NCT02416713

Brief Summary

Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

April 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

April 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 28, 2019

Completed
Last Updated

February 28, 2019

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

April 7, 2015

Results QC Date

June 19, 2018

Last Update Submit

February 6, 2019

Conditions

Teen DriversMotor Vehicle Accident

Keywords

DrivingTeensTextingCellphoneDriveIDMotor vehicle accident

Outcome Measures

Primary Outcomes (1)

  • Change in Frequency of Cellphone Unlocks

    Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)

    6 weeks

Study Arms (4)

Education Only (Control)

PLACEBO COMPARATOR

The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving.

Other: Education Only

Opt-in Blocking

EXPERIMENTAL

Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion.

Device: Cellcontrol DriveID

Opt-out Blocking

EXPERIMENTAL

Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion.

Device: Cellcontrol DriveID

Opt-out Blocking with Notification

EXPERIMENTAL

Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian.

Device: Cellcontrol DriveID

Interventions

Cellcontrol DriveIDDEVICE

Technology that blocks incoming and outgoing calls and texts.

Also known as: DriveID
Opt-in BlockingOpt-out BlockingOpt-out Blocking with Notification
Education OnlyOTHER

No active intervention, educational materials will be provided

Also known as: Control
Education Only (Control)

Eligibility Criteria

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

You may qualify if:

  • High school student
  • or 17 at start of the study
  • Have a valid driver's license
  • Lives in parent's/guardian's home
  • Drives to school
  • Primarily drive one car
  • Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  • Parent/guardian is willing to assist with installation
  • Admit to texting while driving \>1 time in the last 30 days

You may not qualify if:

  • \. Already uses a smartphone app or hardware device to limit cellphone use while driving

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

Title
Dr. M. Kit Delgado
Organization
University of Pennsylvania
Mucio.Delgado@uphs.upenn.edu
215-746-8256

Study Officials

  • Catherine McDonald, PhD, RN

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 15, 2015

Study Start

April 13, 2016

Primary Completion

March 24, 2017

Study Completion

March 24, 2017

Last Updated

February 28, 2019

Results First Posted

February 28, 2019

Record last verified: 2018-07

Locations

US(2)