Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities

NCT ID: NCT02588703

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-04-30

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).

Conditions

Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy

9-session 2-hour group cognitive behavioral therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Coping Skills Treatment

Usual Care

9-session 2-hour group counseling

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Existing DUI program group counseling

Interventions

Cognitive Behavioral Therapy

Coping Skills Treatment

Intervention Type: BEHAVIORAL

Usual Care

Existing DUI program group counseling

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RAND

OTHER

Sponsor Role: lead

Responsible Party

Karen Osilla

Senior Behavioral Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen C Osilla, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

References

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.

Reference Type: DERIVED

PMID: 27036221 (View on PubMed)

Other Identifiers

R01MD007762

Identifier Type: NIH

Identifier Source: org_study_id

View Link