NCT02319317

Brief Summary

The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 4, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

December 8, 2014

Results QC Date

September 5, 2017

Last Update Submit

October 3, 2017

Conditions

AdolescentAccidents, TrafficAttentionMotor Vehicles

Outcome Measures

Primary Outcomes (1)

  • Retention of Participants

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

    Baseline (Study Visit 1) through Study Visit 4 (around 6 months).

Secondary Outcomes (5)

  • Proportion of Participants Randomized

    Baseline (Study Visit 1)

  • Adherence

    Baseline (Study Visit 1) through completion of the intervention.

  • Simulated Driving Performance

    Baseline (Study Visit 1) through Study Visit 3

  • Self-report Driving Behaviors

    Baseline (Study Visit 1) through Study Visit 4 (around 6 months).

  • Driving Citations and Crashes

    Baseline (Study Visit 1) through Study Visit 4 (around 6 months).

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: Control group general health promotion

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.

Risky driving prevention
Control group general health promotionBEHAVIORAL

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).
  • Pennsylvania driver's license for 90 days or less at time of assent
  • Personal email address and computer and internet access
  • Willingness to travel to CHOP twice to complete simulated assessment
  • Ability to read and write English

You may not qualify if:

  • Self-reported of claustrophobia, migraine headaches, or motion sickness
  • Self-reported current pregnancy
  • Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months

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

Related Publications (1)

  • McDonald CC, Sommers MS, Fargo JD, Seacrist T, Power T. Simulated Driving Performance, Self-Reported Driving Behaviors, and Mental Health Symptoms in Adolescent Novice Drivers. Nurs Res. 2018 May/Jun;67(3):202-211. doi: 10.1097/NNR.0000000000000270.

    PMID: 29701615DERIVED

Results Point of Contact

Title
Catherine McDonald. PhD, RN
Organization
University of Pennsylvania
mcdonalc@nursing.upenn.edu
2157468355

Study Officials

  • Catherine C McDonald, PhD, RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 8, 2014

First Posted

December 18, 2014

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

July 31, 2017

Last Updated

November 6, 2017

Results First Posted

October 4, 2017

Record last verified: 2017-10

Locations

US(2)