- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506880
Project MADD - NIH Underage DUI and Ride
June 9, 2023 updated by: Robert Turrisi, Penn State University
Examining an Intervention to Reduce Underage DUI and Riding With Impaired Drivers
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2352
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Penn State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
TAU
|
|
|
Experimental: MADD Materials
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
|
|
Experimental: Surgeon General Materials
Information published by the Surgeon General about teens and drinking
|
Information published by the Surgeon General about teens and drinking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Typical Weekend Drinking (DDQ)
Time Frame: 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.
|
Baseline, 6 month follow-up, and 12 month follow-up
|
|
Declining to Ride With Impaired Drivers
Time Frame: 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.
|
T4 (12-months post-baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to Ride in a Car With an Impaired Driver
Time Frame: 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.
|
Baseline, 6 month follow-up, and 12 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Turrisi, Ph.D., Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2017
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
March 30, 2018
First Submitted That Met QC Criteria
April 13, 2018
First Posted (Actual)
April 24, 2018
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 187458
- R01AA025301 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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