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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to reduce underage drinking among first-year college students. It compares various approaches, including an app providing personalized feedback to parents (PH+ PBI), email tips (PNF+ PBI), and a digital guidebook (SNMC+ PBI), to determine which most effectively encourages healthier attitudes and communication about alcohol. The trial aims to discover if these interventions can lead to less drinking and fewer alcohol-related issues for students. It seeks first-year college students at LMU or Lehigh University whose parent or guardian has an email address on file at their university. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could positively impact student health and well-being.

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 prior data suggests that this app-based intervention is safe for reducing underage drinking?

Research has shown that the Parent Handbook (PH+ PBI) has been used in past studies and is generally well-received. One study found it helped reduce heavy drinking and related problems among teens. It is designed to help parents communicate more effectively with their children about the risks of alcohol.

For the Personalized Normative Feedback (PNF+ PBI), research indicates that similar methods can successfully reduce drinking in college students. This approach is computer-based and provides participants with personalized information.

Regarding the Social Norms Marketing Campaign (SNMC+ PBI), evidence suggests these campaigns are safe and effectively engage parents. They offer tips and facts to help parents discuss alcohol use with their children.

Overall, these programs are non-invasive and focus on education and communication, making them expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these app-based interventions for underage drinking because they offer innovative and interactive ways to engage parents in reducing alcohol-related risks. The PNF+ PBI treatment uses a personalized app that tailors feedback and educational content to parents based on their quiz responses, helping them understand and address misconceptions about student drinking. Meanwhile, the SNMC+ PBI provides structured communications with factual insights and tips to encourage productive conversations between parents and their children. Unlike traditional methods that might rely on static educational materials, these approaches leverage technology to deliver dynamic and personalized support, potentially making them more effective in preventing underage drinking.

What evidence suggests that this trial's treatments could be effective for reducing underage drinking?

This trial will compare different app-based interventions designed to reduce underage drinking by involving parents. Research has shown that personalized apps can help young people drink less by correcting their misconceptions about peer drinking habits. Participants in this trial may receive the PNF+ PBI intervention, which uses an interactive app to provide personalized feedback and resources. Additionally, studies have demonstrated that social norms marketing campaigns, like the SNMC+ PBI intervention in this trial, effectively lower alcohol use by sharing accurate information about drinking habits and encouraging parent-child conversations. The PH+ PBI intervention, which includes the Parent Handbook, has shown a modest effect by offering detailed guidelines for handling alcohol-related issues and improving communication. Each method aims to involve parents in reducing underage drinking. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06871982?term=AREA%5BConditionSearch%5D(%22Underage%20Drinking%22)&rank=1

Study Details | NCT06871982 | Norms Re-education to ... The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131174/

A brief online parent-based intervention to reduce alcohol use ... This study is a formative assessment of REAL Parenting (RP): a brief, digital intervention for parents of high school students that encourages parent-teen ...

3. withpower.com withpower.com/trial/app-based-intervention-for-underage-drinking-73e47

App-Based Intervention for Underage Drinking 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250629/

Effects of the FITSTART+ PBI on drinking and negative ... This study evaluated FITSTART+, a parent-based intervention (PBI), for preventing risky drinking among first-year college students.

5. library.samhsa.gov library.samhsa.gov/product/take-action-prevent-underage-alcohol-use/pep22-03-10-004a

Take Action to Prevent Underage Alcohol Use This data visualization illustrates the steady decline of alcohol use amongst adolescents, informing parents/guardians and communities that taking action ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9157320/

A Parent-Based Intervention for Reducing High-risk Social ... The central goal of the proposed study is to develop, refine, and pilot a web-based PBI to reduce both high-risk social media cognitions and alcohol use among ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2701098/

A Randomized Trial of a Parent-Based Intervention on ... Turrisi and colleagues (2001) demonstrated the short-term efficacy of the PBI handbook approach in reducing heavy drinking and alcohol-related consequences ...

8. jahonline.org jahonline.org/article/S1054-139X(23)00493-7/pdf

Examination of Brief Parent-Based Interventions to Reduce ... Parents who are highly engaged with these interventions show less teen drinking and more declining riding with impaired drivers. Drunk driving (also ...