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Project MADD - NIH Underage DUI and Ride

Primary Purpose

Underage Drinking, Driving Under the Influence, Drinking, Teen

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MADD Materials
Surgeon General Materials
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Underage Drinking

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

MADD Materials

Surgeon General Materials

Control

Arm Description

Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens

Information published by the Surgeon General about teens and drinking

TAU

Outcomes

Primary Outcome Measures

Typical Weekend Drinking (DDQ)
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
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 Outcome Measures

Willingness to Ride in a Car With an Impaired Driver
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.

Full Information

First Posted
March 30, 2018
Last Updated
June 9, 2023
Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03506880
Brief Title
Project MADD - NIH Underage DUI and Ride
Official Title
Examining an Intervention to Reduce Underage DUI and Riding With Impaired Drivers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underage Drinking, Driving Under the Influence, Drinking, Teen

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 group receives the MADD parent intervention; the second group receives parent materials from the Surgeon General; and the third group is TAU
Masking
Participant
Allocation
Randomized
Enrollment
2352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MADD Materials
Arm Type
Experimental
Arm Description
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Arm Title
Surgeon General Materials
Arm Type
Experimental
Arm Description
Information published by the Surgeon General about teens and drinking
Arm Title
Control
Arm Type
No Intervention
Arm Description
TAU
Intervention Type
Behavioral
Intervention Name(s)
MADD Materials
Intervention Description
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Intervention Type
Behavioral
Intervention Name(s)
Surgeon General Materials
Intervention Description
Information published by the Surgeon General about teens and drinking
Primary Outcome Measure Information:
Title
Typical Weekend Drinking (DDQ)
Description
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.
Time Frame
Baseline, 6 month follow-up, and 12 month follow-up
Title
Declining to Ride With Impaired Drivers
Description
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.
Time Frame
T4 (12-months post-baseline)
Secondary Outcome Measure Information:
Title
Willingness to Ride in a Car With an Impaired Driver
Description
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.
Time Frame
Baseline, 6 month follow-up, and 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Turrisi, Ph.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Project MADD - NIH Underage DUI and Ride

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