NCT04247191

Brief 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. 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,061

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

January 24, 2020

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 month, 6 month, 9 month, senior year college

Secondary Outcomes (3)

  • Examine Changes in Impaired Driving (IMPD) Behaviors

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Riding with Impaired Driver (RWID) Behaviors

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Consequences of Alcohol Use

    Baseline, 3 month, 6 month, 9 month

Other Outcomes (7)

  • Examine Changes in Parental Rules about Underage Drinking (Permissiveness)

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Parental Communication

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Alcohol Use Motives

    Baseline, 3 month, 6 month, 9 month

  • +4 more other outcomes

Study Arms (4)

P-Chat

EXPERIMENTAL

The P-Chat is a brief individually delivered intervention

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

Behavioral: PBI

P-Chat+

EXPERIMENTAL

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

Behavioral: P-Chat+

Control

NO INTERVENTION

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

Interventions

P-Chat+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.

P-Chat+
PBIBEHAVIORAL

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.

PBI

Eligibility Criteria

Age18 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Outside of the teen age range; both parent and teen do not consent and complete baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Underage DrinkingDriving Under the InfluenceAlcohol Drinking in College

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking BehaviorCriminal BehaviorDangerous Behavior

Study Officials

  • Robert Turrisi, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biobehavioral Health

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 29, 2020

Study Start

June 14, 2021

Primary Completion

April 16, 2025

Study Completion

April 16, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations