Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use

Study Overview
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Brief Summary
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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
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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 5 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, 9-month, and 12-month follow-ups as well as provide urine samples at 3-month and 9-month to corroborate cannabis use reported on the timeline followback. Parents will complete a baseline and 3-month follow-up survey.

Official Title
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A Randomized Clinical Trial: Examining a Brief Parent-intervention to Reduce College Student Drinking and Cannabis Use

Conditions
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Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking

Intervention / Treatment
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* Behavioral: e-PBI+
* Behavioral: e-PBI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-PBI+<br>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+<br>* The e-PBI+ is a preventive parent-based intervention emphasizing parent-teen communication on drinking/risks of alcohol abuse, with the addition of data-driven cannabis content to guide parent communications with their students (e.g., cannabis content focusing on the endocannabinoid system; acute and chronic cannabis use effects on the brain, cognition, and development; THC potency in present-day cannabis; cannabis use effects on mental and physical health, including psychosis, depression, and anxiety; respiratory/cardiovascular/sleep problems; cannabidiol (CBD) content, myths; and cannabis effects on psychosocial function). Together the goals are to reduce alcohol and cannabis use in college students.<br>|
| Experimental: e-PBI<br>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<br>* 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.<br>|
| No Intervention: e-AC<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 12 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, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 7-point scale ranging from (0) no, not in the past 3 months to (6) 11 or more times in the past 3 months. | Baseline, 3 month, 6 month, 9 month, 12 month | 
| Examine Changes in Consequences of Cannabis Use | Participants will be asked to report on the frequency of experiencing a variety of cannabis-related consequences (e.g., neglected obligations, driven a car high) within the past three months using the Marijuana Consequences Questionnaire (MACQ; Simons, Dvorak, Merrill, & Read, 2012). Response options will be measured on a 7-point scale ranging from (0) no, not in the past 3 months to (6) 11 or more times in the past 3 months | Baseline, 3 month, 6 month, 9 month, 12 month | 
| Examine Changes in Co-Use of Alcohol and Cannabis Use | Days on the TLFB when participants report using both alcohol and cannabis will be identified as co-use days. | Baseline, 3 month, 6 month, 9 month, 12 month |