Trial Outcomes & Findings for An Interactive Text-Message Based Brief Intervention to Reduce Substance-Impaired Driving Among College Students (NCT NCT03496129)
NCT ID: NCT03496129
Last Updated: 2025-08-11
Results Overview
Participants will be asked to report the number of times they have driven within two hours of drinking alcohol or using other substances.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
3 months
Results posted on
2025-08-11
Participant Flow
Participants were recruited via flyers around campus, the Sona system, and a mass email sent out to all students.
Eight participants screened eligible and were randomized after completing their baseline survey per the study protocol. However, they were then deemed ineligible after reviewing their answers on the baseline survey. These participants were then taken out of the trial and not included in any data analyses.
Participant milestones
| Measure |
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: 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.
Personalized feedback and text messages: 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 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.
Information Only: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
40
|
35
|
|
Overall Study
COMPLETED
|
28
|
38
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
Baseline characteristics by cohort
| Measure |
Personalized Feedback
n=28 Participants
Received personalized feedback intervention.
|
Personalized Feedback and Text Messages
n=38 Participants
Received personalize feedback and interactive text messages.
|
Information
n=31 Participants
Received generic information about substance use and driving.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
18 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Non-binary
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
1 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
3 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
1 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
4 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
3 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
4 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
7 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
27 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
26 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
78 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
2 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
4 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
3 Participants
n=107 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
0 Participants
n=206 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
3 Participants
n=7 Participants • 105 participants were randomized but only 97 completed all required study procedures and were included in data analyses.
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 monthsParticipants will be asked to report the number of times they have driven within two hours of drinking alcohol or using other substances.
Outcome measures
| Measure |
Personalized Feedback
n=28 Participants
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: 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
n=38 Participants
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.
Personalized feedback and text messages: 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 Only
n=31 Participants
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.
Information Only: 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.
|
|---|---|---|---|
|
Change in Number of Times Driving After Using Substances
|
22.43 Driving Events
Standard Deviation 21.39
|
26.50 Driving Events
Standard Deviation 26.55
|
26.00 Driving Events
Standard Deviation 25.46
|
Adverse Events
Personalized Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Feedback and Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place