Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving

Driving Impaired Clinical Trial

Official title:

Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving Among Emerging Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05537116
• Other study ID #: 22-012
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2023
• Source: Western Kentucky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Substance-Impaired Driving among emerging adults 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 this age group, but are not often implemented - despite their demonstrated efficacy - because it is not economically feasible to deliver in-person BIs to all emerging adult substance users. The present study will be the first to examine whether a text-messaging-based cannabis-impaired driving BI significantly decreases cannabis-impaired driving among emerging adult cannabis users compared to an informational control. Participants will be 240 emerging adults who endorse driving after cannabis use (or combined alcohol and cannabis use) at least three times 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 and 6 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 cannabis-impaired driving intervention in a randomized clinical trial, and 2) to determine whether the use of interactive text-messages sustains intervention effects over time.

Description:

Rates of substance-impaired driving remain especially high among emerging adults, and substance-related traffic accidents remain the leading cause of substance-related death in this age group. Although rates of alcohol-impaired driving (AI-driving) among emerging adults have begun to decrease, rates of driving after cannabis use (DACU) continue to rise. In addition, many emerging adults report simultaneous use of alcohol and cannabis, a behavior that has been shown to increase the odds of substance-impaired driving and results in substantially greater fatal crash risk. Brief Interventions (BIs) have been shown to decrease substance use and related problems.6 BIs attempt to identify and correct faulty normative beliefs and highlight personal consequences of substance use (such as driving after substance use). BIs typically consist of one or two individual therapeutic meetings delivered in motivational interviewing (MI) style and include personalized feedback (based on a series of questionnaires completed by the participant prior to their BI session). One reason why BIs have not been widely implemented- despite their demonstrated efficacy - is that it is not economically feasible for universities and community agencies to hire and train staff to deliver in-person BIs to all substance users, and very few emerging adults 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, need to be developed. Text messaging represents a particularly advantageous way to provide BIs as they can be highly personalized to the individual and allows for engagement and interaction between the interventionist and participant. Research indicates that emerging adults prefer text messages to telephone calls and emails and rate this medium positively. Given the high prevalence and fatal consequences of substance-impaired driving, highly accessible intervention approaches are imperative for reducing this extremely risky behavior.

In the past few years, a number of interventions using text-messaging to target substance use and problems have been developed and evaluated with reviews and meta-analyses suggesting that the majority of these interventions result in improved outcomes and warrant further large scale studies. Most of these interventions target overall substance use and problems and do not focus on specific risk behaviors, such as substance-impaired driving. We have developed and evaluated a mobile-based BI focused specifically on decreasing AI-driving among college students in a pilot trial. This study indicated that a brief, mobile-based AI-driving intervention including MI text messaging resulted in significantly greater reductions in AI-driving at the 3-month follow-up, compared to alcohol information alone. We modified the intervention to focus on driving after cannabis use and found that the intervention resulted in significantly greater increases in perceived dangerousness of DACU and significantly greater decreases in DACU compared to to an informational control condition. Importantly, several recent studies have demonstrated greater effectiveness of interventions that include personal contact vs. those that are fully automated. The present study provides an important bridge between in-person therapist delivered interventions and fully automated interventions by utilizing interactive text messaging with participants in order to enhance retention of intervention elements and provide tailored, individualized interaction. It is imperative to directly test whether the use of interactive text-messages decreases substance-impaired driving significantly more than personalized feedback alone.

The proposed study will extend promising pilot results by: (a) increasing power by recruiting 240 emerging adults reporting recent driving after cannabis use (DACU), (b) increasing generalizability by recruiting non-college emerging adults to make up at least half of the sample, (c) including a 6-month follow-up to determine whether intervention effects persist over time, (d) examining mediators of intervention outcomes (e.g., changes in cannabis-related cognitions), and (e) providing additional intervention content focused on decreasing driving after combined use of alcohol and cannabis. The overarching goal is to use mobile technology to reduce driving after substance use among emerging adult cannabis users.

We will conduct a 3-group trial with 240 emerging adults (ages 18-25; project 50% female; 20% minority) recruited from a community in the Southeastern United States.

Group 1: substance impaired driving personalized feedback Group 2: substance impaired driving personalized feedback and Motivational Interviewing (MI) interactive text messages Group 3: substance use information (control) Aim 1: Evaluate a text based substance-impaired driving intervention in a Randomized Clinical Trial.

Hypothesis 1: Group 2 will report greater reductions in driving after cannabis use and driving after simultaneous alcohol and cannabis use 3- and 6-months post-intervention.

Aim 2: Evaluate mechanisms of intervention response. Hypothesis 1: Cognitive factors (e.g., changes in perceptions of dangerousness and consequences, peer norms, cannabis expectancies) will mediate intervention outcomes.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Age 18 or older

• Ability to speak, read, and write in English

• Reports driving after using cannabis 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 6 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

Related Conditions & MeSH terms

• Driving Impaired

Intervention

Behavioral:
• 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).
• 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 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.

Locations

Country	Name	City	State
United States	Kelly Thompson Hall	Bowling Green	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Western Kentucky University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peer norms	Perceived peer norms will be assessed by asking participants to indicate "How much do you think a typical college student approves of driving a car after using marijuana?" on a 7-point Likert scale from 1 (strongly disapprove) to 7 (strongly approve).	3 and 6 months post-intervention
Other	Perceived dangerousness	Perceived dangerousness related to DACU will be assessed by asking participants to indicate, "How dangerous do you believe it is to drive after marijuana use?" on a 4-point Likert scale from 1 (Not at all dangerous) to 4 (Very dangerous).	3 and 6 months post-intervention
Other	Perceived consequences	Perceived consequences related to DACU will be assessed by asking participants to indicate their perceived likelihood of being stopped by the police, being drug tested, being arrested, and having an accident on a 4-point Likert scale from 1 (Not very likely) to 4 (very likely).	3 and 6 months post-intervention
Other	Cannabis Expectancies	Cannabis expectancies will be assessed using the Marijuana Expectancies Questionnaire-Brief. Scores range from 6-30 with higher scores representing higher levels of positive and negative expectancies	3 and 6 months post-intervention
Primary	Driving after cannabis use	Number of times driving after cannabis use in the past 3 months	3 and 6 months post-intervention
Secondary	Driving after combined alcohol and cannabis use	Number of times driving after combined use of alcohol and cannabis in the past 3 months	3 and 6 months post-intervention