention Type 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

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.

Group Type EXPERIMENTAL

SNMC+ PBI

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

PH+ PBI

Intervention Type 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.

No Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Digitized Parent Handbook

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

17 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes