Reducing Driving Offenses of Adolescent Drinkers (ROAD)
February 24, 2011 updated by: Rhode Island Hospital
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.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
786
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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.
|
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.
|
Two educational session on road safety and 16 hours of volunteering in a local not for profit community service.
Four hours education about road safety and 16 hours volunteering at a local not for profit community service
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recidivism for future criminal offenses
Time Frame: 12 months post intervention completion
|
12 months post intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Alcohol use
Time Frame: 12 months post intervention completion
|
12 months post intervention completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ted D Nirenberg, PhD, Rhode Island Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
April 1, 2012
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 24, 2009
First Posted (Estimate)
February 25, 2009
Study Record Updates
Last Update Posted (Estimate)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 24, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01AA15708-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.