- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04959461
Preventing Impaired Driving Among Adolescents (webCHAT)
May 4, 2023 updated by: Karen Osilla, Stanford University
A Pilot Trial to Prevent Intoxicated and Impaired Driving Among Adolescents
The primary goal of this project is to evaluate the efficacy of webCHAT, a single-session web-intervention, on reducing impaired driving among adolescents receiving behind-the-wheel training at driver education programs.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Alcohol and marijuana (AM) are the most commonly used substances among adolescents in the U.S. The consequences of AM use are significantly higher relative to use of either substance alone.
This study builds on effective interventions that have demonstrated reductions in alcohol and/or marijuana use and reduced consequences one year later, and proposes to adapt one of those interventions, CHAT, to the web (web-CHAT).
The investigators will evaluate the efficacy of web-CHAT among 15.5-17-year-old adolescents (n=150) recruited when teen participants are attending behind-the-wheel training.
The study has the potential to promote public welfare by improving adolescent health outcomes and reducing risky driving behaviors that can have substantial monetary and social costs, as well as by providing unique insight into what mediates reduced risky driving attitudes behaviors among those in the intervention.
The study is innovative because it is for both youth who are at risk for substance use as well as those who are not, and it is delivered during a teachable moment when adolescents receive driver's education.
Finally, this study can provide unique insights about the efficacy of web-CHAT to reduce marijuana initiation, use, and risky driving attitudes in the context of a changing marijuana policy climate.
A 3-year study is proposed to test the feasibility of research procedures in a driver education setting and pilot the efficacy of web-CHAT.
The investigators will test whether web-CHAT reduces alcohol and/or marijuana initiation or use compared to teens in UC, at three and six-month follow-up.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Osilla, PhD
- Phone Number: (650) 723-4000
- Email: kosilla@stanford.edu
Study Contact Backup
- Name: Katherine E Nameth, BS
- Phone Number: 6505429699
- Email: knameth@stanford.edu
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Recruiting
- DriveSafe Driving School
-
Contact:
- Ben Baron
- Email: benb@BaronEd.com
-
-
Michigan
-
Dearborn, Michigan, United States, 48126
- Recruiting
- DriveSafe Driving School
-
Contact:
- Rachel Wilson, BS
- Email: RWilson@acg.aaa.com
-
-
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
15 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 15.5-17 year olds enrolled in driver education school
- Access to a computer or smartphone
- Within one month of taking their driver's licensing exam
Exclusion Criteria:
- Under 15.5 or over 17 years old
- Not enrolled in one of the participating schools
- Non-English speaking
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: webCHAT
Single session 20-40minute self-guided web program that discusses promotes healthy decision making around driving and discusses the risks of alcohol and cannabis-influenced driving.
|
A self-guided, single session web intervention that utilizes a motivational interviewing style to prevent impaired driving
|
Active Comparator: Usual Care
Existing driving school education
|
6 hours of driver education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol and/or Cannabis use (scale from Monitoring the Future survey)
Time Frame: Baseline through month 6
|
Number of days of alcohol, marijuana, and/or co-use (concurrent and simultaneous) in the past 30 days
|
Baseline through month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Driving under the influence behaviors (scale from Monitoring the Future survey)
Time Frame: Baseline through month 6
|
Number of times they drove a car, motorcycle or other vehicle after using marijuana, alcohol, and/or both in the past 30 days
|
Baseline through month 6
|
Passenger driving behavior behaviors (scale from Monitoring the Future survey)
Time Frame: Baseline through month 6
|
Number of times they were a passenger in a car or other vehicle with a driver who had beenin the past 30 days drinking alcohol and/or using marijuana
|
Baseline through month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Osilla, PhD, professor
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 (Actual)
January 1, 2022
Primary Completion (Anticipated)
May 30, 2024
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
June 16, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 13, 2021
Study Record Updates
Last Update Posted (Estimate)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61874
- R34AA027689 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Following the NIH Data Sharing Policy and Implementation Guidelines, we plan to make the dataset available for sharing at the time that the main project findings are accepted for publication.
That is, the raw data file and codebook, which will initially be used for internal study team purposes, will be available for public use after our main intervention effects paper is published; within one year of the final year of funding.
IPD Sharing Time Frame
After our main intervention effects paper is published; within one year of the final year of funding.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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