Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05537116 |
Other study ID # |
22-012 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.