Alcohol ConsumptionPhase 1/2ROADNCT00851058
Reducing Driving Offenses of Adolescent Drinkers
A Phase 1/2 study testing Brief group counseling, Community Counseling and Prototypic community service in people with Alcohol Consumption, run by Rhode Island Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 20 years
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Brief group counseling, Community Counseling and Prototypic community service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 786 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Age over 20 years
- Not English speaking
- Not referred by courts
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
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.
- Conditions
- Alcohol Consumption
- Being tested
- Brief group counseling, Community Counseling, Prototypic community service
- Keywords
- Behavioral research, Motivational counseling, Group Counseling, Motivational Interviewing, Vicarious Learning, Risky alcohol use, Recidivism, Motor Vehicles, Crime
- Medical subject headings
- Alcohol Drinking, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief group counselingBehavioural
Four group counseling sessions and six hours of direct observations of the emergency and trauma services in a busy urban hospital.
Community CounselingBehavioural
Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital
Prototypic community serviceBehavioural
Two educational session on road safety and 16 hours of volunteering in a local not for profit community service.
Prototypic community serviceBehavioural
Four hours education about road safety and 16 hours volunteering at a local not for profit community service
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Four session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital Receives: Behavioral: Brief group counseling |
| Community Counseling | Active comparator | Four session of group counseling and six hours of volunteering in a local not for profit community agency. Receives: Behavioral: Community Counseling |
| Prototypic Community Service | Placebo comparator | Four hours of education about road safety and 16 hours volunteering at a local not for profit community service. Receives: Behavioral: Prototypic community service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism for future criminal offenses
Measured: 12 months post intervention completion
Secondary outcomes (1)
Alcohol use
Measured: 12 months post intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionMar 2010 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ted D Nirenberg, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851058
- Sponsor's protocol ID
- 5R01AA15708-3
- Other IDs
- 5R01AA015708
- Acronym
- ROAD
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2009
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00851058
- Acronym / sponsor ID
- ROAD / 5R01AA15708-3
- Conditions
- Alcohol Consumption
- Keywords
- Behavioral research, Motivational counseling, Group Counseling, Motivational Interviewing, Vicarious Learning, Risky alcohol use, Recidivism, Motor Vehicles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: Brief group counselingFour session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital |
| Community Counseling | Active comparator | Behavioral: Community CounselingFour session of group counseling and six hours of volunteering in a local not for profit community agency. |
| Prototypic Community Service | Placebo comparator | Behavioral: Prototypic community serviceFour hours of education about road safety and 16 hours volunteering at a local not for profit community service. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Age over 20 years
- Not English speaking
- Not referred by courts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief group counselingFour group counseling sessions and six hours of direct observations of the emergency and trauma services in a busy urban hospital. | Behavioural | Counseling |
| Community CounselingFour session of group counseling and six hours of guided observation of the emergency and trauma services at a busy urban hospital | Behavioural | Community Counseling |
| Prototypic community serviceTwo educational session on road safety and 16 hours of volunteering in a local not for profit community service. | Behavioural | Prototypic Community Service |
| Prototypic community serviceFour hours education about road safety and 16 hours volunteering at a local not for profit community service | Behavioural | Prototypic Community Service |
Primary outcome
Recidivism for future criminal offenses
Time frame: 12 months post intervention completion
1 secondary outcome
Alcohol use
Time frame: 12 months post intervention completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted D Nirenberg, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brief group counseling, Community Counseling and Prototypic community service in people with Alcohol Consumption, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recidivism for future criminal offenses (time frame: 12 months post intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2011.