Project MADD - NIH Underage DUI and Ride

NCT ID: NCT03506880

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2022-04-30

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.

Conditions

Underage Drinking; Driving Under the Influence; Drinking, Teen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MADD Materials

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

Group Type: EXPERIMENTAL

MADD Materials

Intervention Type: BEHAVIORAL

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

Surgeon General Materials

Information published by the Surgeon General about teens and drinking

Group Type: EXPERIMENTAL

Surgeon General Materials

Intervention Type: BEHAVIORAL

Information published by the Surgeon General about teens and drinking

Control

TAU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MADD Materials

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

Intervention Type: BEHAVIORAL

Surgeon General Materials

Information published by the Surgeon General about teens and drinking

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Robert Turrisi

Professor of Biobehavioral Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Turrisi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AA025301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

187458

Identifier Type: -

Identifier Source: org_study_id