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Project MADD - NIH Underage DUI and Ride

NCT03506880 — Not applicable, Completed, 2352 participants, Penn State University

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

RegistryNCT03506880
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment2352 (Actual)
SponsorPenn State University (Other); collaborators: National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ConditionsUnderage Drinking, Driving Under the Influence, Drinking, Teen
InterventionsMADD Materials, Surgeon General Materials (Behavioral)
Datesstart 2017-11-17, primary completion 2022-04-30, completion 2022-04-30, first posted 2018-04-24, last updated 2023-06-29
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
MADD MaterialsExperimentalBehavioral: MADD MaterialsHandbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Surgeon General MaterialsExperimentalBehavioral: Surgeon General MaterialsInformation published by the Surgeon General about teens and drinking
ControlNo interventionTAU
  • MADD Materials (Behavioral): Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
  • Surgeon General Materials (Behavioral): Information published by the Surgeon General about teens and drinking

+Outcome measures

Primary outcomes

  • Typical Weekend Drinking (DDQ) [Baseline, 6 month follow-up, and 12 month follow-up]: 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.
  • Declining to Ride With Impaired Drivers [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.

Secondary outcomes

  • Willingness to Ride in a Car With an Impaired Driver [Baseline, 6 month follow-up, and 12 month follow-up]: 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.

+Eligibility

Sex: All, ages: 15 Years to 18 Years, accepts healthy volunteers

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

+Posted results

Participant flow

MilestoneMADD MaterialsSurgeon General MaterialsActive Control
Started393393390
T2 (30 -days post-baseline)331328342
T3 (6-months post-baseline)315318319
T4 (12-months post-baseline)296305305
Completed296305305
Not completed978885

Outcome results

  • Typical Weekend Drinking (DDQ) (Primary), Mean, units on a scale: MADD Materials 0.53 +/- 1.56; Surgeon General Materials 0.53 +/- 1.57; Active Control 0.38 +/- 1.23 (p >0.05)
  • Declining to Ride With Impaired Drivers (Primary), Mean, units on a scale: MADD Materials 0.61 +/- 1.56; Surgeon General Materials 0.56 +/- 1.38; Active Control 0.31 +/- 0.99 (p <0.01)
  • Willingness to Ride in a Car With an Impaired Driver (Secondary), Mean, units on a scale: MADD Materials 1.22 +/- 0.03; Surgeon General Materials 1.22 +/- 0.03; Active Control 1.22 +/- 0.03 (p >0.01)

Adverse events

Time frame: 1 year

ArmDeathsSerious adverse eventsOther adverse events
MADD Materials0/393 (0.0%)0/393 (0.0%)0/393 (0.0%)
Surgeon General Materials0/393 (0.0%)0/393 (0.0%)0/393 (0.0%)
Active Control0/390 (0.0%)0/390 (0.0%)0/390 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Penn State UniversityUniversity Park, PennsylvaniaUnited States

+Study documents

+Investigators

+Funding

NIH grants: R01AA025301

My Notes