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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

Tracking Information
First Submitted Date  ICMJE March 30, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date June 7, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project MADD - NIH Underage DUI and Ride
Official Title  ICMJE Examining an Intervention to Reduce Underage DUI and Riding With Impaired Drivers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Underage Drinking
  • Driving Under the Influence
  • Drinking, Teen
Intervention  ICMJE
  • Behavioral: MADD Materials
  • Behavioral: Surgeon General Materials
Study Arms  ICMJE
  • Experimental: MADD Materials
    Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
    Intervention: Behavioral: MADD Materials
  • Active Comparator: Surgeon General Materials
    Information published by the Surgeon General about teens and drinking
    Intervention: Behavioral: Surgeon General Materials
  • No Intervention: Control
    TAU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
2352
Original Actual Enrollment  ICMJE
 (submitted: April 13, 2018)
1167
Estimated Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03506880
Other Study ID Numbers  ICMJE 187458
R01AA025301 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert Turrisi, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Robert Turrisi, Ph.D. Penn State University
PRS Account Penn State University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP