Underage DrinkingNCT05345951
Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use
A study testing e-PBI+ and e-PBI in people with Underage Drinking and Cannabis Use, run by Penn State University at 1 site in United States.
Trial summary
College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Drinking, Cannabis Use, Drinking, Teen
- What is being tested?
- e-PBI+ and e-PBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parent and teen both consent and complete baseline (forming a dyad testing unit)
Who cannot join
- Outside of the teen age range; both parent and teen do not consent and complete baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: A Randomized Clinical Trial: Examining a Brief Parent-intervention to Reduce College Student Drinking and Cannabis Use
College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).
Read the detailed description
College is a high-risk window for alcohol and cannabis use, with almost 80% of college students reporting consuming alcohol in the past year and more than 1 in 3 reporting heavy episodic drinking in the past month. A recent National College Health survey indicated that about 30% of students reported using cannabis weekly or more often. This is concerning considering present-day cannabis has an increased potency with tetrahydrocannabinol (THC) levels in cannabis in the US increasing over 200% since 1990. Additionally, availability has increased due to increased legalization in the US. Cannabis use is associated with a number of negative outcomes such as impaired memory and concentration, reduced impulse control, poor class attendance and lower academic performance, increased anxiety/depression, and increased impaired driving. Additionally, a number of studies have shown an increase in co-use of alcohol and cannabis (use of both substances in the same day) or simultaneously so their effects overlap, and studies show that these combined behaviors results in much greater harm than alcohol-only use. The proposed research will attempt to curb the alarming trends associated with alcohol and cannabis use by conducting a randomized controlled trial testing a modified version of the Turrisi and associates efficacious brief Parent-Based Intervention (e-PBI) that includes additional data-driven content for parents to have broader discussions about cannabis use (e-PBI+).
The design is a 3-arm (e-PBI+, e-PBI, Attention-Matched control) randomized controlled trial with 4 waves of data collection. The study will enroll an ethnically diverse sample of 900 parent-student dyads (N at final follow-up). Students will complete assessments of all the primary, secondary, and tertiary outcomes at five times: pre-intervention baseline, and 3-month, 6-month, and 9-month follow-ups as well as provide urine samples at 6-month to corroborate cannabis use reported on the timeline followback. Parents will complete a baseline and 3-month follow-up survey.
- Conditions
- Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking
- Being tested
- e-PBI+, e-PBI
- Medical subject headings
- Underage Drinking, Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-PBI+Behavioural
The e-PBI+ is a preventive parent-based intervention emphasizing parent-teen communication on drinking/risks of alcohol abuse, with the addition of data-driven cannabis content to guide parent communications with their students (e.g., cannabis content focusing on the endocannabinoid system; acute and chronic cannabis use effects on the brain, cognition, and development; THC potency in present-day cannabis; cannabis use effects on mental and physical health, including psychosis, depression, and anxiety; respiratory/cardiovascular/sleep problems; cannabidiol (CBD) content, myths; and cannabis effects on psychosocial function). Together the goals are to reduce alcohol and cannabis use in college students.
e-PBIBehavioural
The e-PBI is currently a model prevention resource at NIAAA's College Alcohol Intervention Matrix and the research was discussed in the most recent Surgeon General's Report as one of two prevention approaches that met the rigorous criteria to be considered "efficacious". The first section of the e-PBI provides an introduction to the problem of substance use. The second section focuses on specific skill building strategies that parents can use to improve communication channels with their teen. Third is a section that addresses peer influence and provides strategies for developing assertiveness. The fourth section is an in-depth discussion of underage drinking, physiological and psychological effects, mixing alcohol with other drugs, motives for why students drink and don't drink, warning signs, risky binge-type drinking, impaired driving, riding with impaired drivers, alcohol and sexual assault, and how to communicate about parents' experiences when they were young.
| Study group | Role | What they receive |
|---|---|---|
| e-PBI+ | Experimental | The e-PBI+ is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens, with additional content on cannabis use. Receives: Behavioral: e-PBI+ |
| e-PBI | Experimental | the e-PBI is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens. Receives: Behavioral: e-PBI |
| e-AC | No intervention | The e-AC is the attention matched control. They will receive general university-related materials to read, sections on parent and family resources (e.g., message from administrators, getting involved, academic calendar), advising, money matters, financial aid, campus life (arts, entertainment, housing, etc.), health and safety (health, counseling services, alcohol and drug laws). It is equivalent to the e-PBI+ and e-PBI on length of content and time to read. This group will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine Changes in Alcohol Use
A standard drink definition will be provided, indicating that a standard drink consists of 12 oz. of beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, or 1.5 oz. of hard liquor. Using the Timeline Followback (TLFB; Sobell \& Sobell, 1996), participants will indicate how many drinks they consumed on each day of the past three months. For days alcohol was consumed, participants will also note the number of hours spent drinking.
Measured: Baseline, 3 month, 6 month, 9 month
Examine Changes in Cannabis Use
Self-reported measures of retrospective cannabis use will be collected via the TLFB calendar with modifications that incorporate current methods of consumption (e.g., joint, blunt, pipe/bowl, bong, edible, vaporizer cartridges, concentrate [including wax, oil, rosin, capsules, and tinctures], and other) and amount (e.g., in grams/mg).
Measured: Baseline, 3 month, 6 month, 9 month
Secondary outcomes (3)
Examine Changes in Consequences of Alcohol Use
Alcohol-related consequences (e.g., said or done embarrassing things, blackout) from the past three months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, \& Colder, 2006). Response options will be measured on a 7-point scale ranging from (0) no, not in the past 3 months to (6) 11 or more times in the past 3 months.
Measured: Baseline, 3 month, 6 month, 9 month
Examine Changes in Consequences of Cannabis Use
Participants will be asked to report on the frequency of experiencing a variety of cannabis-related consequences (e.g., neglected obligations, driven a car high) within the past three months using the Marijuana Consequences Questionnaire (MACQ; Simons, Dvorak, Merrill, \& Read, 2012). Response options will be measured on a 7-point scale ranging from (0) no, not in the past 3 months to (6) 11 or more times in the past 3 months
Measured: Baseline, 3 month, 6 month, 9 month
Examine Changes in Co-Use of Alcohol and Cannabis Use
Days on the TLFB when participants report using both alcohol and cannabis will be identified as co-use days.
Measured: Baseline, 3 month, 6 month, 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start13 Jul 2023
- Primary completion31 May 2026
- Study completion31 May 2026
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
- Model description
- The first group receives the e-PBI; the second group receives the e-PBI+; and the third group is the attention-matched control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Turrisi, Penn State University
- Investigators
- Robert Turrisi, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345951
- Sponsor's protocol ID
- 226723
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial: Examining a Brief Parent-intervention to Reduce College Student Drinking and Cannabis Use
- ClinicalTrials.gov ID
- NCT05345951
- Acronym / sponsor ID
- 226723
- Conditions
- Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,980 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 26 Apr 2022 (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.
College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).
Detailed description
College is a high-risk window for alcohol and cannabis use, with almost 80% of college students reporting consuming alcohol in the past year and more than 1 in 3 reporting heavy episodic drinking in the past month. A recent National College Health survey indicated that about 30% of students reported using cannabis weekly or more often. This is concerning considering present-day cannabis has an increased potency with tetrahydrocannabinol (THC) levels in cannabis in the US increasing over 200% since 1990. Additionally, availability has increased due to increased legalization in the US. Cannabis use is associated with a number of negative outcomes such as impaired memory and concentration, reduced impulse control, poor class attendance and lower academic performance, increased anxiety/depression, and increased impaired driving. Additionally, a number of studies have shown an increase in co-use of alcohol and cannabis (use of both substances in the same day) or simultaneously so their effects overlap, and studies show that these combined behaviors results in much greater harm than alcohol-only use. The proposed research will attempt to curb the alarming trends associated with alcohol and cannabis use by conducting a randomized controlled trial testing a modified version of the Turrisi and associates efficacious brief Parent-Based Intervention (e-PBI) that includes additional data-driven content for parents to have broader discussions about cannabis use (e-PBI+).
The design is a 3-arm (e-PBI+, e-PBI, Attention-Matched control) randomized controlled trial with 4 waves of data collection. The study will enroll an ethnically diverse sample of 900 parent-student dyads (N at final follow-up). Students will complete assessments of all the primary, secondary, and tertiary outcomes at five times: pre-intervention baseline, and 3-month, 6-month, and 9-month follow-ups as well as provide urine samples at 6-month to corroborate cannabis use reported on the timeline followback. Parents will complete a baseline and 3-month follow-up survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The first group receives the e-PBI; the second group receives the e-PBI+; and the third group is the attention-matched control
| Arm | Type | Receives |
|---|---|---|
| e-PBI+ | Experimental | Behavioral: e-PBI+The e-PBI+ is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens, with additional content on cannabis use. |
| e-PBI | Experimental | Behavioral: e-PBIthe e-PBI is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens. |
| e-AC | No intervention | –The e-AC is the attention matched control. They will receive general university-related materials to read, sections on parent and family resources (e.g., message from administrators, getting involved, academic calendar), advising, money matters, financial aid, campus life (arts, entertainment, housing, etc.), health and safety (health, counseling services, alcohol and drug laws). It is equivalent to the e-PBI+ and e-PBI on length of content and time to read. This group will not receive an intervention. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Parent and teen both consent and complete baseline (forming a dyad testing unit)
Key exclusion criteria (1 listed)
- Outside of the teen age range; both parent and teen do not consent and complete baseline
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 |
|---|---|---|
| e-PBI+The e-PBI+ is a preventive parent-based intervention emphasizing parent-teen communication on drinking/risks of alcohol abuse, with the addition of data-driven cannabis content to guide parent communications with their students (e.g., cannabis content focusing on the endocannabinoid system; acute and chronic cannabis use effects on the brain, cognition, and development; THC potency in present-day cannabis; cannabis use effects on mental and physical health, including psychosis, depression, and anxiety; respiratory/cardiovascular/sleep problems; cannabidiol (CBD) content, myths; and cannabis effects on psychosocial function). Together the goals are to reduce alcohol and cannabis use in college students. | Behavioural | e-PBI+ |
| e-PBIThe e-PBI is currently a model prevention resource at NIAAA's College Alcohol Intervention Matrix and the research was discussed in the most recent Surgeon General's Report as one of two prevention approaches that met the rigorous criteria to be considered "efficacious". The first section of the e-PBI provides an introduction to the problem of substance use. The second section focuses on specific skill building strategies that parents can use to improve communication channels with their teen. Third is a section that addresses peer influence and provides strategies for developing assertiveness. The fourth section is an in-depth discussion of underage drinking, physiological and psychological effects, mixing alcohol with other drugs, motives for why students drink and don't drink, warning signs, risky binge-type drinking, impaired driving, riding with impaired drivers, alcohol and sexual assault, and how to communicate about parents' experiences when they were young. | Behavioural | e-PBI |
Primary outcome
Examine Changes in Alcohol Use
Time frame: Baseline, 3 month, 6 month, 9 month
A standard drink definition will be provided, indicating that a standard drink consists of 12 oz. of beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, or 1.5 oz. of hard liquor. Using the Timeline Followback (TLFB; Sobell \& Sobell, 1996), participants will indicate how many drinks they consumed on each day of the past three months. For days alcohol was consumed, participants will also note the number of hours spent drinking.
Examine Changes in Cannabis Use
Time frame: Baseline, 3 month, 6 month, 9 month
Self-reported measures of retrospective cannabis use will be collected via the TLFB calendar with modifications that incorporate current methods of consumption (e.g., joint, blunt, pipe/bowl, bong, edible, vaporizer cartridges, concentrate [including wax, oil, rosin, capsules, and tinctures], and other) and amount (e.g., in grams/mg).
3 secondary outcomes
Examine Changes in Consequences of Alcohol Use
Time frame: Baseline, 3 month, 6 month, 9 month
Examine Changes in Consequences of Cannabis Use
Time frame: Baseline, 3 month, 6 month, 9 month
Examine Changes in Co-Use of Alcohol and Cannabis Use
Time frame: Baseline, 3 month, 6 month, 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert Turrisi, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-PBI+ and e-PBI in people with Underage Drinking and Cannabis Use, run by Penn State 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Examine Changes in Alcohol Use (time frame: Baseline, 3 month, 6 month, 9 month). The study lists 2 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 23 Jul 2026.