Trial Outcomes & Findings for Project MADD - NIH Underage DUI and Ride (NCT NCT03506880)
NCT ID: NCT03506880
Last Updated: 2023-06-29
Results Overview
Typical weekend drinking was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985), which asked teens to indicate the number of drinks they consumed on a typical Friday and Saturday during the past 6 months. These two items were summed to create the number of typical weekend drinks. Higher scores indicate the teen consumed a higher number of drinks on a typical weekend.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2352 participants
Primary outcome timeframe
Baseline, 6 month follow-up, and 12 month follow-up
Results posted on
2023-06-29
Participant Flow
Parent-teen dyads were recruited from a nationally representative predetermined Web panel (KnowledgePanel, KP) maintained by the consumer company Ipsos. KP members were randomly selected through probability-based sampling of addresses from the U.S. Postal Services' Delivery Sequence File which covers approximately 97% of U.S. households. Only individuals who were sampled through these probability-based techniques were eligible to participate.
Participant milestones
| Measure |
MADD Materials
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Surgeon General Materials
Information published by the Surgeon General about teens and drinking
Surgeon General Materials: Information published by the Surgeon General about teens and drinking
|
Active Control
Received HPV vaccine info
|
|---|---|---|---|
|
Overall Study
STARTED
|
393
|
393
|
390
|
|
Overall Study
T2 (30 -Days Post-baseline)
|
331
|
328
|
342
|
|
Overall Study
T3 (6-months Post-baseline)
|
315
|
318
|
319
|
|
Overall Study
T4 (12-months Post-baseline)
|
296
|
305
|
305
|
|
Overall Study
COMPLETED
|
296
|
305
|
305
|
|
Overall Study
NOT COMPLETED
|
97
|
88
|
85
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project MADD - NIH Underage DUI and Ride
Baseline characteristics by cohort
| Measure |
MADD Materials
n=393 Participants
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Surgeon General Materials
n=393 Participants
Information published by the Surgeon General about teens and drinking
Surgeon General Materials: Information published by the Surgeon General about teens and drinking
|
Active Control
n=390 Participants
Received HPV vaccine info
|
Total
n=1176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Teen Participants · <=18 years
|
393 Participants
n=99 Participants
|
393 Participants
n=107 Participants
|
390 Participants
n=206 Participants
|
1176 Participants
n=7 Participants
|
|
Age, Categorical
Teen Participants · Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Teen Participants · >=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Parent Participants · <=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Parent Participants · Between 18 and 65 years
|
385 Participants
n=99 Participants
|
387 Participants
n=107 Participants
|
382 Participants
n=206 Participants
|
1154 Participants
n=7 Participants
|
|
Age, Categorical
Parent Participants · >=65 years
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Continuous
Teen Participants
|
16.29 years
STANDARD_DEVIATION 1.09 • n=99 Participants
|
16.37 years
STANDARD_DEVIATION 1.11 • n=107 Participants
|
16.33 years
STANDARD_DEVIATION 1.09 • n=206 Participants
|
16.33 years
STANDARD_DEVIATION 1.09 • n=7 Participants
|
|
Age, Continuous
Parent Participants
|
46.58 years
STANDARD_DEVIATION 7.44 • n=99 Participants
|
46.90 years
STANDARD_DEVIATION 7.76 • n=107 Participants
|
46.77 years
STANDARD_DEVIATION 7.65 • n=206 Participants
|
46.75 years
STANDARD_DEVIATION 7.61 • n=7 Participants
|
|
Sex: Female, Male
Teen Participants · Female
|
179 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
579 Participants
n=7 Participants
|
|
Sex: Female, Male
Teen Participants · Male
|
214 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
597 Participants
n=7 Participants
|
|
Sex: Female, Male
Parent Participants · Female
|
223 Participants
n=99 Participants
|
213 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
640 Participants
n=7 Participants
|
|
Sex: Female, Male
Parent Participants · Male
|
170 Participants
n=99 Participants
|
180 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
536 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Teen Participants · Hispanic or Latino
|
115 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
316 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Teen Participants · Not Hispanic or Latino
|
278 Participants
n=99 Participants
|
290 Participants
n=107 Participants
|
292 Participants
n=206 Participants
|
860 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Teen Participants · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Hispanic or Latino
|
106 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
293 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Not Hispanic or Latino
|
287 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
883 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Parent Participants · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · Asian
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · Black or African American
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · White
|
288 Participants
n=99 Participants
|
305 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
893 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · More than one race
|
31 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Teen Participants · Unknown or Not Reported
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · Asian
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · Black or African American
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · White
|
302 Participants
n=99 Participants
|
313 Participants
n=107 Participants
|
305 Participants
n=206 Participants
|
920 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · More than one race
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Parent Participants · Unknown or Not Reported
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Teen Typical Weekly Drinking (DDQ)
|
0.23 units on a scale
STANDARD_DEVIATION 0.97 • n=99 Participants
|
0.20 units on a scale
STANDARD_DEVIATION 0.85 • n=107 Participants
|
0.23 units on a scale
STANDARD_DEVIATION 1.01 • n=206 Participants
|
0.22 units on a scale
STANDARD_DEVIATION 0.94 • n=7 Participants
|
|
Teen Riding with Impaired Drivers Measures
Impaired driving
|
0.16 units on a scale
STANDARD_DEVIATION 0.87 • n=99 Participants
|
0.10 units on a scale
STANDARD_DEVIATION 0.68 • n=107 Participants
|
0.08 units on a scale
STANDARD_DEVIATION 0.55 • n=206 Participants
|
0.11 units on a scale
STANDARD_DEVIATION 0.71 • n=7 Participants
|
|
Teen Riding with Impaired Drivers Measures
Declining to ride with impaired driver
|
0.51 units on a scale
STANDARD_DEVIATION 1.33 • n=99 Participants
|
0.44 units on a scale
STANDARD_DEVIATION 1.32 • n=107 Participants
|
0.37 units on a scale
STANDARD_DEVIATION 1.17 • n=206 Participants
|
0.44 units on a scale
STANDARD_DEVIATION 1.28 • n=7 Participants
|
|
Teen Riding with Impaired Drivers Measures
Passenger in car with impaired driver
|
0.57 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 1.82 • n=107 Participants
|
0.46 units on a scale
STANDARD_DEVIATION 1.72 • n=206 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 1.85 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow-up, and 12 month follow-upPopulation: Participants included in analyses from T4 (12-month post-baseline assessment).
Typical weekend drinking was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985), which asked teens to indicate the number of drinks they consumed on a typical Friday and Saturday during the past 6 months. These two items were summed to create the number of typical weekend drinks. Higher scores indicate the teen consumed a higher number of drinks on a typical weekend.
Outcome measures
| Measure |
MADD Materials
n=296 Participants
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Surgeon General Materials
n=305 Participants
Information published by the Surgeon General about teens and drinking
Surgeon General Materials: Information published by the Surgeon General about teens and drinking
|
Active Control
n=305 Participants
Received HPV vaccine info
|
|---|---|---|---|
|
Typical Weekend Drinking (DDQ)
|
0.53 units on a scale
Standard Deviation 1.56
|
0.53 units on a scale
Standard Deviation 1.57
|
0.38 units on a scale
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: T4 (12-months post-baseline)Declining riding with impaired drivers was assessed with two items adapted from Hultgren et al (2018). Teens were asked to indicate the number of times they declined a ride from a driver that consumed alcohol and the number of times they declined a ride from a driver that consumed any drug other than alcohol (e.g., marijuana, opioids) in the past 6 months. Responses were summed to indicate the number of times they declined rides from impaired drivers in the past 6 months. Higher scores indicate the participant declined more rides from impaired drivers.
Outcome measures
| Measure |
MADD Materials
n=296 Participants
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Surgeon General Materials
n=305 Participants
Information published by the Surgeon General about teens and drinking
Surgeon General Materials: Information published by the Surgeon General about teens and drinking
|
Active Control
n=305 Participants
Received HPV vaccine info
|
|---|---|---|---|
|
Declining to Ride With Impaired Drivers
|
0.61 units on a scale
Standard Deviation 1.56
|
0.56 units on a scale
Standard Deviation 1.38
|
0.31 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline, 6 month follow-up, and 12 month follow-upPopulation: Participants included in analyses from T3 (6-months post-baseline). These analyses examine participants willingness to ride in a car with an impaired driver.
Willingness to ride in a car with an impaired driver was assessed with two items adapted from Hultgren et al. (2018). Teens responded using a 7-point scale that ranged from (0) Strongly disagree to (6) Strongly agree on their level of agreement to the following statements, "I am willing to be a passenger in a vehicle when the driver has consumed alcohol." and "I am willing to be a passenger in a vehicle when the driver has consumed any drug other than alcohol (e.g., marijuana, ecstasy, opioids).". Responses were averaged to create a mean score. Higher scores indicate the participant is more willing to be a passenger in a car with an impaired driver.
Outcome measures
| Measure |
MADD Materials
n=314 Participants
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Surgeon General Materials
n=316 Participants
Information published by the Surgeon General about teens and drinking
Surgeon General Materials: Information published by the Surgeon General about teens and drinking
|
Active Control
n=318 Participants
Received HPV vaccine info
|
|---|---|---|---|
|
Willingness to Ride in a Car With an Impaired Driver
|
1.22 units on a scale
Standard Error 0.03
|
1.22 units on a scale
Standard Error 0.03
|
1.22 units on a scale
Standard Error 0.03
|
Adverse Events
MADD Materials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgeon General Materials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
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