Parent Intervention to Reduce College Student Drinking and Consequences

NCT ID: NCT04247191

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2061 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2028-05-31

Brief Summary

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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

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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 and one year later. Student participants will complete assessments twice: once during their senior year of college and once one year later after transitioning from college. Assessments will include online survey and the Alcohol Use Disorder (AUD) module of the Structured Clinical Interview for DSM-5 (SCID-5) interview at both time points.

Conditions

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Underage Drinking Driving Under the Influence Drinking, Teen Drinking, College

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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P-Chat

The P-Chat is a brief individually delivered intervention

Group Type EXPERIMENTAL

P-Chat

Intervention Type BEHAVIORAL

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.

PBI

The PBI is a handbook developed by the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens

Group Type EXPERIMENTAL

PBI

Intervention Type BEHAVIORAL

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+

The P-Chat+ is a combination of the P-Chat and PBI described above.

Group Type EXPERIMENTAL

P-Chat+

Intervention Type BEHAVIORAL

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.

Control

This group will only complete assessments and will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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P-Chat

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.

Intervention Type BEHAVIORAL

PBI

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parent and teen both consent and complete baseline (forming a dyad testing unit);

Exclusion Criteria

* Outside of the teen age range; both parent and teen do not consent and complete baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Robert Turrisi

Professor of Biobehavioral Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Turrisi, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Penn State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA012529

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01AA012529-14

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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