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
About this trial
This is an interventional treatment trial for Alcohol Abuse
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
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
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
Learn more about this trial
Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
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