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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00851058
Other study ID # 5R01AA15708-3
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received February 24, 2009
Last updated February 24, 2011
Start date May 2007
Est. completion date April 2012

Study information

Verified date February 2011
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 786
Est. completion date April 2012
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 20 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
Community Counseling
Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital
Prototypic community service
Two educational session on road safety and 16 hours of volunteering in a local not for profit community service.
Prototypic community service
Four hours education about road safety and 16 hours volunteering at a local not for profit community service

Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recidivism for future criminal offenses 12 months post intervention completion No
Secondary Alcohol use 12 months post intervention completion No
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