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

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02247388
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
840
1
2
67
12.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computerized Alcohol Screening
  • Behavioral: Brief Negotiated Interview
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
840 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

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

    Standard Care

    Outcome Measures

    Primary Outcome Measures

    1. Self Reported Binge Drinking Episodes [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.

    Secondary Outcome Measures

    1. Mean Number of Weekly Drinks [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.

    2. Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin [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)

    3. Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver [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)

    4. Alcohol-Related Negative Health Behaviors and Consequences: number of injuries [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)

    5. Alcohol-Related Negative Health Behaviors and Consequences: number of arrests [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)

    6. Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school [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)

    7. Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school [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)

    Other Outcome Measures

    1. 30 Day Treatment Engagement [30 days post enrollment]

      Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bridgeport Hospital Bridgeport Connecticut United States 06610

    Sponsors and Collaborators

    • Yale University
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT02247388
    Other Study ID Numbers:
    • 1211011052
    • R01AA022083-01A1
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Yale University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2022