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Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Usual Care
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • meets criteria for at-risk drinking,
  • 21 years+,
  • English speaking,
  • current client in 3-month DUI program

Exclusion Criteria:

  • under 21,
  • does not speak English,
  • does not meet criteria for at-risk drinking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive Behavioral Therapy

    Usual Care

    Arm Description

    9-session 2-hour group cognitive behavioral therapy

    9-session 2-hour group counseling

    Outcomes

    Primary Outcome Measures

    heavy drinking (Survey)
    frequency of 5 drinks per day for men and 4 drinks per day for women

    Secondary Outcome Measures

    DUI Behaviors and Attitudes (Survey)

    Full Information

    First Posted
    August 17, 2015
    Last Updated
    April 8, 2020
    Sponsor
    RAND
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02588703
    Brief Title
    Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
    Official Title
    Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    April 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    RAND

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI programs for individuals with a first-time offense. Investigators will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will also be collected using administrative data two years post-treatment.
    Detailed Description
    Enormous unmet needs for alcohol treatment exist among individuals convicted of driving under the influence (DUI) since up to 43% recidivate and 67% meet criteria for alcohol dependence. Investigators will test whether delivering a cognitive behavioral treatment (CBT) for alcohol use disorders (AUDs) as part of a mandated DUI program improves health outcomes, and reduces alcohol use, alcohol-related problems and injuries, and DUI recidivism compared to usual care. The study has the potential to promote the public welfare by providing treatment to individuals with a DUI conviction, while focusing on Latinos, who are disproportionately less likely to access treatment and more likely to be arrested for a DUI, to have higher rates of recidivism, and to die in alcohol-related crashes than their white counterparts. The study is innovative because it would be the first to address effectiveness of treatment for AUDs embedded within a DUI program. Investigators will conduct a randomized trial of a 9-session group-based CBT (n=150) as compared to group-based usual care (UC; n=150) immediately after and 6 months after the end of treatment. Short-term outcomes include alcohol use (rates of heavy drinking, percent days abstinent), alcohol use-related self-efficacy, and intent to drink and drive. Investigators will also examine whether race/ethnicity, gender, acculturation, and alcohol situational norms predict our primary treatment outcomes (rates of heavy drinking, percent days abstinent) and DUI recidivism (alcohol-related violations).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Abuse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    351 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Behavioral Therapy
    Arm Type
    Experimental
    Arm Description
    9-session 2-hour group cognitive behavioral therapy
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    9-session 2-hour group counseling
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy
    Other Intervention Name(s)
    CBT
    Intervention Description
    Coping Skills Treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    Existing DUI program group counseling
    Primary Outcome Measure Information:
    Title
    heavy drinking (Survey)
    Description
    frequency of 5 drinks per day for men and 4 drinks per day for women
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    DUI Behaviors and Attitudes (Survey)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: meets criteria for at-risk drinking, 21 years+, English speaking, current client in 3-month DUI program Exclusion Criteria: under 21, does not speak English, does not meet criteria for at-risk drinking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen C Osilla, PhD
    Organizational Affiliation
    RAND
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27036221
    Citation
    Chan Osilla K, Watkins KE, Kulesza M, Florez K, Lara-Greenberg M, Miles JN. Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense. Addict Sci Clin Pract. 2016 Mar 31;11(1):7. doi: 10.1186/s13722-016-0053-x.
    Results Reference
    derived

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    Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities

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