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Project MADD - NIH Underage DUI and Ride

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ClinicalTrials.gov Identifier: NCT03506880
Recruitment Status : Active, not recruiting
First Posted : April 24, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Robert Turrisi, Penn State University

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.

Condition or disease Intervention/treatment Phase
Underage Drinking Driving Under the Influence Drinking, Teen Behavioral: MADD Materials Behavioral: Surgeon General Materials Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1 group receives the MADD parent intervention; the second group receives active control parent materials from the Surgeon General; and the third group is TAU
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Examining an Intervention to Reduce Underage DUI and Riding With Impaired Drivers
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2019
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: MADD Materials
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Behavioral: MADD Materials
Active Comparator: Surgeon General Materials
Information published by the Surgeon General about teens and drinking
Behavioral: Surgeon General Materials
No Intervention: Control
TAU



Primary Outcome Measures :
  1. Reduce Risky Behaviors of Teens [ Time Frame: Baseline, 6 month follow-up, and 12 month follow-up ]
    Use surveys to see if the number of reported instances of teens exhibiting risky behaviors (ex. underage drinking, DUI, and riding with drunk drivers (RWDD)) changes over time


Secondary Outcome Measures :
  1. Examine Changes in Participant Mindsets [ Time Frame: Baseline, 6 month follow-up, and 12 month follow-up ]
    Use surveys to examine if the intervention influences risky behavioral tendencies in teens; 7-point scale (ranging from low agreement to high agreement) addressing teens' agreement with a statement (ex. their attitude, what they expect, what they perceive to be the 'norm', their reaction to parental communications)



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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506880


Locations
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United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Robert Turrisi, Ph.D. Penn State University
  Study Documents (Full-Text)

Documents provided by Robert Turrisi, Penn State University:

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Responsible Party: Robert Turrisi, Professor of Biobehavioral Health, Penn State University
ClinicalTrials.gov Identifier: NCT03506880     History of Changes
Other Study ID Numbers: 187458
R01AA025301 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Underage Drinking
Alcohol Drinking
Drinking Behavior