Underage DrinkingNCT06871982
Norms Re-education to Promote Engagement in Parent-based Interventions
A study testing PNF+ PBI, SNMC+ PBI and PH+ PBI in people with Underage Drinking, run by Loyola Marymount University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Drinking
- What is being tested?
- PNF+ PBI, SNMC+ PBI and PH+ PBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Norms Re-education to Promote Engagement in Parent-based Interventions: A Type 1 Implementation-effectiveness 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.
Read the detailed description
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
- Underage Drinking
- Being tested
- PNF+ PBI, SNMC+ PBI, PH+ PBI
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF+ PBIBehavioural
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+ PBIBehavioural
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+ PBIBehavioural
Also called Digitized Parent Handbook
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.
| Study group | Role | What they receive |
|---|---|---|
| PNF+ PBI | Experimental | 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. Receives: Behavioral: PNF+ PBI |
| SNMC+ PBI | Experimental | 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. Receives: Behavioral: SNMC+ PBI |
| PH+ PBI | Active comparator | 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. Receives: Behavioral: PH+ PBI |
| No Intervention | No intervention | In the control condition, no parent-based intervention content is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months
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.
Measured: baseline, 7 months
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.
Measured: baseline, 12 months
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.
Measured: baseline, 1 month
Change in Peak Drinking from Baseline to 7 Months Post Intervention
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Measured: baseline, 7 months
Change in Peak Drinking from Baseline to 12 Months Post Intervention
Self-reported max number of drinks consumed on a single occasion in the past 30 days.
Measured: baseline, 12 months
Change in Heavy Episodic Drinking from Baseline to 1 Month Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Measured: baseline, 1 month
Change in Heavy Episodic Drinking from Baseline to 7 Months Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Measured: baseline, 7 months
Change in Heavy Episodic Drinking from Baseline to 12 Months Post Intervention
Self-reported number of times 4/5 drinks (female/male) were consumed in a 2-hour period in the past 30 days
Measured: baseline, 12 months
Change in High Intensity Drinking from Baseline to 1 Month Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Measured: baseline, 1 month
Change in High Intensity Drinking from Baseline to 7 Months Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Measured: baseline, 7 months
Change in High Intensity Drinking from Baseline to 12 Months Post Intervention
Self-reported number of times 8/10 drinks (female/male) were consumed on a single occasion in the past 30 days
Measured: baseline, 12 months
Change in Alcohol-Related Consequences from Baseline to 1 Month Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Measured: baseline, 1 month
Change in Alcohol-Related Consequences from Baseline to 7 Months Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Measured: baseline, 7 months
Change in Alcohol-Related Consequences from Baseline to 12 Months Post Intervention
Self-reported number of alcohol-related consequences in the past 30 days.
Measured: baseline, 12 months
Secondary outcomes (6)
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.
Measured: baseline, 1 month
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.
Measured: baseline, 7 months
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.
Measured: baseline, 12 months
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.
Measured: baseline, 1 month
Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention
Self-reported frequency of parent communication in the past 3 months.
Measured: baseline, 7 months
Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention
Self-reported frequency of parent communication in the past 3 months.
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start11 Jun 2026
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underage DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola Marymount University
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871982
- Sponsor's protocol ID
- 1R01AA030904-01
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norms Re-education to Promote Engagement in Parent-based Interventions: A Type 1 Implementation-effectiveness Trial
- ClinicalTrials.gov ID
- NCT06871982
- Acronym / sponsor ID
- 1R01AA030904-01
- Conditions
- Underage Drinking
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- Loyola Marymount UniversityUniversity, hospital or other
- Collaborators
- Lehigh University
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PNF+ PBI | Experimental | Behavioral: PNF+ PBIThis 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. |
| SNMC+ PBI | Experimental | Behavioral: SNMC+ PBIThis 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. |
| PH+ PBI | Active comparator | Behavioral: PH+ PBIThis 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. |
| No Intervention | No intervention | –In the control condition, no parent-based intervention content is provided. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF+ PBIParents 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. | Behavioural | PNF+ PBI |
| SNMC+ PBIParents 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. | Behavioural | SNMC+ PBI |
| PH+ PBIAlso: Digitized Parent HandbookParents 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. | Behavioural | PH+ PBI |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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.
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.
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.
6 secondary outcomes
Change in Perceived Parental Approval of Underage Drinking from Baseline to 1 Month Post Intervention
Time frame: baseline, 1 month
Change in Perceived Parental Approval of Underage Drinking from Baseline to 7 Months Post Intervention
Time frame: baseline, 7 months
Change in Perceived Parental Approval of Underage Drinking from Baseline to 12 Months Post Intervention
Time frame: baseline, 12 months
Change in Perceived Frequency of Parent Communication from Baseline to 1 Month Post Intervention
Time frame: baseline, 1 month
Change in Perceived Frequency of Parent Communication from Baseline to 7 Months Post Intervention
Time frame: baseline, 7 months
Change in Perceived Frequency of Parent Communication from Baseline to 12 Months Post Intervention
Time frame: baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF+ PBI, SNMC+ PBI and PH+ PBI in people with Underage Drinking, run by Loyola Marymount University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline Daily Drinking from Baseline to 1 Month Post Intervention (time frame: baseline, 3 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.