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临床试验/NCT06774300
NCT06774300招募中不适用

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

University of Southern California2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Alcohol use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

It will be clear to participants and facilitators which intervention condition participants are in. Therefore, masking will be conducted at the data analyses level

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • not meeting inclusion criteria or unwillingness to participate

研究组 & 干预措施

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

干预措施: BASICS (Behavioral)

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).

干预措施: Online alcohol programming (Behavioral)

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

干预措施: BASICS (Behavioral)

结局指标

主要结局

Alcohol use

时间窗: Assessed over the course of 12 months

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.

Alcohol-related consequences

时间窗: Assessed over the course of 12 months

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

次要结局

  • Completion rates(One time assessment at end of program, after 1 session is completed 1 to 2 weeks post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Pedersen

Associate Professor of Psychiatry and Behavioral Sciences

University of Southern California

研究点 (2)

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