Clinical trial NCT05345951: Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use
Official title: A Randomized Clinical Trial: Examining a Brief Parent-intervention to Reduce College Student Drinking and Cannabis Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Underage Drinking
Cannabis Use
Drinking, Teen
Drinking, College
College Drinking
Teen Drinking
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 2425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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+).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Examine Changes in Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
Secondary outcomes:
measure: Examine Changes in Consequences of Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Consequences of Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Co-Use of Alcohol and Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
Other outcomes:
measure: Examine Changes in Parental Communication
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in General Parental Practices
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Alcohol Use Motives
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Cannabis Use Motives
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Alcohol Use Expectancies
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Cannabis Use Expectancies
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Alcohol Use Willingness
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Cannabis Use Willingness
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Descriptive Norms of Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Descriptive Norms of Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Injunctive Norms of Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Peer Injunctive Norms of Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Parental Injunctive Norms of Alcohol Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Parental Injunctive Norms of Cannabis Use
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Self Regulation
timeFrame: Baseline, 3 month, 6 month, 9 month
measure: Examine Changes in Goal Setting
timeFrame: Baseline, 3 month, 6 month, 9 month
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Robert Turrisi, PhD
role: PRINCIPAL_INVESTIGATOR
References: