Telehealth Alcohol Intervention for Alcohol Consumption

(Tele-BASICS Trial)

Overseen By Eric R Pedersen, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Not meeting inclusion criteria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a telehealth version of the BASICS program can help college students reduce heavy drinking, similar to the in-person version. BASICS is a well-known approach that provides feedback on drinking habits and strategies to drink less. The trial includes three groups: one receives in-person sessions, another participates via Zoom, and the last uses an online program without a facilitator. Students who drink heavily (at least four to five drinks in one sitting) and have recently faced negative effects from drinking may be a good fit. As an unphased trial, this study offers students an opportunity to explore innovative ways to manage drinking habits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this telehealth intervention is safe for college students?

Research has shown that the Brief Alcohol Screening and Intervention for College Students (BASICS) helps college students make better drinking choices and effectively reduces risky drinking habits.

The Tele-BASICS version, conducted through web conferencing, has been tested for its effectiveness with college students. Studies found that students generally appreciated it, indicating the program's usefulness and positive reception.

For the in-person BASICS, research highlights its success in helping students understand the real dangers of excessive drinking. The program provides personalized feedback based on each student's drinking habits, which has been shown to reduce problem drinking.

Overall, both the online and in-person versions of BASICS have been well-received by students, with no major safety issues reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore new ways to deliver the BASICS intervention to reduce alcohol consumption. Traditionally, interventions like BASICS are conducted in-person, but the Tele-BASICS approach uses video conferencing, making it more accessible for students who may not be able to attend in-person sessions. This telehealth method maintains the personal interaction with a trained facilitator, which is crucial for providing personalized feedback on drinking habits, but offers the flexibility and convenience of a remote session. This could potentially broaden the reach of effective alcohol interventions to more students, which is why researchers are keenly interested in seeing the results.

What evidence suggests that this trial's treatments could be effective for reducing alcohol consumption?

Studies have shown that the Brief Alcohol Screening and Intervention for College Students (BASICS) program effectively helps college students reduce their alcohol consumption. In this trial, participants will join different arms to evaluate BASICS's effectiveness. The in-person BASICS arm significantly reduces drinking over time, with students consuming less alcohol and encountering fewer problems. Meanwhile, the Tele-BASICS arm, delivered through video calls, effectively reduces risky drinking habits. Overall, both methods in this trial aim to help students make better choices about alcohol and reduce harmful drinking patterns. ^{2 3 6 7 8}

Who Is on the Research Team?

Eric R Pedersen, Ph.D.

Principal Investigator

University of Southern California

Clayton Neighbors, Ph.D.

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for college students who engage in heavy alcohol use. Specific eligibility details are not provided, but typically participants must be of legal drinking age and enrolled in a participating college.

Inclusion Criteria

A registered student at one of the two intervention sites

Access to a webcam, which is a standard feature of most laptops, mobile devices, and desktops

Experienced at least one negative alcohol-related consequence in the previous month (mandated students would meet this due to receiving an alcohol sanction)

Exclusion Criteria

I do not meet the study requirements or do not want to join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person BASICS, Tele-BASICS, or treatment as usual intervention

1-2 weeks

1 session (in-person or virtual)

Follow-up

Participants are monitored for alcohol-related consequences and alcohol use

12 months

Assessments at 1, 3, 6, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• BASICS

Trial Overview

The study is testing the effectiveness of an online version of BASICS (Brief Alcohol Screening and Intervention for College Students) delivered through telehealth to reduce heavy alcohol consumption among college students.

How Is the Trial Designed?

Group I: Tele-BASICS Experimental Treatment 1 Intervention

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 II: In-person BASICS Experimental Treatment 1 Intervention

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 III: Treatment as usual Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Telemedicine, specifically through videoconferencing, is being used to effectively deliver motivational enhancement therapy to at-risk alcohol users in rural areas, where access to treatment is often limited.

This approach not only addresses the lack of evidence-based substance abuse treatment in rural communities but also tailors interventions to the specific needs of at-risk groups, enhancing the potential for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. Staton-Tindall, M., Wahler, E., Webster, JM., et al.[2021]

A smartphone application designed to help reduce unhealthy alcohol use was found to be acceptable and useful among 130 adults, with significant reductions in weekly drinking (from 15.0 to 10.9 drinks/week) and binge drinking (from 95.4% to 64.3%) after 3 months.

Participants who used the application more than once reported a 30% reduction in weekly alcohol consumption, indicating that increased engagement with the app may lead to better drinking outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. Bertholet, N., Daeppen, JB., McNeely, J., et al.[2022]

The telehealth in-home-messaging-device was developed to enhance access to treatment for patients with substance use disorders, addressing barriers like transportation and treatment availability in rural areas.

A pilot study with six outpatient veterans showed that the Substance Use Disorder telehealth management program was well-received, being considered acceptable, easy to use, and helpful in managing their substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an in-home telehealth program for outpatient veterans with substance use disorders. Santa Ana, EJ., Stallings, DL., Rounsaville, BJ., et al.[2019]

In a study of 4121 patients receiving alcohol use disorder treatment via telehealth, 50.1% retained treatment for 90 days, indicating a significant level of engagement with the program.

Patients showed a substantial reduction in daily estimated peak blood alcohol concentration (BAC), decreasing from a mean of 0.092 on day 1 to 0.038 by day 90, demonstrating the efficacy of telehealth in promoting drinking reductions across various patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment retention and reductions in blood alcohol concentration (BAC) during the first 90 days of a telehealth program for alcohol use disorder. Hallgren, KA., Galloway, GP., Witkiewitz, K., et al.[2023]

The interactive, video-enhanced e-SBI (electronic screening and brief intervention) was found to be highly acceptable among pregnant women, with participants rating it as easy to use and helpful, scoring between 4.7 to 5.0 on a 5-point scale.

The pilot trial suggested medium-sized effects of the e-SBI on achieving 90-day period prevalence abstinence from alcohol and improved pregnancy outcomes, with odds ratios of 3.4 and 3.3 respectively, indicating potential benefits that warrant further investigation in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. Ondersma, SJ., Beatty, JR., Svikis, DS., et al.[2018]

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov/articles/PMC8942086/

Brief Alcohol Screening and Intervention for Community ...

Preliminary evidence does suggest BASICCS shows promise in reducing alcohol use and consequences. Technology-based platforms could be a viable prevention ...

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A brief motivational intervention for high-risk college students that uses alcohol screening and feedback to reduce problem, excessive, and binge drinking.

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At approximately 12 months, students receiving BASICS had a significant reduction in alcohol consumption (difference between means = −1.50 ...

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crimesolutions.ojp.gov

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This is a preventive intervention designed to help college students make better decisions about alcohol use. The program is rated Effective.

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Brief Alcohol Screening and Intervention for College ...

This qualitative study explored the experiences of 13 mental health professionals who use the BASICS intervention. Themes emerged around the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2701092/

Alcohol Screening and Brief Intervention in a College Student ...

This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students ...

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vtechworks.lib.vt.edu

vtechworks.lib.vt.edu/server/api/core/bitstreams/128f4a06-5249-4f93-86bc-104affb274cb/content

Brief Alcohol Screening and Intervention for College Students ...

Data from the National Survey on Drug Use and Health. (NSDUH) and the Monitoring the Future survey (MTF) reveals roughly 65% of college students.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04052386

Brief Alcohol Screening for Community College Students ...

Investigators adapted BASICS (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and ...