Evaluating Telehealth Delivery of Brief Alcohol Screening and Intervention for College Students (Tele-BASICS)

This research study will test the efficacy of a telehealth version of the Brief Alcohol Screening and Intervention for College Students (BASICS), which is the gold standard prevention and intervention approach to target heavy alcohol use on college campuses across the United States.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Consumption
• Intervention / Treatment: Behavioral: BASICS; Behavioral: Online alcohol programming

Detailed Description

In this study, the researchers will evaluate the efficacy of a tele-BASICS approach utilizing the ZOOM application compared to in-person BASICS and a lower threshold treatment as usual intervention. Three hundred mandated and 300 volunteer students who report hazardous drinking will be recruited from two large universities and randomly assigned to a condition (in-person BASICS, Tele-BASICS, or treatment as usual). Follow-up assessments will occur 1-, 3-, 6-, and 12-months post-baseline. The significance of this research lies in the potential to maximize access to the highest standard of care by establishing support for easier access without sacrificing any central features of the traditional BASICS intervention. In addition, many universities pragmatically adapted existing in-person interventions to remote-telehealth approaches in response to the COVID pandemic but now have no scientific basis for determining whether transitioning back to in-person approaches would be beneficial.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric R Pedersen, Ph.D.; Phone Number: 323-442-4046; Email: Eric.Pedersen@med.usc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston
      • Contact: Clayton Neighbors, Ph.D.; Phone Number: 713-743-2255; Email: cneighbo@central.uh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• between 18 and 26 years of age
• fluent in understanding English
• a registered student at one of the two intervention sites
• adequate internet capabilities to support video-conferencing
• access to a webcam, which is a standard features of most laptops, mobile devices, and desktops
• engage in binge drinking (i.e., 4 or more standard drinks in a sitting for women or 5 or more standard drinks in a sitting for men) at least once in the past month (for the volunteer sample only)
• experienced at least one negative alcohol-related consequence in the previous month (mandated students would meet this due to receiving an alcohol sanction)
• reports a score of 2 or higher on questions about a) interest in reducing their drinking, or b) interest in not increasing their drinking.

Exclusion Criteria:

• not meeting inclusion criteria or unwillingness to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-person BASICS; This intervention conditions consist of a feedback interview with a trained facilitator. The feedback interview is a one-hour intervention based on the information provided during the baseline assessment. The content and process of the interview will be similar to methods developed and tested by Marlatt and colleagues and described in detail in the BASICS manual. Trained facilitators will meet individually with the students in-person and provide concrete personalized feedback regarding the following BASICS content: drinking patterns, drinking norms, risks, beliefs about alcohol and its effects, and protective behavioral strategies	Behavioral: BASICS; The intervention is the BASICS protocol outlined in the BASICS manual. It includes an online self-administered assessment and then delivery of a feedback session either in-person or over Zoom.
Experimental: Tele-BASICS; This intervention conditions consist of a feedback interview with a trained facilitator just like in the in-person BASICS condition. However, the feedback interview will be conducted over Zoom. Trained facilitators will meet individually with the students using video conferencing software and provide concrete personalized feedback regarding the following BASICS content: drinking patterns, drinking norms, risks, beliefs about alcohol and its effects, and protective behavioral strategies	Behavioral: BASICS; The intervention is the BASICS protocol outlined in the BASICS manual. It includes an online self-administered assessment and then delivery of a feedback session either in-person or over Zoom.
Active Comparator: Treatment as usual; The control group for this study will receive the universities' online program that is typically given to students as a first line sanction. The program is informed by BASICS, but includes no facilitator, either in-person or online. It is primarily text-based with some graphics. It contains alcohol information (physiological reactions at specific blood alcohol levels, safe drinking tips, signs of alcohol poisoning), descriptions of alcohol laws and policies (on campus, minor in possession laws), campus and national resources (e.g., contact information for crisis hotlines and student counseling center), and personalized feedback (e.g., number of calories consumed via alcoholic drinks, money spent on alcohol).	Behavioral: Online alcohol programming; This is a control intervention that is used as the first-line sanction for students at the two universities. It is an online program, informed by BASICS content, but contains no facilitator and is self-directed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use	Quantity and frequency of alcohol use in the past month (i.e., how many days drank and how many drinks per occasion). Assessed at baseline and then 1-, 3-, 6-, and 12-months post-baseline.	Assessed over the course of 12 months
Alcohol-related consequences	Young Adult Alcohol Consequences Questionnaire assesses past month consequences from alcohol use. Higher scores indicate more endorsement of the 24 consequences (yes/no) items on the scale. Outcome assessed at baseline and then 1-, 3-, 6-, and 12-months post-baseline	Assessed over the course of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rates	We will evaluate completion rates of the each of the three programs tested in this study. This will be indicated by whether participants attended their scheduled BASICS session or fully completed their online treatment as ususal alcohol program	One time assessment at end of program, after 1 session is completed 1 to 2 weeks post-baseline

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Houston
• Investigators: Principal Investigator: Eric R Pedersen, Ph.D., University of Southern California; Principal Investigator: Clayton Neighbors, Ph.D., University of Houston

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: alcohol; drinking; brief intervention; teleheath
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: R01AA031252 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be uploaded to the NIAAA Data Archive (NIAAADA) consistent with NIAAA protocols and requirements. Data will be shared to the repository for other researchers to access in non-identifiable form. Participants will be informed that their anonymous data will be uploaded to the NIAAADA.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No