NCT06774300

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.

Trial Health

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Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Jul 2030

First Submitted

Initial submission to the registry

December 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

December 31, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

alcoholdrinkingbrief interventionteleheath

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Completion rates

    One time assessment at end of program, after 1 session is completed 1 to 2 weeks post-baseline

Study Arms (3)

In-person BASICS

EXPERIMENTAL

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

Tele-BASICS

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

BASICSBEHAVIORAL

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.

In-person BASICSTele-BASICS

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.

Treatment as usual

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Eric R Pedersen, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR
  • Clayton Neighbors, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric R Pedersen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It will be clear to participants and facilitators which intervention condition participants are in. Therefore, masking will be conducted at the data analyses level
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 14, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

July 31, 2030

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations