NCT05345951

Brief 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). 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+).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,425

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jul 2026

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

April 20, 2022

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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).

    Baseline, 3 month, 6 month, 9 month

Secondary Outcomes (3)

  • Examine Changes in Consequences of Alcohol Use

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Consequences of Cannabis Use

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Co-Use of Alcohol and Cannabis Use

    Baseline, 3 month, 6 month, 9 month

Other Outcomes (16)

  • Examine Changes in Parental Communication

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in General Parental Practices

    Baseline, 3 month, 6 month, 9 month

  • Examine Changes in Alcohol Use Motives

    Baseline, 3 month, 6 month, 9 month

  • +13 more other outcomes

Study Arms (3)

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.

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.

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.

Interventions

e-PBIBEHAVIORAL

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.

e-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

RECRUITING

MeSH Terms

Conditions

Underage DrinkingAlcohol Drinking in College

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Officials

  • Robert Turrisi, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Turrisi, PhD

CONTACT

Sarah Ackerman, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The first group receives the e-PBI; the second group receives the e-PBI+; and the third group is the attention-matched control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biobehavioral Health

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

July 13, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations