Behavior and Driving Safety Study | NCT00575679

Studies
Behavior and Driving Safety Study

NCT00575679

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Jan 4, 2019Actual

Enrollment

864Actual

Phase

Not Applicable

Conditions

Alcoholic Intoxication

Interventions

Brief motivational interview

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCDIRB-200614967
OTS-AL0757	Other Identifier	UC Davis

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008Actual

Primary Completion Date

Feb 20, 2014Actual

Completion Date

Feb 20, 2014Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2019

Last Update Posted Date

Jan 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of California, DavisOTHER

Collaborators

Name	Class
Sacramento Police Department	UNKNOWN
California Office of Traffic Safety	OTHER_GOV
University of Michigan	OTHER
Robert Wood Johnson Foundation

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).

Detailed Description

Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

864Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Brief motivational interview	Behavioral: Brief motivational interview
2	No Intervention	No discussion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brief motivational interview	Behavioral	The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to repeat arrest for driving under the influence of alcohol		Up until one year after the conclusion of enrollment

Secondary Outcomes

Measure	Description	Time Frame
Alcohol Use Disorders Identification Test score		6 and 12 months
Time to alcohol-related injury hospitalization		Up until one year after the conclusion of enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Second or greater arrest for driving under the influence of alcohol
Arrest involved operation of a motor vehicle
At least 18 years of age
English-speaking

Exclusion Criteria:

Arrest involved injury to another person
Previous participation in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Garth H Utter, MD MSc	University of California, Davis	Principal Investigator
Leon J Owens, MD	University of California, Davis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sacramento County Main Jail		Sacramento	California	95814	United States

Condition Browse Module

MeSH Terms

ID	Term
D000435	Alcoholic Intoxication
D000066448	Driving Under the Influence

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided