NCT03506880

Project MADD - NIH Underage DUI and Ride

Completed NA Results posted Last updated 29 June 2023

What this trial tests

NA trial testing MADD Materials in Underage Drinking in 2,352 participants. Completed in 30 April 2022.

Timeline

17 November 2017

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	Penn State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	2,352
Start date	17 November 2017
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

• MADD Materials
• Surgeon General Materials

Conditions studied

• Underage Drinking — all drugs for Underage Drinking →
• Driving Under the Influence — all drugs for Driving Under the Influence →
• Drinking, Teen — all drugs for Drinking, Teen →

Sponsor

Penn State University

Who can join

Adults 15 to 18, any sex, with Underage Drinking or Driving Under the Influence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Typical Weekend Drinking (DDQ) Primary · 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.

Group	Value	95% CI
MADD Materials	0.53	± 1.56
Surgeon General Materials	0.53	± 1.57
Active Control	0.38	± 1.23

Declining to Ride With Impaired Drivers Primary · 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.

Group	Value	95% CI
MADD Materials	0.61	± 1.56
Surgeon General Materials	0.56	± 1.38
Active Control	0.31	± 0.99

Willingness to Ride in a Car With an Impaired Driver Secondary · 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 wi

Group	Value	95% CI
MADD Materials	1.22	± 0.03
Surgeon General Materials	1.22	± 0.03
Active Control	1.22	± 0.03

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.