Evaluating Telehealth Delivery of Brief Alcohol Screening and Intervention for College Students

NCT ID: NCT06774300

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-07-31

Brief Summary

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.

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.

Conditions

Alcohol Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

BASICS

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

BASICS

Intervention Type: BEHAVIORAL

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.

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).

Group Type: ACTIVE_COMPARATOR

Online alcohol programming

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Houston

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Eric Pedersen

Associate Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric R Pedersen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Clayton Neighbors, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

University of Houston

Houston, Texas, United States

Countries

United States

Central Contacts

Eric R Pedersen, Ph.D.

Role: CONTACT

Eric.Pedersen@med.usc.edu

323-442-4046

Facility Contacts

Clayton Neighbors, Ph.D.

Role: primary

cneighbo@central.uh.edu

713-743-2255

Other Identifiers

R01AA031252

Identifier Type: NIH

Identifier Source: secondary_id

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R01AA031252

Identifier Type: NIH

Identifier Source: org_study_id

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