ROAD: Reducing Driving Offenses of Adolescent Drinkers

Sponsor

Rhode Island Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00851058

Collaborator

(none)

786

Enrollment

Location

Arms

Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effectiveness of four group session of motivational counseling plus six hours of direct observations of the emergency department trauma services in comparison to four group session and six hours of community volunteering and also in comparison to four hours of education and 16 hours of community volunteering in reducing alcohol use and high risk driving behaviors and offenses among court referred 16-20 year old drivers.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Consumption	Behavioral: Brief group counseling Behavioral: Community Counseling Behavioral: Prototypic community service Behavioral: Prototypic community service	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

786 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized Control Trial of the Effectiveness of of Group Motivational Counseling and an Emergency Department Experience in Reducing Risky Alcohol Use and Driving Behaviors.

Study Start Date :

May 1, 2007

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Counseling Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital	Behavioral: Brief group counseling Four group counseling sessions and six hours of direct observations of the emergency and trauma services in a busy urban hospital.
Active Comparator: Community Counseling Four session of group counseling and six hours of volunteering in a local not for profit community agency.	Behavioral: Community Counseling Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital
Placebo Comparator: Prototypic Community Service Four hours of education about road safety and 16 hours volunteering at a local not for profit community service.	Behavioral: Prototypic community service Two educational session on road safety and 16 hours of volunteering in a local not for profit community service. Behavioral: Prototypic community service Four hours education about road safety and 16 hours volunteering at a local not for profit community service

Arm

Intervention/Treatment

Experimental: Counseling

Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital

Behavioral: Brief group counseling

Four group counseling sessions and six hours of direct observations of the emergency and trauma services in a busy urban hospital.

Active Comparator: Community Counseling

Four session of group counseling and six hours of volunteering in a local not for profit community agency.

Behavioral: Community Counseling

Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital

Placebo Comparator: Prototypic Community Service

Four hours of education about road safety and 16 hours volunteering at a local not for profit community service.

Behavioral: Prototypic community service

Two educational session on road safety and 16 hours of volunteering in a local not for profit community service.

Behavioral: Prototypic community service

Four hours education about road safety and 16 hours volunteering at a local not for profit community service

Outcome Measures

Primary Outcome Measures

Recidivism for future criminal offenses [12 months post intervention completion]

Secondary Outcome Measures

Alcohol use [12 months post intervention completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Age 16-20 years:

Court referral for driving conviction and/or possession of alcohol
Offense committed in Rhode Island
Can speak English

Exclusion Criteria:

Age over 20 years
Not English speaking
Not referred by courts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rhode Island Hospital	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

Rhode Island Hospital

Investigators

Principal Investigator: Ted D Nirenberg, PhD, Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00851058

Other Study ID Numbers:

5R01AA15708-3

First Posted:

Feb 25, 2009

Last Update Posted:

Feb 25, 2011

Last Verified:

Feb 1, 2011

Keywords provided by , ,

Behavioral research

Motivational counseling

Group Counseling

Motivational Interviewing

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Feb 25, 2011