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Alcohol-Impaired DrivingNCT03496129

An Interactive Text-Message Based Brief Intervention to Reduce Substance-Impaired Driving Among College Students

A study testing Personalized feedback, Personalized feedback and text messages and Information Only in people with Alcohol-Impaired Driving, run by Western Kentucky University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Substance-Impaired Driving among college students remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among college students, but are not often implemented - despite their… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol-Impaired Driving
What is being tested?
Personalized feedback, Personalized feedback and text messages and Information Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
22 Sep 2018to 30 Apr 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Currently in treatment for substance use or abuse

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Gary Ransdell Hall

    Bowling Green, Kentucky, 42101

Other trials in United States

About this study

Official title: Evaluation of an Interactive Text-Message Based Brief Intervention to Reduce Substance-Impaired Driving Among College Students

Substance-Impaired Driving among college students remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among college students, but are not often implemented - despite their demonstrated efficacy - because it is not economically feasible for universities to hire and train staff to deliver in-person BIs to all college substance users. Very few college students seek out substance prevention or treatment services available on campus or in the surrounding community. Innovative ways of delivering BIs to this at-risk population in a manner that is both effective and economically feasible have to be developed. The present study will be the first to examine whether a text-messaging-based substance-impaired driving BI significantly decreases substance-impaired driving among colleges substance users compared to an informational control. Participants will be 150 college students who endorse driving after substance use (alcohol, drugs, and/or combined alcohol/drugs) at least twice in the past 3 months. After completing baseline measures, participants will be randomly assigned to receive either: a) substance use information, b) a substance-impaired driving personalized feedback intervention, or c) a substance-impaired driving personalized feedback intervention plus interactive text messages. Participants will complete outcome measures 3, 6, and 12 months post-intervention. Repeated measures mixed modeling analyses will be used to determine whether the intervention significantly reduces substance-impaired driving over time. The project has two specific aims: 1) to evaluate a text based substance-impaired driving intervention in a randomized clinical trial, and 2) to determine whether the use of interactive text-messages sustains intervention effects over time. This study is innovative because it utilizes cutting-edge technology to deliver the entire intervention, enabling the study to reach a large number of students in a short time period at a low cost. The study is significant because it will contribute substantially to the substance-impaired driving literature by identifying an intervention that can decrease substance-impaired driving among this high-risk population. Additionally, this study will add to the newly emerging technology-based intervention literature.

Read the 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.

Being tested
Personalized feedback, Personalized feedback and text messages, Information Only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized feedbackBehavioural

    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).

  • Personalized feedback and text messagesBehavioural

    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.

  • Information OnlyBehavioural

    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.

Study groups in NCT03496129
Study groupRoleWhat they receive
Personalized FeedbackExperimentalFollowing 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).
Receives: Behavioral: Personalized feedback
Personalized feedback and text messagesExperimentalFollowing 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.
Receives: Behavioral: Personalized feedback and text messages
Information OnlyActive comparatorStudents 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.
Receives: Behavioral: Information Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of Times Driving After Using Substances

    Participants will be asked to report the number of times they have driven within two hours of drinking alcohol or using other substances.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start22 Sep 2018
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496129
Sponsor's protocol ID
18-187
Status last verified
Aug 2025
First submitted
3 Apr 2018
Last updated
11 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Teeters JB, King SA, Hubbard SM. A mobile phone-based brief intervention with personalized feedback and interactive text messaging is associated with changes in driving after cannabis use cognitions in a proof-of-concept pilot trial. Exp Clin Psychopharmacol. 2021 Apr;29(2):203-209. doi: 10.1037/pha0000442.

    PubMed 34043401

Questions about this trial

What is this clinical trial studying?

A study testing Personalized feedback, Personalized feedback and text messages and Information Only in people with Alcohol-Impaired Driving, run by Western Kentucky University 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 11 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Number of Times Driving After Using Substances (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03496129, which also lists 1 linked publication.

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 11 Aug 2025.

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