App-Based Intervention for Underage Drinking

Overseen By Bradley Trager, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Loyola Marymount University

Disqualifiers: Age, College status, Residency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

2040 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PH+ PBI, PNF+ PBI, SNMC+ PBI for underage drinking?

Research shows that mobile apps can help reduce alcohol use among young people by increasing their knowledge about alcohol and reducing the number of drinks consumed. Apps like Ray's Night Out and others have shown promise in reducing alcohol-related harm and are considered user-friendly and accessible. ^{1 2 3 4 5}

Is the app-based intervention for underage drinking safe for young people?

The research does not provide specific safety data for the app-based intervention, but it suggests that these types of apps are generally well-received and can reduce alcohol-related harm among young people. ^{1 2 3 5 6}

How is the app-based intervention for underage drinking different from other treatments?

This app-based intervention is unique because it combines personalized feedback and social norms messaging with a mobile platform, making it easily accessible and engaging for young people. It uses technology to provide real-time risk assessments and tailored advice, which is different from traditional face-to-face interventions. ^{1 3 5 7 8}

Eligibility Criteria

This trial is for first-year college students aiming to reduce underage drinking. Parents of these students will participate in interventions without incentives. Students must be enrolled at one of the participating campuses and willing to have their alcohol use monitored.

Inclusion Criteria

I am a 17-20 year old incoming first-year student at LMU/Lehigh.

Parent/legal guardian with an email address on file with the university

A United States resident

Exclusion Criteria

I am either under 17 or over 20 years old.

Not an incoming first-year college student at LMU/Lehigh

Parent or legal guardian does not have an email address on file with the university

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Incoming first-year students complete an online baseline survey to assess alcohol use and related behaviors

1 week

1 online survey

Intervention

Parents receive access to their assigned program (PNF+ PBI, SNMC+ PBI, PH+ PBI, or no intervention) following the baseline survey

12 months

Ongoing access to intervention materials

Follow-up

Participants complete follow-up surveys to assess changes in alcohol use and related behaviors

12 months

3 follow-up surveys at 1, 6, and 12 months post-matriculation

Treatment Details

Interventions

• PH+ PBI
• PNF+ PBI
• SNMC+ PBI

Trial Overview The study tests three parent-based interventions: an app-based personalized feedback program (PNF+ PBI), an email campaign promoting healthy norms (SNMC+ PBI), and a Parent Handbook approach (PH+ PBI). The goal is to see which method best reduces student alcohol consumption.

Participant Groups

Group I: SNMC+ PBI Experimental Treatment 1 Intervention

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 II: PNF+ PBI Experimental Treatment 1 Intervention

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 III: No Intervention Active Control 1 Intervention

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

Group IV: PH+ PBI Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Loyola Marymount University

Lead Sponsor

Trials

9

Recruited

8,800+

Lehigh University

Collaborator

Trials

24

Recruited

6,800+

Findings from Research

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

In a study involving 672 participants using the Drink Less app, older users and those with post-16 educational qualifications showed higher engagement and were more likely to respond to follow-up assessments after one month.

While higher baseline alcohol consumption was linked to greater reductions in alcohol intake, engagement with the app did not correlate with the extent of alcohol reduction, indicating that simply using the app more did not necessarily lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Engagement, Response to Follow Up, and Extent of Alcohol Reduction in Users of a Smartphone App (Drink Less): Secondary Analysis of a Factorial Randomized Controlled Trial. Garnett, C., Perski, O., Tombor, I., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and outcomes of a mobile app targeting alcohol use in young people. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Risk Estimation Modeling and Feasibility Testing for a Mobile eHealth Intervention for Binge Drinking Among Young People: The D-ARIANNA (Digital-Alcohol RIsk Alertness Notifying Network for Adolescents and young adults) Project. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of a Mobile E-Health Intervention on Binge Drinking in Young People: The Digital-Alcohol Risk Alertness Notifying Network for Adolescents and Young Adults Project. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Linked randomised controlled trials of face-to-face and electronic brief intervention methods to prevent alcohol related harm in young people aged 14-17 years presenting to Emergency Departments (SIPS junior). [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effect of a smartphone intervention as a secondary prevention for use among university students with unhealthy alcohol use: randomised controlled trial. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Predictors of Engagement, Response to Follow Up, and Extent of Alcohol Reduction in Users of a Smartphone App (Drink Less): Secondary Analysis of a Factorial Randomized Controlled Trial. [2022]