Skip to content

Project MADD - NIH Underage DUI and Ride

Examining an Intervention to Reduce Underage DUI and Riding With Impaired Drivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03506880
Enrollment
2352
Registered
2018-04-24
Start date
2017-11-17
Completion date
2022-04-30
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking, Teen, Driving Under the Influence, Underage Drinking

Brief summary

Project MADD was designed to attempt to curb the alarming trends related to drunk driving and to move the field forward by testing a brief parent-intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. The aim of this project is to provide an easy-to-implement and low-cost alternative parent-based intervention that can be widely disseminated to address this important public health problem.

Detailed description

Drunk driving is a major public health problem. The National Highway Traffic Safety Administration reported nearly 10,000 people died in alcohol-related crashes in the U.S. in 2014. The problem is further magnified when one considers that each year over 1.3 million drivers in the U.S. are arrested for alcohol-impaired driving. As alarming as these statistics are they pale by comparison to estimates indicating that they only represent 1% of the 121 million self-reported episodes of alcohol-impaired driving among U.S. drivers each year. The proposed research will attempt to curb these alarming trends and move the field forward by conducting a randomized controlled trial testing a brief parent intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. Prior brief parent-based interventions fro this lab have provided sufficient preliminary evidence of participation, communication, and efficacy for changing under-age drinking to warrant a large-scale comprehensive study. The study will use an extremely rigorous design that meets the Society for Prevention Research Criteria for Efficacy as described in Flay et al., a nationally representative sample assessed at 3-waves (baseline, 6 mo. and 12 mo.) to examine generalizability and sustained effects, and an oversampled Hispanic/Latino subgroup to examine the parent-intervention's potential to reduce a health disparity in an underserved population. The aims are as follows: Aim 1: Evaluate the efficacy of the parent intervention (short and long term); Aim 2: Examine mediators of the PBI that directly influence drinking, impaired driving, and riding with impaired driver behaviors; and Aim 3: Identify moderators to help inform future tailoring and improvement in intervention effectiveness. To the extent that the research is successful, it will provide an easy to implement and low cost alternative that can be widely disseminated to address this important public health problem.

Interventions

BEHAVIORALMADD Materials

Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens

BEHAVIORALSurgeon General Materials

Information published by the Surgeon General about teens and drinking

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

1 group receives the MADD parent intervention; the second group receives parent materials from the Surgeon General; and the third group is TAU

Eligibility

Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Parent and teen both consent (forming a dyad testing unit); They are part of GfK's KnowledgePanel pool of participants

Exclusion criteria

* Outside of the teen age range

Design outcomes

Primary

MeasureTime frameDescription
Typical Weekend Drinking (DDQ)Baseline, 6 month follow-up, and 12 month follow-upTypical 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.
Declining to Ride With Impaired DriversT4 (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.

Secondary

MeasureTime frameDescription
Willingness to Ride in a Car With an Impaired DriverBaseline, 6 month follow-up, and 12 month follow-upWillingness 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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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
393
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
393
Active Control
Received HPV vaccine info
390
Total1,176

Baseline characteristics

CharacteristicMADD MaterialsTotalActive ControlSurgeon General Materials
Age, Categorical
Parent Participants
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Parent Participants
>=65 years
8 Participants22 Participants8 Participants6 Participants
Age, Categorical
Parent Participants
Between 18 and 65 years
385 Participants1154 Participants382 Participants387 Participants
Age, Categorical
Teen Participants
<=18 years
393 Participants1176 Participants390 Participants393 Participants
Age, Categorical
Teen Participants
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Teen Participants
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous
Parent Participants
46.58 years
STANDARD_DEVIATION 7.44
46.75 years
STANDARD_DEVIATION 7.61
46.77 years
STANDARD_DEVIATION 7.65
46.90 years
STANDARD_DEVIATION 7.76
Age, Continuous
Teen Participants
16.29 years
STANDARD_DEVIATION 1.09
16.33 years
STANDARD_DEVIATION 1.09
16.33 years
STANDARD_DEVIATION 1.09
16.37 years
STANDARD_DEVIATION 1.11
Ethnicity (NIH/OMB)
Parent Participants
Hispanic or Latino
106 Participants293 Participants90 Participants97 Participants
Ethnicity (NIH/OMB)
Parent Participants
Not Hispanic or Latino
287 Participants883 Participants300 Participants296 Participants
Ethnicity (NIH/OMB)
Parent Participants
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Teen Participants
Hispanic or Latino
115 Participants316 Participants98 Participants103 Participants
Ethnicity (NIH/OMB)
Teen Participants
Not Hispanic or Latino
278 Participants860 Participants292 Participants290 Participants
Ethnicity (NIH/OMB)
Teen Participants
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent Participants
American Indian or Alaska Native
5 Participants14 Participants7 Participants2 Participants
Race (NIH/OMB)
Parent Participants
Asian
13 Participants34 Participants12 Participants9 Participants
Race (NIH/OMB)
Parent Participants
Black or African American
32 Participants102 Participants39 Participants31 Participants
Race (NIH/OMB)
Parent Participants
More than one race
19 Participants48 Participants11 Participants18 Participants
Race (NIH/OMB)
Parent Participants
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
Parent Participants
Unknown or Not Reported
21 Participants56 Participants15 Participants20 Participants
Race (NIH/OMB)
Parent Participants
White
302 Participants920 Participants305 Participants313 Participants
Race (NIH/OMB)
Teen Participants
American Indian or Alaska Native
6 Participants8 Participants2 Participants0 Participants
Race (NIH/OMB)
Teen Participants
Asian
15 Participants40 Participants13 Participants12 Participants
Race (NIH/OMB)
Teen Participants
Black or African American
32 Participants100 Participants33 Participants35 Participants
Race (NIH/OMB)
Teen Participants
More than one race
31 Participants84 Participants30 Participants23 Participants
Race (NIH/OMB)
Teen Participants
Native Hawaiian or Other Pacific Islander
1 Participants3 Participants1 Participants1 Participants
Race (NIH/OMB)
Teen Participants
Unknown or Not Reported
20 Participants48 Participants11 Participants17 Participants
Race (NIH/OMB)
Teen Participants
White
288 Participants893 Participants300 Participants305 Participants
Sex: Female, Male
Parent Participants
Female
223 Participants640 Participants204 Participants213 Participants
Sex: Female, Male
Parent Participants
Male
170 Participants536 Participants186 Participants180 Participants
Sex: Female, Male
Teen Participants
Female
179 Participants579 Participants203 Participants197 Participants
Sex: Female, Male
Teen Participants
Male
214 Participants597 Participants187 Participants196 Participants
Teen Riding with Impaired Drivers Measures
Declining to ride with impaired driver
0.51 units on a scale
STANDARD_DEVIATION 1.33
0.44 units on a scale
STANDARD_DEVIATION 1.28
0.37 units on a scale
STANDARD_DEVIATION 1.17
0.44 units on a scale
STANDARD_DEVIATION 1.32
Teen Riding with Impaired Drivers Measures
Impaired driving
0.16 units on a scale
STANDARD_DEVIATION 0.87
0.11 units on a scale
STANDARD_DEVIATION 0.71
0.08 units on a scale
STANDARD_DEVIATION 0.55
0.10 units on a scale
STANDARD_DEVIATION 0.68
Teen Riding with Impaired Drivers Measures
Passenger in car with impaired driver
0.57 units on a scale
STANDARD_DEVIATION 2
0.52 units on a scale
STANDARD_DEVIATION 1.85
0.46 units on a scale
STANDARD_DEVIATION 1.72
0.52 units on a scale
STANDARD_DEVIATION 1.82
Teen Typical Weekly Drinking (DDQ)0.23 units on a scale
STANDARD_DEVIATION 0.97
0.22 units on a scale
STANDARD_DEVIATION 0.94
0.23 units on a scale
STANDARD_DEVIATION 1.01
0.20 units on a scale
STANDARD_DEVIATION 0.85

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 3930 / 3930 / 390
other
Total, other adverse events
0 / 3930 / 3930 / 390
serious
Total, serious adverse events
0 / 3930 / 3930 / 390

Outcome results

Primary

Declining to Ride With Impaired Drivers

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.

Time frame: T4 (12-months post-baseline)

ArmMeasureValue (MEAN)Dispersion
MADD MaterialsDeclining to Ride With Impaired Drivers0.61 units on a scaleStandard Deviation 1.56
Surgeon General MaterialsDeclining to Ride With Impaired Drivers0.56 units on a scaleStandard Deviation 1.38
Active ControlDeclining to Ride With Impaired Drivers0.31 units on a scaleStandard Deviation 0.99
Comparison: It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.p-value: <0.01Tukey's Post-Hoc
Primary

Typical Weekend Drinking (DDQ)

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.

Time frame: Baseline, 6 month follow-up, and 12 month follow-up

Population: Participants included in analyses from T4 (12-month post-baseline assessment).

ArmMeasureValue (MEAN)Dispersion
MADD MaterialsTypical Weekend Drinking (DDQ)0.53 units on a scaleStandard Deviation 1.56
Surgeon General MaterialsTypical Weekend Drinking (DDQ)0.53 units on a scaleStandard Deviation 1.57
Active ControlTypical Weekend Drinking (DDQ)0.38 units on a scaleStandard Deviation 1.23
Comparison: It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.p-value: >0.05Tukey's Post-Hoc
Secondary

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.

Time frame: Baseline, 6 month follow-up, and 12 month follow-up

Population: Participants included in analyses from T3 (6-months post-baseline). These analyses examine participants willingness to ride in a car with an impaired driver.

ArmMeasureValue (MEAN)Dispersion
MADD MaterialsWillingness to Ride in a Car With an Impaired Driver1.22 units on a scaleStandard Error 0.03
Surgeon General MaterialsWillingness to Ride in a Car With an Impaired Driver1.22 units on a scaleStandard Error 0.03
Active ControlWillingness to Ride in a Car With an Impaired Driver1.22 units on a scaleStandard Error 0.03
Comparison: It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.p-value: >0.01Tukey's Post-Hoc

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026