NCT02923271

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 9, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

October 3, 2016

Results QC Date

June 18, 2019

Last Update Submit

August 12, 2019

Conditions

Keywords

DrivingTeensTextingCellphoneDriveIDMotor vehicle accident

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Cellphone Unlocks Per Hour of Drive Time

    Change in number of cellphone unlocks per hour of drive time between baseline and the end of the intervention period

    8 weeks

Secondary Outcomes (1)

  • Change in the Number of Minutes of Phone Use Per Hour of Driving

    8 weeks

Study Arms (2)

Teen-Parent Monitoring Group

EXPERIMENTAL

Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen-parent monitoring group involves will send email notifications to the teen when their parent unlocks their phone while driving and vice versa. Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.

Device: CellControl

Teen Only Monitoring Group

EXPERIMENTAL

Cellcontrol DriveID device will automatically turn on when the teen or parent begins driving and will be pre-set to block all calls and text messages when the car is in motion but participants will have the ability to override the blocking. The teen only group involves parental monitoring of the teen's cellphone use while driving only. The parent will receive an email notification when their teen unlocks their phone while driving. Both parents and teens will drive under the same restrictions, but only the parent is notified of teen cellphone use. Participants (parents and teens) will self-report information on their individual driving behaviors for the three weeks prior to study enrollment, including how often they report texting while driving and self-report cellphone use. At the end of the study participants will be asked to report feedback about the use the cellphone blocking technology and their perceptions for whether their safety improved using the technology.

Device: CellControl

Interventions

Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks during baseline measurement period. During the intervention period (5 weeks) cellphone use will be monitored and blocking of incoming calls and texts will be active.

Also known as: DriveID
Teen Only Monitoring GroupTeen-Parent Monitoring Group

Eligibility Criteria

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

You may qualify if:

  • Both parent and teen will be enrolled together as a pair
  • Teen:
  • Is a high school student (age 16 or 17 at start of the study)
  • Holds a valid driver's license
  • Lives in parent/guardian's home
  • Primarily drives one car
  • Drives an average of 4 or more trips per week
  • Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  • Admits to texting while driving at least once in the last month
  • Parent:
  • Is the parent of a teen driver
  • Drives an average of 4 or more trips per week
  • Primarily drives one car
  • Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
  • Admits to texting while driving at least once in the last month

You may not qualify if:

  • Parent and/or teen 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)

The 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

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 4, 2016

Study Start

December 7, 2016

Primary Completion

September 13, 2017

Study Completion

November 16, 2017

Last Updated

August 20, 2019

Results First Posted

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations