- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496129
An Interactive Text-Message Based Brief Intervention to Reduce Substance-Impaired Driving Among College Students
Evaluation of an Interactive Text-Message Based Brief Intervention to Reduce Substance-Impaired Driving Among College Students
Study Overview
Status
Conditions
Detailed Description
Rates of substance-impaired driving remain especially high among college students, and substance-related traffic accidents remain the leading cause of substance-related death among young adults. Prevention and intervention efforts, such as brief Interventions (BIs) have been shown to decrease substance use and related problems. BIs attempt to identify and correct faulty normative beliefs and highlight consequences of substance use (such as driving after substance use) and BIs typically consist of one or two individual therapeutic meetings delivered in motivational interviewing style and include personalized feedback (based on a series of questionnaires completed by the student prior to their BI session). The reason why BIs have not been deployed - despite their demonstrated efficacy - is that it is not economically feasible for universities to hire and train staff to deliver in-person BIs to all college substance users, and very few college students seek out substance prevention or treatment services available on campus or in the surrounding communities. Innovative ways of delivering BIs to this at-risk population in a manner that is both effective and economically feasible have to be developed. Text messaging represents a particularly advantageous way to provide BIs as they can be highly personalized to the individual, accessed at any time that suits the individual's needs, and allow for engagement and interaction between the interventionist and participant. Given the high prevalence and fatal consequences of substance-impaired driving, intervention approaches with the ability to reach a large number of students at a low cost are imperative for reducing this extremely risky behavior. Personalized feedback delivered without a one-on-one intervention may effectively reduce substance use and problems, despite the fact that web-based and feedback-only interventions consistently demonstrate smaller effect sizes than in-person interventions at long-term follow-ups, with effects often dissipating after the first follow-up.
The present study will enhance and extend intervention effects by including MI consistent interactive text messages to provide an interpersonal and interactive element. Research indicates that college students prefer text messages to telephone calls and emails and rate this medium positively. However, few published studies in alcohol literature have implemented text-messaging interventions and no published studies have examined the effects of a text-based substance impaired driving BI among students who report recent substance-impaired driving. A text-based BI focused specifically on decreasing alcohol-impaired driving (AI-driving) among college students has been developed and evaluated in a pilot trial. This study indicated that a brief, text-based AI-driving intervention resulted in significantly greater reductions in AI-driving at the 3-month follow-up, compared to an intervention providing alcohol information alone. This was the first controlled study to demonstrate that a text-based AI-driving intervention could decrease AI-driving outcomes over time. However, it is not clear from this study whether interactive text messages are a crucial part of the intervention because this study did not compare an AI-driving feedback only condition to the AI-driving feedback + interactive texts condition.
The proposed study will extend these promising pilot results by (a) expanding inclusion criteria to include drug-impaired and combination drug and alcohol-impaired drivers, (b) increasing power and generalizability by recruiting 150 college students indicating recent substance-impaired driving, (c) dismantling the pilot trial design by including a personalized feedback only condition, and (d) including a 6-month and 1-year follow-up to determine whether intervention effects persist over time.
The overarching goal is to reduce driving after drinking, drug use, and combined drug/alcohol use among college students.
We will conduct a 3-group trial with 150 college students (project 50% female and 20% minority) recruited from a large public university.
Group 1: substance information only Group 2: substance-impaired driving personalized feedback only Group 3: substance impaired driving personalized feedback and MI interactive text messages
Aim 1: Evaluate a text based substance-impaired driving intervention in a Randomized Clinical Trial.
Hypothesis 1: Groups 2 and 3 will report greater reductions in driving after substance use at 3-month follow-up compared to Group 1.
Aim 2: Determine whether interactive text-messages sustain intervention effects over time.
Hypothesis 2: Group 3 will report greater reductions in driving after substance use at 6-month and 12-month follow-up compared to Group 2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Bowling Green, Kentucky, United States, 42101
- Gary Ransdell Hall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older
- Currently enrolled (full or part-time) in college
- Ability to speak, read, and write in English
- Reports driving after drinking two or more drinks prior to driving at least three times in the past three months AND/OR reports driving after using marijuana or any other substance prior to driving at least three times in the past three months
- Reports having access to a motor vehicle, a valid driver's license, and plans to drive a vehicle in the next 3 months
- Reports access to a cell phone and willingness to read intervention material and exchange 3 texts post intervention with the study administrator
- Reports a valid email address
Exclusion Criteria:
- Currently in treatment for substance use or abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized Feedback
Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback.
Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).
|
Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback.
Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).
|
Experimental: Personalized feedback and text messages
Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above).
Participants will be asked to send a text message back to the study administrator after viewing the feedback document.
After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions.
|
Experimental: Personalized feedback and text messages Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions. |
Active Comparator: Information Only
Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message.
|
Active Comparator: Information Only Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of times driving after using substances
Time Frame: 3 months, 6 months, 1 year
|
Participants will be asked to report the number of times they have driven within two hours of drinking alcohol or using other substances.
|
3 months, 6 months, 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenni B Teeters, PhD, Western Kentucky University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-187
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Alcohol-Impaired Driving
-
Rush University Medical CenterCompletedImpairment | Driving | Intoxication | Alcohol Impaired DrivingUnited States
-
University of BernETH Zurich; University of St.GallenCompletedAlcohol Drinking | Impaired Driving | Drunk DrivingSwitzerland
-
University of BernETH Zurich; University of St.GallenCompletedAlcohol Drinking | Impaired Driving | Transportation Accidents | Drunk DrivingSwitzerland
-
University of PennsylvaniaProgressive Auto InsuranceCompletedDriving Impaired | Distracted DrivingUnited States
-
University of PennsylvaniaGeneral Motors (GM)CompletedDistracted Driving | Impaired Driving | Driving BehaviorsUnited States
-
University of PennsylvaniaCompletedAlcohol Drinking | Alcohol Intoxication | Driving Under the Influence | Driving Impaired | Drive | Alcohol Impairment | Behavior, DrinkingUnited States
-
University of LiegeCompleted
-
Rhode Island HospitalAlzheimer's AssociationUnknown
-
Finnish Institute for Health and WelfareEuropean Commission; Hospital District of Helsinki and UusimaaCompleted
-
Western Kentucky UniversityEnrolling by invitationDriving ImpairedUnited States
Clinical Trials on Personalized feedback
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedWeight | Food Choice | Nutrition IntakeUnited States
-
University of HoustonCompletedHeavy DrinkingUnited States
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis | Alcohol Consumption | GamblingUnited States
-
Seattle Children's HospitalUnknown
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of South CarolinaUniversity of Vermont; University of TennesseeCompleted
-
State University of New York at BuffaloCompleted