NCT01624597

Brief Summary

This randomized controlled trial will evaluate an intervention that provides parents with objective feedback about their teen's driving as well as strategies to improve communication with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have reduced driving errors and increased safety behaviors than dyads with no feedback; and, parent-teen dyads who receive instruction on communication techniques will have improved quality and quantity of communication about driving than dyads not learning these techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

June 18, 2012

Last Update Submit

August 30, 2018

Conditions

Keywords

Road traffic safety

Outcome Measures

Primary Outcomes (1)

  • Driving errors by newly licensed teen drivers

    An in-vehicle video system will be used to measure driving errors made by newly licensed teen drivers

    6 months after licensure

Secondary Outcomes (2)

  • Safety behaviors of newly licensed teen drivers

    6 months post-licensure

  • Parent communication

    6 months

Study Arms (3)

Usual Care

NO INTERVENTION

Participants will have a passive in-vehicle video device installed in their car to measure driving errors and safety behaviors.

In-vehicle video feedback

EXPERIMENTAL

Participants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors.

Behavioral: In-vehicle video feedbackBehavioral: Parent communication

In-vehicle video feedback, parent communication

EXPERIMENTAL

Participants will receive feedback from an in-vehicle video system. A light on the system will blink when a driving event has been recorded. Parents will receive a weekly report card of driving errors. Parents will participate in an intervention that provides input on teaching and communicating about driving skills and safety behaviors.

Behavioral: Parent communication

Interventions

An in-vehicle video system will record driving errors and safety behaviors. A light on the system will blink to let the participant know that a driving error has been recorded. Parents will receive a weekly report card.

In-vehicle video feedback

Parents will receive instruction in teaching and effective communication about driving skills and driving safety. The intervention includes driving goals for teen drivers and parent communication strategies.

In-vehicle video feedbackIn-vehicle video feedback, parent communication

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Teen will receive Intermediate Driver's license in three months
  • Teen has regular access to a car
  • Can provide proof of insurance
  • One legal guardian will also consent to participation

You may not qualify if:

  • Either parent or teen is not an English speaker
  • A sibling has already participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Officials

  • Corinne Peek-Asa, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR
  • Daniel McGehee, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

June 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations