Underage DrinkingNCT04247191
Parent Intervention to Reduce College Student Drinking and Consequences
A study testing P-Chat, PBI and P-Chat+ in people with Underage Drinking and Driving Under the Influence, run by Penn State University at 1 site in United States.
Trial summary
College students' alcohol use continues to be a major public health problem. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. 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, Driving Under the Influence, Drinking, Teen
- What is being tested?
- P-Chat, PBI and P-Chat+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,061 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 16 Apr 2025
- 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: Examining a Brief Parent Intervention to Reduce College Student Drinking and Consequences
College students' alcohol use continues to be a major public health problem. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. Both college health administrators and parents have requested parent-based interventions (PBIs), and parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective 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 PBI that includes additional content for parents to establish clear lines of communication around the important topic of permissiveness (referred to as P-Chat).
Read the detailed description
High-risk drinking and the associated consequences continue to be significant problems among college students. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. These concerns are further magnified by reports showing: 1) younger drivers are overrepresented in fatal crashes involving impaired drivers; 2)~1 in 6 fatalities are passengers (riders with the impaired drivers; RWID); and 3) although over 1.3 million drivers in the U.S. are arrested for impaired driving annually, they only represent 1% of the estimated 121 million self-reported episodes of impaired driving each year. Despite the benefits noted for the PBI, the investigators' recent NIAAA funded research examining parenting throughout college identified associations between specific parenting behaviors and risky drinking and consequences among students that are not adequately addressed. This research revealed several important trends: 1) many parents allow their teens to drink alcohol in an attempt to take the mystery away and provide opportunities to teach them safer drinking practices; 2) this "parental permissiveness" toward underage drinking, even though it was intended to be protective by parents, had the opposite effect and was significantly associated with increased risky drinking and consequences throughout college even when taking into account other critical factors (e.g., peer norms); 3) even small increases in parental permissiveness translated into students experiencing 4-5 more consequences per year; and 4) the effects of this parental permissiveness was not attenuated by other positive parenting behaviors (e.g., communication, monitoring, modeling). In response to these findings and the initial pilot study showing parents were initially reluctant to change their permissiveness when simply provided with the information about how it was associated with risky student drinking, the investigators embarked on a new endeavor in college student parent intervention research. The investigators developed a brief 15-20 minute intervention (P-Chat) that uses principles of Motivational Interviewing (MI) to reduce defensiveness and modify parents' motives (and behaviors) to change parental permissiveness, and in turn, reduce students' risky drinking and consequences. The investigators have also conducted a pilot randomized controlled trial (RCT) study to demonstrate ability to implement the P-Chat with fidelity; modify parents' willingness to change; and change parents' permissive behaviors. The pilot data provides evidence that the P-Chat intervention has the potential to substantially improve the public health impact of PBIs. The proposed research will examine the P-Chat as a stand-alone intervention and also as an add-on in combination with the original PBI to evaluate the best practice for implementation in a RCT using a rigorous study design.
The primary design is a four-arm randomized control trial with 4 waves of data collection (P-Chat, P-Chat+, PBI Only, and assessment only control). The study will enroll an ethnically diverse sample of 900 parent-student dyads. Students will complete assessments of all the primary, secondary, and tertiary outcomes at four times: pre-intervention baseline and 3-month, 6-month, and 9-month follow-ups. To maximize the diversity of the sample, the investigators are oversampling for 30% racial/ethnic minorities, free of sample bias.
The continuation of the study is to assess the long-term effects of the parent interventions in the 4th (senior) year of college among participants in Cohort 1. Student participants will complete an online survey once during their senior year of college.
- Being tested
- P-Chat, PBI, P-Chat+
- Medical subject headings
- Underage Drinking, Driving Under the Influence, Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-ChatBehavioural
The P-Chat is a brief individually delivered intervention based on the principles of Motivational Interviewing (MI) and focuses on increasing parents' motivation to reduce permissiveness toward underage alcohol use while reducing defensiveness and barriers to implementing these rules with their teen.
PBIBehavioural
The 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 the two prevention approaches that met the rigorous criteria to be considered "efficacious". The first section of the 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.
P-Chat+Behavioural
The P-Chat+ is a combination of the P-Chat and PBI described above. Parents in this arm of the study will receive both interventions.
| Study group | Role | What they receive |
|---|---|---|
| P-Chat | Experimental | The P-Chat is a brief individually delivered intervention Receives: Behavioral: P-Chat |
| PBI | Experimental | The PBI is a handbook developed by the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens Receives: Behavioral: PBI |
| P-Chat+ | Experimental | The P-Chat+ is a combination of the P-Chat and PBI described above. Receives: Behavioral: P-Chat+ |
| Control | No intervention | This group will only complete assessments and will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine Changes in Peak 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. Peak alcohol use was assessed using data from the Timeline Followback and indicates the highest number of drinks a participant reported consuming across the 90 day period.
Measured: Baseline, 3 month, 6 month, 9 month, senior year college
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 13-point scale ranging from 0 (No, or not in the past 3 months) to 12 (12 or more times).
Measured: Baseline, 3 month, 6 month, 9 month
Secondary outcomes (2)
Examine Changes in Impaired Driving (IMPD) Behaviors
Participants will indicate the number of times they drove a vehicle after using alcohol in the past 3 months. Response options will be measured on a 13-point scale ranging from 0 (No, or not in the past 3 months) to 12 (12 or more times).
Measured: Baseline, 3 month, 6 month, 9 month
Examine Changes in Riding with Impaired Driver (RWID) Behaviors
Participants will indicate the number of times they declined a ride from a driver that consumed alcohol in the past 3 months. Response options will be measured on a 13-point scale ranging from 0 (No, or not in the past 3 months) to 12 (12 or more times).
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 posted29 Jan 2020
- Study start14 Jun 2021
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Why it stopped: In order to continue the study, we needed a continuation. We applied for the continuation but it was not funded. We completed the original aims, we were not able to follow the participants further, so the study was terminated.
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 PBI parent intervention; the second group receives the P-Chat intervention; the third group receive the P-Chat+ intervention; and the fourth group is an assessment-only control.
- Masking
- None (open label)
- Enrolment
- 2,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- 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
- NCT04247191
- Sponsor's protocol ID
- 2R01AA012529-14
- Other IDs
- R01AA012529
- Status last verified
- May 2026
- First submitted
- 24 Jan 2020
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Brief Parent Intervention to Reduce College Student Drinking and Consequences
- ClinicalTrials.gov ID
- NCT04247191
- Acronym / sponsor ID
- 2R01AA012529-14
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In order to continue the study, we needed a continuation. We applied for the continuation but it was not funded. We completed the original aims, we were not able to follow the participants further, so the study was terminated.
- Enrolment
- 2,061 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 29 Jan 2020 (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' alcohol use continues to be a major public health problem. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. Both college health administrators and parents have requested parent-based interventions (PBIs), and parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective 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 PBI that includes additional content for parents to establish clear lines of communication around the important topic of permissiveness (referred to as P-Chat).
Detailed description
High-risk drinking and the associated consequences continue to be significant problems among college students. Among the many consequences of this risky behavior are impaired driving and impaired passenger fatalities. These concerns are further magnified by reports showing: 1) younger drivers are overrepresented in fatal crashes involving impaired drivers; 2)~1 in 6 fatalities are passengers (riders with the impaired drivers; RWID); and 3) although over 1.3 million drivers in the U.S. are arrested for impaired driving annually, they only represent 1% of the estimated 121 million self-reported episodes of impaired driving each year. Despite the benefits noted for the PBI, the investigators' recent NIAAA funded research examining parenting throughout college identified associations between specific parenting behaviors and risky drinking and consequences among students that are not adequately addressed. This research revealed several important trends: 1) many parents allow their teens to drink alcohol in an attempt to take the mystery away and provide opportunities to teach them safer drinking practices; 2) this "parental permissiveness" toward underage drinking, even though it was intended to be protective by parents, had the opposite effect and was significantly associated with increased risky drinking and consequences throughout college even when taking into account other critical factors (e.g., peer norms); 3) even small increases in parental permissiveness translated into students experiencing 4-5 more consequences per year; and 4) the effects of this parental permissiveness was not attenuated by other positive parenting behaviors (e.g., communication, monitoring, modeling). In response to these findings and the initial pilot study showing parents were initially reluctant to change their permissiveness when simply provided with the information about how it was associated with risky student drinking, the investigators embarked on a new endeavor in college student parent intervention research. The investigators developed a brief 15-20 minute intervention (P-Chat) that uses principles of Motivational Interviewing (MI) to reduce defensiveness and modify parents' motives (and behaviors) to change parental permissiveness, and in turn, reduce students' risky drinking and consequences. The investigators have also conducted a pilot randomized controlled trial (RCT) study to demonstrate ability to implement the P-Chat with fidelity; modify parents' willingness to change; and change parents' permissive behaviors. The pilot data provides evidence that the P-Chat intervention has the potential to substantially improve the public health impact of PBIs. The proposed research will examine the P-Chat as a stand-alone intervention and also as an add-on in combination with the original PBI to evaluate the best practice for implementation in a RCT using a rigorous study design.
The primary design is a four-arm randomized control trial with 4 waves of data collection (P-Chat, P-Chat+, PBI Only, and assessment only control). The study will enroll an ethnically diverse sample of 900 parent-student dyads. Students will complete assessments of all the primary, secondary, and tertiary outcomes at four times: pre-intervention baseline and 3-month, 6-month, and 9-month follow-ups. To maximize the diversity of the sample, the investigators are oversampling for 30% racial/ethnic minorities, free of sample bias.
The continuation of the study is to assess the long-term effects of the parent interventions in the 4th (senior) year of college among participants in Cohort 1. Student participants will complete an online survey once during their senior year of college.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The first group receives the PBI parent intervention; the second group receives the P-Chat intervention; the third group receive the P-Chat+ intervention; and the fourth group is an assessment-only control.
| Arm | Type | Receives |
|---|---|---|
| P-Chat | Experimental | Behavioral: P-ChatThe P-Chat is a brief individually delivered intervention |
| PBI | Experimental | Behavioral: PBIThe PBI is a handbook developed by the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
| P-Chat+ | Experimental | Behavioral: P-Chat+The P-Chat+ is a combination of the P-Chat and PBI described above. |
| Control | No intervention | –This group will only complete assessments and will not receive any 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 |
|---|---|---|
| P-ChatThe P-Chat is a brief individually delivered intervention based on the principles of Motivational Interviewing (MI) and focuses on increasing parents' motivation to reduce permissiveness toward underage alcohol use while reducing defensiveness and barriers to implementing these rules with their teen. | Behavioural | P-Chat |
| PBIThe 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 the two prevention approaches that met the rigorous criteria to be considered "efficacious". The first section of the 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 | PBI |
| P-Chat+The P-Chat+ is a combination of the P-Chat and PBI described above. Parents in this arm of the study will receive both interventions. | Behavioural | P-Chat+ |
Primary outcome
Examine Changes in Peak Alcohol Use
Time frame: Baseline, 3 month, 6 month, 9 month, senior year college
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. Peak alcohol use was assessed using data from the Timeline Followback and indicates the highest number of drinks a participant reported consuming across the 90 day period.
Examine Changes in Consequences of Alcohol Use
Time frame: Baseline, 3 month, 6 month, 9 month
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 13-point scale ranging from 0 (No, or not in the past 3 months) to 12 (12 or more times).
2 secondary outcomes
Examine Changes in Impaired Driving (IMPD) Behaviors
Time frame: Baseline, 3 month, 6 month, 9 month
Examine Changes in Riding with Impaired Driver (RWID) Behaviors
Time frame: Baseline, 3 month, 6 month, 9 month
Results and safety
The study was stopped early (reason given: In order to continue the study, we needed a continuation. We applied for the continuation but it was not funded. We completed the original aims, we were not able to follow the participants further, so the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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 P-Chat, PBI and P-Chat+ in people with Underage Drinking and Driving Under the Influence, 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: stopped early, as of the sponsor's last update on 28 May 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 was stopped early (reason given: In order to continue the study, we needed a continuation. We applied for the continuation but it was not funded. We completed the original aims, we were not able to follow the participants further, so the study was terminated.). Results are not available in the source record.
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 Peak Alcohol Use (time frame: Baseline, 3 month, 6 month, 9 month, senior year college). 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 28 May 2026.