Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI) (AB-CASI)

April 21, 2022 updated by: Yale University

Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos

To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in the Emergency Department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research team will rigorously test the efficacy of AB-CASI, against a standard condition (SC) in a first-of-a-kind ED randomized controlled trial. Studying an urban adult (≥ 18 y/o) Latino ED population, the objectives are to demonstrate the superiority of AB-CASI compared to SC in: 1) reduction of alcohol consumption (Aims 1), 2) reduction of negative health behaviors and consequences (Aim 2), and 3) increasing 30-day treatment engagement (Aim 3). The investigators will also explore variation of the AB-CASI intervention on alcohol consumption, alcohol-related negative health behaviors and consequences, and 30-day treatment engagement by Latino subpopulations (Puerto-Rican, Mexican-American, Cuban-American, South/Central American) as well as other potential modifiers (age, birthplace, gender, preferred language, reason for ED visit, and smoking status). English and Spanish speaking Latino adults presenting to the Bridgeport Hospital ED will be screened using the study inclusion and exclusion criteria.

In March 2020, the primary and secondary outcomes were corrected to reflect the protocol as it was written initially. The citations section of this study registration also includes the citation for the published protocol manuscript.

Study Type

Interventional

Enrollment (Actual)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English and Spanish speaking adult
  • ≥ 18 y/o
  • Latino patients who present to the Bridgeport Hospital's ED
  • Drink over the NIAAA low-risk limits.

Exclusion Criteria:

  • Primary language other than English or Spanish
  • Current enrollment in an alcohol or substance abuse treatment program
  • Current ED visit for acute psychosis
  • Condition that precludes interview or AB-CASI use i.e., life threatening injury/illness
  • In police custody
  • Inability to provide two contact numbers for follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AB-CASI
Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention
Behavioral: Computerized Alcohol Screening
iPad based automated alcohol screening
Behavioral: Brief Negotiated Interview
iPad based automated brief negotiated interview (BNI)
Other Names:
  • BNI
No Intervention: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Reported Binge Drinking Episodes
Time Frame: 12 months

Self reported number of binge drinking episodes over the previous 28 days assessed using the 28 day timeline follow back at 12 months.

This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Weekly Drinks
Time Frame: 12 months post enrollment

Self reported mean number of weekly drinks as measured by a 28 day timeline follow back.

This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol. It was also moved to the secondary outcome measure section as was the original intent.
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: number of injuries
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: number of arrests
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment
Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school
Time Frame: 12 months post enrollment
Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school)
12 months post enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 Day Treatment Engagement
Time Frame: 30 days post enrollment
Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up
30 days post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Federico Vaca, MD, MPH, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1211011052
  • R01AA022083-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Dependence

Clinical Trials on Computerized Alcohol Screening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe