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Completed

NCT Number: NCT02247388

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Alcohol Screening

Behavioral

iPad based automated alcohol screening

Brief Negotiated Interview

Behavioral

iPad based automated brief negotiated interview (BNI)

Other names: BNI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos

Acronym: AB-CASI

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2014
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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