Health TrialsbyHealthPanel

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

ConditionUnderage Drinking
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-20
SponsorLoyola Marymount University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,040 Participants
are divided into 4 treatment groups
Group A: PNF+ PBIExperimental treatment 1 intervention
Group B: SNMC+ PBIExperimental treatment 1 intervention
Group C: PH+ PBIActive comparator 1 intervention
Group D: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, 3 months
2

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.

Time frame
baseline, 7 months
3

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.

Time frame
baseline, 12 months
4

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.

Time frame
baseline, 1 month

Secondary outcomes

1

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

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

Time frame
baseline, 1 month
2

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

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

Time frame
baseline, 7 months
3

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

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

Time frame
baseline, 12 months
4

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

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

Time frame
baseline, 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loyola Marymount University

Lead sponsor

Lehigh University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: