InjuriesPhase 1/2RYDDNCT00852085
Reducing Youthful Dangerous Driving
A Phase 1/2 study testing Enhanced community service and Group MI in people with Injuries, run by Rhode Island Hospital.
Trial summary
To examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors Read more about this study
- Who is it for?
- Ages 16 to 20 years
- Conditions the study is for
- Injuries
- What is being tested?
- Enhanced community service and Group MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Jun 2009
- 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
- Age 16-20 years
- Court referred for driving offense
- Speak English
Who cannot join
- Age over 20 years
- Not court referred
- Not English speaking
About this study
To examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors
- Conditions
- Injuries
- Being tested
- Enhanced community service, Group MI
- Keywords
- Counseling, Crime, Adolescent
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced community serviceBehavioural
Two educational sessions and volunteering at a local community service site
Group MIBehavioural
Four group counseling sessions and two directed observational visits to an emergency department
| Study group | Role | What they receive |
|---|---|---|
| Group MI | Experimental | Four group counseling sessions and a directed observational visit to the emergency department of a busy urban hospital Receives: Behavioral: Group MI |
| Enhanced community service | Active comparator | Not described Receives: Behavioral: Enhanced community service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of traffic offenses
Measured: 12 months post intervention completion
Secondary outcomes (1)
Self-reported high risk driving behaviors
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 posted26 Feb 2009 (estimated)
- Study startOct 2005
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies 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
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852085
- Sponsor's protocol ID
- 5R49CE000544-03
- Acronym
- RYDD
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Youthful Dangerous Driving
- ClinicalTrials.gov ID
- NCT00852085
- Acronym / sponsor ID
- RYDD / 5R49CE000544-03
- Conditions
- Injuries
- Keywords
- Counseling, Crime, Adolescent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 26 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 examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MI | Experimental | Behavioral: Group MIFour group counseling sessions and a directed observational visit to the emergency department of a busy urban hospital |
| Enhanced community service | Active comparator | Behavioral: Enhanced community service |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-20 years
- Court referred for driving offense
- Speak English
Key exclusion criteria (3 listed)
- Age over 20 years
- Not court referred
- Not English speaking
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 |
|---|---|---|
| Enhanced community serviceTwo educational sessions and volunteering at a local community service site | Behavioural | Enhanced community service |
| Group MIFour group counseling sessions and two directed observational visits to an emergency department | Behavioural | Group MI |
Primary outcome
Rates of traffic offenses
Time frame: 12 months post intervention completion
1 secondary outcome
Self-reported high risk driving behaviors
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 26 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Enhanced community service and Group MI in people with Injuries, run by Rhode Island Hospital.
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 3 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 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Rates of traffic 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 26 Feb 2009.