NCT02695888

Brief Summary

This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
Last Updated

October 18, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

February 25, 2016

Last Update Submit

October 17, 2018

Conditions

AdolescentAccidents, TrafficAttentionMotor Vehicles

Outcome Measures

Primary Outcomes (1)

  • Retention of participants

    Proportion of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.

    Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)

Secondary Outcomes (2)

  • In-vehicle cell phone use

    Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)

  • Self-reported driving behaviors

    Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)

Study Arms (2)

Risky driving prevention

EXPERIMENTAL

Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.

Behavioral: Risky Driving Prevention

Control group

EXPERIMENTAL

Web-based behavioral intervention for healthy lifestyles.

Behavioral: Teen Healthy Living

Interventions

Risky Driving PreventionBEHAVIORAL

The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.

Also known as: Web-based intervention to prevent risky driving
Risky driving prevention
Teen Healthy LivingBEHAVIORAL

The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.

Control group

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
  • Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  • PA driver's license for 90 days or less at time of teen assent
  • Personal email address and computer and internet access
  • Ability to read and write English
  • Primarily drives one vehicle with the ability to accommodate the DriveID device
  • Parental consent and teen assent

You may not qualify if:

  • Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
  • Unable to follow study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4217, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4217, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 1, 2016

Study Start

March 1, 2016

Primary Completion

December 29, 2016

Study Completion

December 29, 2016

Last Updated

October 18, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)