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Reducing Driving Offenses of Adolescent Drinkers (ROAD)

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ClinicalTrials.gov Identifier: NCT00851058
Recruitment Status : Unknown
Verified February 2011 by Rhode Island Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2009
Last Update Posted : February 25, 2011
Sponsor:
Information provided by:
Rhode Island Hospital

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE May 2007
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Recidivism for future criminal offenses [ Time Frame: 12 months post intervention completion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00851058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Alcohol use [ Time Frame: 12 months post intervention completion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Driving Offenses of Adolescent Drinkers
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Alcohol Consumption
Intervention  ICMJE
  • 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.
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Counseling
    Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital
    Intervention: Behavioral: Brief group counseling
  • Active Comparator: Community Counseling
    Four session of group counseling and six hours of volunteering in a local not for profit community agency.
    Intervention: Behavioral: Community Counseling
  • Placebo Comparator: Prototypic Community Service
    Four hours of education about road safety and 16 hours volunteering at a local not for profit community service.
    Interventions:
    • Behavioral: Prototypic community service
    • Behavioral: Prototypic community service
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 24, 2009)
786
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851058
Other Study ID Numbers  ICMJE 5R01AA15708-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ted Nirenberg PhD, Rhode Island Hospital
Study Sponsor  ICMJE Rhode Island Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ted D Nirenberg, PhD Rhode Island Hospital
PRS Account Rhode Island Hospital
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP