Way to Safety: Cellphone Blocking Technology to Reduce Cellphone Use While Driving Among Teens
Phase: NA
Conditions: Teen Drivers, Motor Vehicle Accident
Sponsor: Children's Hospital of Philadelphia

 
 
 
Title: 
Way to Safety: Cellphone Blocking Technology to Reduce 
Cellphone Use While Driving Among Teens 
Short Title 
Way to Safety Cellphone Blocking 
eIRB Number: 
14-011234 
Protocol Date: 
6/6/2016 
Amendment 1 Date: 10/3/2014 
Amendment 3 Date:  
Amendment 2 Date: 
Amendment 4 Date: 
 
Sponsor 
TAPITMAT-CHIBE Pilot Grant Program - 
Perelman School of Medicine, University of Pennsylvania 
 
Study Principal Investigator 
M. Kit Delgado, MD, MS 
Department of Emergency Medicine 
934 Blockley Hall 
423 Guardian Drive 
Philadelphia, PA, 19104 
Phone 215-746-8256 
email: mucio.delgado@uphs.upenn.edu 
 
Site Principal Investigator 
Catherine C. McDonald, PhD, RN 
University of Pennsylvania School of Nursing 
Claire Fagin Hall 
418 Curie Blvd, Room 414 
Philadelphia, PA 19104 
The Children’s Hospital of Philadelphia 
The Center for Injury Research and Prevention 
3535 Market Street, Suite 1150 
Philadelphia, PA, 19104 
PENN Phone: 215-746-8355 
CHOP Phone: 267-427-1236 
Email: mcdonalc@nursing.upenn.edu 
 

 
 
 
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract .................................................................................................................................. v 
Figure 1: Study Diagram ...................................................................................................... vi 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INTERVENTION ........................................................................................ 1 
1.3 
FINDINGS FROM NON-CLINICAL AND CLINICAL STUDIES ..................................................................... 2 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 3 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 4 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 4 
3.1.1 
Screening Phase .............................................................................................................................. 4 
3.1.2 
Baseline Measurement Period (Weeks 1-2) .................................................................................... 5 
3.1.3 
Intervention Period (Weeks 3-8) ..................................................................................................... 5 
3.1.4 
Follow-up Period ............................................................................................................................ 5 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 5 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 6 
3.3.1 
Duration of Study Participation ...................................................................................................... 6 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 6 
3.4 
STUDY POPULATION ............................................................................................................................. 6 
3.4.1 
Inclusion Criteria ............................................................................................................................ 6 
3.4.2 
Exclusion Criteria ........................................................................................................................... 6 
4 
STUDY PROCEDURES ............................................................................................................................ 6 
4.1 
SCREENING PROCEDURE AND ONLINE CONSENT/ASSENT PROCESS ..................................................... 6 
4.2 
DEVICE INSTALLATION ......................................................................................................................... 7 
4.3 
STUDY TREATMENT PHASE .................................................................................................................. 7 
4.3.1 
Baseline Measurement .................................................................................................................... 8 
4.3.2 
Intervention ..................................................................................................................................... 8 
4.3.3 
Follow-up Phase ............................................................................................................................. 8 
4.3.4 
Debriefing ....................................................................................................................................... 8 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 9 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................. 9 
5.1 
CONFIRMATION OF ELIGIBILITY ........................................................................................................... 9 
5.2 
INTAKE SURVEY ................................................................................................................................... 9 
5.3 
CELLCONTROL DATA ........................................................................................................................... 9 
5.4 
TEEN END OF STUDY SURVEY ............................................................................................................ 10 
5.5 
SAFETY EVALUATION ......................................................................................................................... 10 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 11 
6.1 
PRIMARY ENDPOINT ..................................................................... ERROR! BOOKMARK NOT DEFINED. 
6.2 
SECONDARY ENDPOINTS .............................................................. ERROR! BOOKMARK NOT DEFINED. 
6.3 
STATISTICAL METHODS ................................................................ ERROR! BOOKMARK NOT DEFINED. 
6.3.1 
Baseline Data .................................................................................. Error! Bookmark not defined. 
6.3.2 
Efficacy Analysis ............................................................................. Error! Bookmark not defined. 

 
 
 
 
 
 
 
 
 
 
iii
7 
STUDY INTERVENTION ...................................................................................................................... 13 
7.1 
DESCRIPTION ...................................................................................................................................... 13 
7.1.1 
Control Group ............................................................................................................................... 13 
7.1.2 
Active Group ................................................................................................................................. 13 
7.1.3 
Adjustment Group ......................................................................................................................... 13 
7.1.4 
No Adjustment Group .................................................................................................................... 13 
8 
SAFETY MANAGEMENT ..................................................................................................................... 13 
8.1 
ADVERSE EVENT REPORTING ............................................................................................................. 13 
9 
STUDY ADMINISTRATION ................................................................................................................. 14 
9.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 14 
9.1.1 
Randomization............................................................................................................................... 14 
9.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
9.2.1 
Way To Health............................................................................................................................... 14 
9.2.2 
Cellcontrol .................................................................................................................................... 15 
9.3 
CONFIDENTIALITY .............................................................................................................................. 15 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS .................................................................................. 15 
9.4.1 
Data and Safety Monitoring Plan ................................................................................................. 15 
9.4.2 
Risk Assessment ............................................................................................................................. 15 
9.4.3 
Potential Benefits of Study Participation ...................................................................................... 16 
9.4.4 
Risk-Benefit Assessment ................................................................................................................ 16 
9.5 
RECRUITMENT STRATEGY .................................................................................................................. 16 
9.6 
INFORMED CONSENT/ASSENT ............................................................................................................ 18 
9.6.1 
Waiver of Documentation of Consent/Assent .................................. Error! Bookmark not defined. 
9.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 18 
9.7.1 
Payment to parent for time and inconvenience (i.e. compensation) .............................................. 18 
9.7.2 
Payment to teen for time, effort and inconvenience (i.e. compensation) ....... Error! Bookmark not 
defined. 
9.7.3 
Gifts ............................................................................................................................................... 19 
10 
PUBLICATION ........................................................................................................................................ 19 
11 
REFERENCES ......................................................................................................................................... 19 
 

 
 
 
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
CHOP 
SAE 
UPenn/Penn 
 
Adverse Event 
Children’s Hospital of Philadelphia 
Serious Adverse Event 
University of Pennsylvania 
PMACS 
 
Penn Medicine Academic Computing Services 
SQL 
 
Structured Query Language 
PHP 
 
Hypertext Preprocessor 
SSL 
 
Secure Sockets Layer 
HTTPS 
 
Hypertext Transfer Protocol Secure 
PHI 
 
Personal Health Information 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
ABSTRACT 
Context:   
Motor vehicle crashes are the leading cause of death in teens in the U.S.2, and for drivers 
aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of 
cellphones.1 Nearly 90% of teens expect a response to a text message within 5 minutes, and 
the compulsion to respond is stronger for messages from close social contacts.6 This 
suggests that behavioral-economic interventions such as immediate and frequent incentives 
are needed to offset the disutility caused by not being able to communicate by cellphone 
while driving.7 If proven to be effective, incentives could be scaled up via auto insurance 
discount contributions, school programs, and parental contributions. 
Objectives:  
The objective of this study is to measure whether activation of a cellphone blocking device 
results in a decrease in the frequency of drives in which the phone is unlocked and the total 
proportion of time in which a cellphone is being used at non-zero speeds by teen drivers and 
to determine the incidence of handheld cellphone use while driving and its relationship to 
incoming text messages and driving conditions in a teen driver cohort. 
Study Design:  
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). 
Setting/Participants: 
High school students who are age 16 or 17 at the start of the study that drive an average of 4 
trips per week and hold a valid driver’s licenses will be recruited. Other inclusion criteria 
include living with a parent/guardian, having their own smartphone (iPhone 4S or newer or 
Android 4.3 or newer) with data plan, primarily driving one car, admitting to texting while 
driving at least once in the past month, do not currently use a cellphone blocking app or 
device, and that a parent will be willing to install the device and adjust the settings as 
necessary.  
Study Interventions and Measures:  
A cellphone blocking device (DriveID) will be mailed or given directly to participants. 
DriveID will measure all teen participant cellphone use while the cellphone is in the car for 
the first four weeks. During the intervention period (Weeks 5-8), participants will be placed 
into one of the four conditions (one control, three blocking) that they have been randomized 
to. At the beginning of Week 5, the participant’s DriveID will either be flipped into a 
cellphone blocking mode where the phone will lock when being used while driving or 
remain in a control mode. A two week follow-up phase will occur after the intervention, 
during which participants may choose which group they would like to try. Surveys and an 
interview will also be administered as part of this study.

 
page vi 
  
 
 
 
FIGURE 1: STUDY DIAGRAM 
 
 
 
 
Screening Survey 
~100 potential eligible 
teen driver participants 
Inclusion Criteria: 

High school student 

16 or 17 at start of the study 

Have a valid driver’s license 

Lives in parent’s/guardian’s home 

Drives an average of 4 trips per week 

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 

Do not currently use a cellphone blocking smartphone app or device 
Enroll up to 250 
eligible teen driver 
participants in the field 
study 
Baseline 
Measurement 
Period 
Education Only (Control) 
Opt-in Blocking 
 
Follow-up Period 
4 Week Block 
2 Week Block 
Measurements: 
 
Cellphone use while driving 
 
Participant Survey 
 
Educational Information                                       X 
 
Interview 
 
X          
 
X   
 
 
 
 
   X*                                
X
Opt-out Blocking 
Opt-out Blocking with 
 parental notification 
Intervention Period 
4 Week Block 
X 
Other 
Recruitment 
Efforts 
* Participant chooses mode for 
follow-up phase 

 
 
 
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
In the U.S. in 2012, 3,328 people were killed in crashes involving a distracted driver, 
and an additional 421,000 people were injured (up from 387,000 in 2011).1 Drivers under 
the age of 20 represent the largest proportion of drivers who were distracted. Motor vehicle 
crashes are the leading cause of death in teens in the U.S.,2 and for drivers aged 15-19 
involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones.1 
In a recent New England Journal of Medicine study, the risk of crashes in teen drivers was 3 
to 8 fold higher if the driver was dialing or texting their cellphone,3 an effect similar to 
having a blood alcohol concentration of 0.1 (above the legal limit of 0.08).4 Nearly half of 
U.S. high school students admit to texting while driving in the last 30 days, despite the 
majority knowing that texting while driving is harmful. 
Legal bans, public awareness campaigns, pledges, and a myriad of smartphone apps to 
reduce cellphone use while driving have had little effect on curbing the epidemic.5 One 
reason these efforts have had limited success is that texting has been shown to be a 
compulsion in teens driven by present biased-preferences. Nearly 90% of teens expect a 
response to a text within 5 minutes, and the compulsion to respond is stronger for messages 
from close social contacts, such as a significant other.6 This suggests that behavioral-
economic interventions such as immediate and frequent incentives are needed to offset the 
disutility caused by not being able to communicate by cellphone while driving.7 If proven to 
be effective, incentives could be scaled up via auto insurance discount contributions, school 
programs, and parental contributions. 
1.2 Name and Description of Intervention 
DriveID was released in December of 2013 as a device to overcome a technological barrier 
in being able to accurately measure whether a driver’s cellphone is being used while driving. 
It is a solar-powered Bluetooth signaling technology placed on the car windshield. DriveID 
can measure type of cellphone use while driving and be configured to block a driver’s 
cellphone use while the vehicle is in motion. There is no physical interaction with the 
DriveID device other than installation. 
The device is placed on the windshield and an app is downloaded on to the phone. Online 
configuration of the device settings takes approximately 3-5 minutes. After the initial 
installation, the device is always on and interacts with the user’s cellphone in the 
background. Only the cellphone with the corresponding DriveID application is monitored by 
the DriveID device. The DriveID device directly accesses the vehicle’s driving metrics and 
can be set to lock the phone at speeds as low as 1 mph. Device setup is flexible to allow for 
specific smartphone applications like navigation and maps. The blocking function cannot be 
deactivated without permission of the account holder. 
The study intervention involves randomization into one of four conditions: 1 control 
condition and 3 blocking conditions (opt-in blocking, opt-out blocking, and opt-out blocking 
with parental notification). For the control condition, the device will collect information 
about cell phone use, but no blocking functions will be activated. For opt-in blocking, the 

 
 
 
 
 
 
2
participants will have to initiate the app when entering the vehicle; the blocking settings will 
be pre-set to block incoming calls and text messages only. For opt-out blocking, the device 
will automatically turn on when the teen begins driving and will be set to the same pre-set 
blocking configuration as opt-in blocking. For opt-out blocking with parental notification, 
the device will automatically turn on when the teen begins driving. The blocking settings 
will be pre-set to block all incoming calls and text messages. If teens override the blocking 
feature, a parent/guardian will receive an instant notification in the form of an email. 
Parents/guardians will also have the ability to increase the settings to block outgoing calls 
and all other cellphone functions (i.e. applications). Furthermore, if teens in any condition 
tamper with the DriveID device, delete the corresponding application from their smartphone, 
or disable Bluetooth capabilities, an email will be sent to the parent/guardian and a member 
of the study team. 
1.3 Findings from Non-Clinical and Clinical Studies  
The largest, most rigorous study of the crash risk associated with distraction from 
cellphone use was published in the New England Journal of Medicine in January 2014.  The 
authors conducted two studies on the relationship between the performance of secondary 
tasks, including cell-phone use, and the risk of crashes and near-crashes. To facilitate 
objective assessment, accelerometers, cameras, global positioning systems, and other 
sensors were installed in the vehicles of 42 newly licensed drivers (16.3 to 17.0 years of age) 
and 109 adults with more driving experience.  
During the study periods, 167 crashes and near-crashes among novice drivers and 518 
crashes and near-crashes among experienced drivers were identified. The risk of a crash or 
near-crash among novice drivers increased significantly if they were dialing a cell phone 
(odds ratio, 8.32; 95% confidence interval [CI], 2.83 to 24.42), reaching for a cell phone 
(odds ratio, 7.05; 95% CI, 2.64 to 18.83), sending or receiving text messages (odds ratio, 
3.87; 95% CI, 1.62 to 9.25), reaching for an object other than a cell phone (odds ratio, 8.00; 
95% CI, 3.67 to 17.50), looking at a roadside object (odds ratio, 3.90; 95% CI, 1.72 to 8.81), 
or eating (odds ratio, 2.99; 95% CI, 1.30 to 6.91). Among experienced drivers, dialing a cell 
phone was associated with a significantly increased risk of a crash or near-crash (odds ratio, 
2.49; 95% CI, 1.38 to 4.54); the risk associated with texting or accessing the Internet was 
not assessed in this population. The prevalence of high-risk attention to secondary tasks 
increased over time among novice drivers but not among experienced drivers. 
The authors concluded that the risk of a crash or near-crash among novice drivers 
increased with the performance of many secondary tasks, including texting and dialing cell 
phones. The study was funded by the Eunice Kennedy Shriver National Institute of Child 
Health and Human Development and the National Highway Traffic Safety Administration. 
There is one previous field study using Cellcontrol’s cellphone blocking/filtering 
technology to reduce cellphone use while driving, which was funded by the National 
Highway and Traffic Safety Administration (NHTSA Contract DOT HS 811 863) and 
carried out by investigators at the University of Michigan.  The abstract of the full report 
published online in December 2013 states:  

 
 
 
 
 
 
3
Forty-four participants each received a cell phone filtering/blocking application on 
their employer-provided cell phones for 9 weeks. During the first and last 3 weeks, 
cell phone activity including calling, text messaging and application use was simply 
recorded in the background. During the middle 3 weeks, the cell phone 
filtering/blocking software was active, meaning that anytime the application sensed 
that the phone was moving faster than the pre-set speed threshold, all phone activity 
was blocked. Objective data on participants’ phone use behavior and subjective data 
(from a questionnaire) on participants’ acceptance were collected. Additionally, the 
impact on an organization attempting to implement a similar program employing cell 
phone filtering/blocking was examined. During the blocking period, participants 
initiated a higher proportion of their calls when stopped than when the blocking 
software was inactive. Also, during the blocking period, participants answered a 
much smaller proportion of incoming calls while driving, and outgoing calls were 
placed at a lower mean speed. Participants were neutral in their opinions on whether 
they received a safety benefit from the cell phone blocking. 
1.4 Compliance Statement 
This study will be conducted in full accordance of all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol and will report 
unanticipated problems involving risks to subjects or others in accordance with The 
Children’s Hospital of Philadelphia IRB Policies and Procedures and all federal 
requirements. Collection, recording, and reporting of data will be accurate and will ensure 
the privacy, health, and welfare of research subjects during and after the study. 
2 
STUDY OBJECTIVES 
The purpose of the study is to demonstrate feasibility of conducting a field trial of cellphone 
blocking technology in teen drivers to calculate sample sizes for future trials and generate 
preliminary data for funding applications. Primarily, the proposed is measuring whether 
activation of a cellphone blocking device results in a decrease in the total proportion of time 
in which a cellphone is being used at non-zero speeds by teen drivers. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to determine the feasibility of conducting an on-road 
driving study studying cellphone blocking technologies. 
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
 Measure whether activation of a cellphone blocking device (DriveID) results in a 
decrease in the total proportion of time in which a cellphone is being used at non-zero 
speeds by teen drivers compared with baseline cellphone use while driving. 

 
 
 
 
 
 
4
 Measure the reasons cellphones are being used while driving at non-zero speeds among 
teens (calls, texts, smartphone apps, etc.)  
 Measure teen satisfaction with the cellphone monitoring and blocking device 
 Determine the incidence of handheld cellphone use while driving and its relationship to 
incoming text messages and driving conditions in a teen driver cohort.   
 Measure the number of phone unlocks per hour of drive time 
 Measure the speed of the car, acceleration, and spatial characteristics of phone unlocks 
(ex. on highways vs. at intersections) 
 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a randomized control study of control vs. cellphone blocking conditions. 
3.1.1 Screening Phase 
Participants will also be recruited through posted flyers, postcards, email blasts, through the 
Recruitment Enhancement Core (REC), social media, and by word-of-mouth/colleague 
referrals at Penn and CHOP. The flyers will be posted in a variety of public and private 
locations, including but not limited to, local public and private high schools in suburban and 
local Philadelphia, summer camps, universities, etc. No recruitment will occur through 
schools or public places without first obtaining permission. Postcards will be mailed to 
potentially eligible families identified by the REC and the Penn Social Media & Health 
Innovation Lab. 
The Penn Social Media & Health Innovation Lab will assist with recruitment through a 
variety of social media outlets including Facebook and Craigslist. Language for these 
postings have been included with the application. 
Interested participants will be directed to the Way to Health platform. A parent will create 
an account and consent online. Once consent is obtained, teens will be able to create their 
own account and assent online. Once consent and assent are obtained, teens will be screened 
for eligibility with an eligibility survey presented on the Way to Health platform. Only 
eligibility criteria will be asked. If a participant responds “yes” to all questions, teens will be 
presented with an intake survey on the Way to Health platform. Questions will cover 
demographics, opinions, perceptions and experiences with texting and driving. The teen will 
be asked to email the study team a picture of their driver’s license. A member of the study 
team will also contact the teen to answer any questions and to mail out the CellControl 
device. If a teen is not eligible, the participant will be informed that they are ineligible for 
the current study. 
If participants turn 18 during the duration of the study, they will be re-consented as an adult 
through Way to Health. 

 
 
 
 
 
 
5
3.1.2 Baseline Measurement Period (4 Week Block) 
DriveID will monitor all cellphone use while the teen driver’s cellphone is in the car in 
which DriveID is installed. The application will run in the background, so there will be no 
observable changes to participants’ cellphone functions. DriveID will capture GPS data 
throughout the baseline, intervention, and follow-up periods. At the completion of the fourth 
week, the teen participant will be instructed to complete an online survey administered 
through Penn’s Way to Health IT platform asking about driving behaviors for the first thirty 
days of the study. Participants will have 2 weeks to complete this survey.  
3.1.3 Intervention Period (4 Week Block) 
At the beginning of the intervention period (this will start within 2 business days of baseline 
measurement period survey completion), all participants will receive an email with a link to 
an educational website that raises awareness of the dangers of distracted driving 
(http://enddd.org).  The Children’s Hospital of Philadelphia has performed an independent 
evaluation of the educational content of the website and found it to be evidence based, and 
scientifically guided8.  
DriveID will be used as a cellphone blocking device for those in the three cellphone 
blocking conditions where the phone will lock while driving, but the locking function can be 
overridden according to pre-set settings. DriveID will continue to monitor cellphone use 
while driving including how often the teen unlocks the cellphone as well as if they are using 
the phone for a call or other phone features. However, DriveID is not able to differentiate 
which phone features are being used. 
The study team does not promote texting and driving and encourages all participants to drive 
safely. 
3.1.4 Follow-up Period (2 Week Block) 
At the end of the intervention period, participants will be able to choose a configuration of 
the Cellcontrol (no blocking, opt-in blocking, opt-out blocking, and opt-out blocking with 
parental notification.  Participants will have up to 1 week to choose mode (via phone call, 
survey on Way to Health, or via text message). If a participant does not choose mode, the 
setting will default to remain in what setting the participant was randomized to for the 
intervention period.  We will continue to measure our primary and secondary endpoints.  At 
the completion of the follow-up period or upon voluntary withdrawal from the trial, the teen 
participant will be instructed to complete an online survey administered through Penn’s Way 
to Health IT platform asking about user satisfaction with the device and its configurations. 
Members of the study team may also contact the teen participant to participate in a semi-
structured phone interview conducted by a member of the study team. The interview will be 
audio recorded. 
3.2 Allocation to Treatment Groups and Blinding 
Participants will be randomized to one of four groups. The randomization chart will be 
maintained will be maintained on a secure server that is only accessible by key study 
personnel.. Participants and study staff will be aware of which group they have been 
assigned to. A minimum of five participants will be enrolled into each group. 

 
 
 
 
 
 
6
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject will be approximately 3 months , with up to four weeks of 
Phase 1 (baseline period), up to four weeks Phase 2 (intervention period), and up to two 
weeks Phase 3 (follow-up period). 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study is being conducted at the Children’s Hospital of Philadelphia and the University 
of Pennsylvania. It is expected that up to 250 people will participate in this research study. 
3.4 Study Population 
3.4.1 Inclusion Criteria 
1) High school student (16 or 17 at start of the study) 
2) Holds  a valid driver’s license 
3) Lives in parent/guardian’s home 
4) Drives an average of 4 trips per week 
5) Primarily drive one car 
6) Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan 
7) Parent/guardian is willing to assist with installation 
8) Admits to texting while driving at least once in the last month 
3.4.2 Exclusion Criteria 
1) Already uses a smartphone app or hardware device to limit cellphone use while driving 
 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 Screening Procedure and Online Consent/Assent Process 
Potential participants will either be recruited directly from the eligible participant pool 
surveyed under IRB protocol (#14-11072) or they will be recruited through methods 
discussed in section 9.5. Eligible participants from the previous survey study will be 
contacted by study team members with information about the study. Interested participants 
outside of that study will be directed to the Way to Health Platform to get more information 
on the trial and complete the online consent/assent process.  

 
 
 
 
 
 
7
Teens and parents will be instructed that the parent first needs to create a username and 
password, and create a profile through the WTH platform and then review a consent and 
sign prior to their teen being screened for the trial. The profile on Way to Health asks for 
parent’s contact information and date of birth. We are not collecting this as data, but it is 
required in order to create a WTH profile. After a parent consents for their teen to participate 
they will be instructed to have their teen go to the WTH site and register. Teens will then 
review and sign an assent for the trial. Following this they will be screened with an 
eligibility survey presented on the WTH platform. If a participant responds “yes” to all 
questions they will be allowed to continue in the trial and will be asked to complete the 
intake survey immediately. Questions will cover demographics, opinions, perceptions and 
experiences with texting and driving. They will then continue on with their trial 
participation. If they are not eligible, the participant will be informed that they are ineligible 
for the current study and will not complete any study procedures. These teens will be 
documented as screen failures 
Teens will be asked to email the study team a copy of their driver’s license. A member of 
the study team will then contact the teen and parent/guardian to schedule an in person 
meeting or a phone meeting. During this meeting the study team will answer any questions 
pertaining to the consent or the study and distribute the DriveID device in person or by mail. 
If a participant turns 18 years old during their participation in the study, a member of the 
study team will email the teen a link to complete the online consent via WTH in order to re-
consent. Participants will receive an email or a text message reminder regarding incomplete 
steps in WTH depending on their preference selection for communication. 
The validation of the online consent/assent process will be met during this meeting and 
allow for the fulfillment of one of the study aims: to demonstrate the feasibility and 
effectiveness of an online consent process in order to remotely recruit a larger number of 
participants in future studies among those who purchase the Cellcontrol product. During the 
meeting, a member of the study team will ensure that the participants truly understand the 
risks and benefits of the study. If any participants wish to withdraw, they may do so at this 
time. 
4.2 Device Installation 
Parents will install the DriveID device for the teen participant via instructions provided with 
the device. The DriveID device is installed behind the rearview mirror as to not impede 
vision of the road; the size of the device is approximately 3 inches by 5 inches. The parent 
and teen will also complete online registration of the device. When installation is completed 
correctly, a confirmation message is sent to Cellcontrol. If Cellcontrol receives an error 
message, noting incorrect installation, a member of the study team will contact participants 
to troubleshoot. 
4.3 Study Treatment Phase 
The study treatment phase will consist of three parts: a baseline measurement period, an 
intervention period, and a follow-up period. 

 
 
 
 
 
 
8
4.3.1 Baseline Measurement 
DriveID will measure participants’ cellphone use while the cellphone is in the car in which 
the DriveID device is installed. DriveID will also record GPS data. This data will not be 
accessed in real time by the study team and will only be viewed after the completion of the 
drive. The participants will not have access to the usage data during the baseline period and 
will have no interaction with the device as the monitoring occurs.  
Coded data on primary and secondary endpoints will be automatically uploaded daily 
whenever the phone has a Wi-Fi or cellular data connection to the Cellcontrol server and 
then exported through an encrypted, secure internet connection to Penn’s Way to Health IT 
Platform for management and analysis via linkage of a study ID.   
4.3.2 Intervention 
At the completion of the baseline phase, all participants will receive an email to an 
educational website where they can learn about the dangers of distracted driving 
(http://enddd.org). Teens will also complete a survey. 
Cellcontrol will remotely flip the participant’s DriveID into a cellphone blocking mode for 
those in the three blocking conditions of the study on the first day of the intervention period. 
Teens randomized into the control group will continue with DriveID as is (information 
regarding cell phone use will continue to be collected, but no blocking will occur). In the 
blocking conditions, the phone will lock when being used while driving, but the locking 
function can be overridden.  
Coded data on primary and secondary endpoints will be automatically uploaded daily 
whenever the phone has a Wi-Fi or cellular data connection to the Cellcontrol server and 
then exported through an encrypted, secure internet connection to Penn’s Way to Health IT 
Platform for management and analysis via linkage of a study ID.     
All parents will have the option to check teen’s phone use while the vehicle is in motion on 
the website (https://account.cellcontrol.com/login.php) during weeks five to ten. Parents in 
the opt-out blocking with parental notification group will receive a notification every time 
the phone is being used while the vehicle is in motion.  
4.3.3 Follow-up Phase 
At the completion of the Intervention phase, participants will receive a text message and/or 
email notification that they are eligible change the configuration settings to any of the four 
conditions tested in the trial.  Changes can be made by logging into the Cellcontrol online 
portal. We will collect data on what configuration the participants choose to make during the 
2-week follow-up phase. If a participant does not choose a configuration for the follow-up 
phase after 1 week, the default setting will be to stay in the configuration they are currently 
in.  
4.3.4 Debriefing 
At the completion of the follow-up phase or upon voluntary withdrawal from the trial, the 
participant will be instructed to complete an online survey administered through Penn’s Way 
to Health IT platform asking about user satisfaction with the device. They will receive a link 

 
 
 
 
 
 
9
to the survey through email. If necessary, they may receive reminder calls, emails, or text 
messages from members of the study team for a one month period following study 
completion. The purpose of the survey will be to debrief the participant’s experience with 
the trial, cellphone blocking technology, and suggestions for designing a better trial. For 
subjects that withdrawal prematurely, we will ask about what factors contributed to their 
decision to withdraw early. 
For participants who complete the trial, a member of the study team may contact them to 
complete a brief phone interview. 
4.4 Subject Completion/Withdrawal 
Participants may withdraw from the study at any time. They may also be discontinued from 
the study at the discretion of the Investigators at any time.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Confirmation of Eligibility 
Members of the research team will confirm the eligibility of potential subjects based on the 
inclusion/exclusion criteria noted in Section 3.4 after the online assent process. A parent or 
guardian will first need to create an account on the Way to Health platform and complete 
consent online. Once consent is obtained, teens will need to create an account on the Way to 
Health platform and complete assent. After the participant provides assent, they will be 
presented with a survey to confirm eligibility. If they are eligible, an intake survey will be 
available for teens to complete. A study team member will contact participants to confirm  
eligibility (which will be recorded and retained for all individuals). If subjects are not 
eligible, no other study procedures will occur.  
5.2 Intake Survey 
We will collect the following information on each subject: 
 Demographic characteristics 
 First two digits of the teen’s driver’s license number 
 Month and year of birth 
 Last four digits of the teen’s social security number (for UPenn’s reporting purposes) 
 Opinions and perceptions on texting while driving and associated technology 
5.3 Cellcontrol Data 
Cellcontrol requires users to enter in basic information to set up the account policy.  This 
includes: 
 Username 
 Password 
 Name 
 Phone number 

 
 
 
 
 
 
10
 Email 
The Cellcontrol app currently tabulates the following data which are uploaded securely to 
the Cellcontrol server: 
 Phone talk time while driving 
 Phone usage time while driving (non-talk time phone unlocked and being used for 
apps, texts, email, etc).   
 Phone unlocks while driving 
 Speed the car is traveling when the phone is unlocked 
 Incidence of hard decelerations converted to a “driving score” and hard accelerations 
converted to an “eco score” 
 Number of incoming calls and texts that are blocked  
 GPS, accelerometer, and timestamp data 
5.4 Post-Baseline Survey 
We will collect self-report information on each subject’s driving behaviors for the past thirty 
days in which they were driving in the baseline period. Information includes how often they 
report driving and self-report cell phone use. 
5.5 Teen End of Study Survey 
We will survey participants via the Way To Health platform.  The survey will be constructed 
in Qualtrics, an online survey tool used by Way To Health, to elicit feedback on the 
cellphone locking technology.  Teen subjects will be asked to report: 
 Their feedback on using the cellphone blocking technology 
 Feedback on settings/configurations of the cellphone blocking technology 
 Perceptions of whether their safety had improved with the use of the technology 
 Suggestions for improving the technology and the research study 
 Suggestions for future interventions to promote engaged driving 
A member of the study team may contact participants over the phone to elaborate upon 
responses to the end of study survey questions. 
5.6 Teen Semi-Structured Interview 
We may call participants upon completion of the follow-up period to complete a semi-
structured phone interview. The interview will be conducted by a member of the study team 
and will be recorded by the Penn Mixed Methods Research Lab. The interview will last 
approximately twenty minutes. Teen subjects will be asked questions regarding: 
 
Feedback on each intervention phase of the study (baseline, intervention, and follow-
up) 
 
Suggestions for preventing cellphone distractions while driving 

 
 
 
 
 
 
11
 
If they will continue to use this technology 
5.7 Safety Evaluation 
This is a minimal risk, behavioral intervention study.  Physical risk is no more than the risks 
already caused by distracted driving from handheld cellphone use. The intervention directly 
lowers the risk of distracted driving by blocking incoming phone calls and texts and locking 
the phone while the participant is driving. The participant may unlock the phone in any of 
the conditions with the swipe of a finger where they will then be brought to their typically 
screen. If participants have their phone password protected, they will still need to enter their 
password in order to use the phone. The extra swipe to dismiss the cellphone blocking 
technology is no more dangerous than unlocking the phone normally. 
Participants will have no interaction with the physical DriveID device after installation. 
There are no expected serious adverse events related to the intervention or participation in 
this study.   
6 
STATISTICAL CONSIDERATIONS 
This is a pilot trial with the purpose of demonstrating the feasibility of conducting this type 
of research and generating data in order to estimate sample sizes for future trials.   
6.1 Primary Endpoint 
Frequency of phone unlocks while driving (unlocks/hour) 
6.2 Secondary Endpoints 
Total proportion of time the phone is in use at non-zero speeds  
Seconds of phone use at non-zero speeds 
Seconds of phone use while stopped 
Number of incoming calls and texts that were blocked 
Number of times participants make or receive a phone call, send or read a text message, and 
use any application while driving at non-zero speeds 
Proportion of participants who switched to another blocking configuration in the Follow up 
period 
Participant acceptance of cellphone blocking technology based on post-study survey 
Incidence of handheld cellphone use and its relationship to incoming text messages and 
driving  
In determining feasibility the following will be measured: 
 
Proportion of screen eligible who enroll 
 
Number enrolled per month 
 
Retention rates by study arm 
 
Proportion of surveys completed 

 
 
 
 
 
 
12
 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach and will include all 
subjects randomized at the beginning of the intervention period. 
The primary efficacy endpoint will be the difference in frequency of cellphone unlocks per 
hour of driving between weeks 5 and 8 compared with baseline period weeks 2 to 4.  The 
statistical analysis will use relative change models adjusted for age, sex, state, and presence 
of in-vehicle navigation and phone connectivity systems will compare % change in unlocks 
per hour with 95% confidence intervals in each intervention arm relative to control arm.   
 

 
 
 
 
 
 
13
7 
STUDY INTERVENTION 
7.1 Description 
The study intervention will involve four different conditions to which participants may be 
randomized: 1 control group and 3 blocking groups.  
7.1.1 Education Only (Control) Group 
Participants in the control group will complete the Baseline driving period, but at the end of 
Week 4, instead of DriveID flipping into a blocking mode, the device will remain at baseline 
settings. It will continue to collect information regarding cellphone use while driving in the 
background.  There will be no observable changes to cellphone functions. 
7.1.2 Opt-in Group 
The blocking settings for opt-in group participants will require participants to “opt in” to 
using the blocking features. Blocking settings will be pre-set to block all incoming calls and 
text messages while the vehicle is in motion, but participants will have to initiate the 
blocking when they begin driving by activating the device via the phone app. Participants 
have the ability to override the blocking function while the vehicle is in motion. Number of 
unlocks can be monitored through logging in to the DriveID website. 
7.1.3 Opt-out Group 
The blocking settings for opt-out group participants will turn on by default while driving. 
Blocking settings will be pre-set to block all incoming calls and text messages while the 
vehicle is in motion, but participants will have the ability to override the blocking. Number 
of unlocks can be monitored through logging in to the DriveID website. 
7.1.4 Opt-out Blocking with parental notification Group 
The blocking setting for the opt-out blocking with parental notification group participants 
will turn on by default while driving. The restrictions will be pre-set to block all incoming 
calls and text messages while the vehicle is in motion. Parents/guardians will receive a 
notification every time the teen overrides the block at non-zero speeds. Parents/guardians 
will have the option to also block outgoing calls as well as all other cellphone functions (i.e. 
applications). Number of unlocks can also be monitored through logging in to the DriveID 
website. 
8 
SAFETY MANAGEMENT 
8.1 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review. 

 
 
 
 
 
 
14
Enrolled participants will be provided with contact information of a study team member for 
reporting of any adverse events that occur during data collection. They will be told to 
contact regarding any occurrence they feel is an adverse event, including but not limited to, 
moving violations/citations while participating, traffic accidents, DriveID malfunction, etc. 
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
Participants will be randomized to one of the four condition groups..  A statistician who is 
not involved with enrolling subjects will be responsible for creating the randomization chart. 
We will do block randomization for 8 assignments at a time. Each block will contain the 
four arm assignments repeated once in a random order. We will create a string that is 250 
assignments long. As participants reach the intervention phase they will be assigned to the 
next available assignment in this string. Once an assignment has been used it is no longer 
available to be used. Study staff and participants will not be blinded to the condition.  
Individuals conducting data analyses will use data which blinds them to which group 
participants are in. 
9.2 Data Collection and Management 
 Confidentiality, Security, and Anonymization 
9.2.1 Way To Health 
All personal information that the participant is asked to provide will be collected via Way To 
Health. Way To Health collects subjects’ names, dates of birth, addresses, email addresses, 
phone numbers, and the last four digits of their social security number. They also request the 
name and phone number of an alternate contact. To assure that participant confidentiality is 
preserved, individual identifiers are stored in a single password protected system that is 
accessible only to study research, analysis and IT staff. The last four digits of participants’ 
social security numbers will be stored in a locked cabinet to be destroyed at a later date. An 
investigator or statistician who logs in will be able to access only non-identifiable data. The 
Way To Health administrative group and research coordinators responsible for contacting 
participants for follow-up study visits or responding to questions about the study are able to 
view participant names and contact information.  The WTH web development team and 
Project Director currently have administrative access to PHI. All of these personnel will 
have completed Human Subjects Protection and HIPAA privacy training. The system 
automatically generates logs of all data queries which can be reviewed by research staff to 
ensure that no unauthorized persons have gained access to identifiable information. This 
system is hosted on site at The University of Pennsylvania (UPenn) and is protected by a 
secure firewall and several layers of operational security. Once a participant has been 
entered into this system, they are given a unique study identification number (ID). Any 
datasets and computer files that leave the firewall are stripped of all identifiers and 
individuals are referred to by their study ID. The study ID is also used on all analytical files. 
Data will only be transferred through DriveID, Cellcontrol, Penn's Way to Health IT 
Platform, and the CHOP and Penn study teams. Data will be stored on secure servers both at 

 
 
 
 
 
 
15
CHOP and Penn. Any data transferred between the CHOP and Penn study teams will be 
transferred via encrypted hard drive or secure email.  
9.2.2 Cellcontrol 
Data collected by Cellcontrol through the DriveID device will be manually uploaded by 
members of the study team or directly to Way to Health through secure CSV reports. Data 
will not be tracked in real time. 
9.2.3 Semi-Structured Interview 
The semi-structured interview will be completed by a member of the study team and will be 
recorded by Penn’s Mixed Methods Research Lab. The MMRL provides verbatim 
transcription of individual and group data through Accurate, Dependable, Affordable (ADA) 
transcriptions services. ADA provides secure and confidential data transfers consistent with 
the University of Pennsylvania’s Institutional Review Board data safety standard. ADA 
provides transcription services that are also consistent with federal Health Insurance 
Portability and Accountability Act (HIPAA) guidelines and regulations. The MMRL works 
with ADA to check for accuracy. Once accuracy in transcription is determined, original 
recordings are destroyed 
 
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies on subject privacy and the Investigator and other site personnel will not 
use such data and records for any purpose other than conducting the study. The safeguards 
described above in Section 9.2 will be implemented to ensure subject confidentiality. 
No identifiable data will be used for future studies without first obtaining IRB approval. The 
investigator will obtain a data use agreement between provider (the PI) and any recipient 
researchers (including others at CHOP) before sharing a limited dataset (dates and zip 
codes). 
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
While there is no data monitoring safety board in place for this study as it is a study with 
minimal risk and without medical or biological intervention, the research teams at the 
University of Pennsylvania and the Children’s Hospital of Philadelphia, led by the 
Investigators, will be aware of and will monitor possible areas of risk to the research 
participants. Weekly team meetings will include discussion of any safety and data issues that 
are observed. The PIs will be responsible for monitoring the data and safety. 
9.4.2 Risk Assessment 
Despite care taken in the study design to minimize risk exposure to participants, it is 
acknowledged that there is minimal risk to participants.  
Loss of confidentiality is a potential risk of participating in this study; however, the 
safeguards put in place by Way To Health and the Mixed Methods Research Lab (Section 

 
 
 
 
 
 
16
9.2) will reduce this likelihood. The members of the study teams will follow necessary 
precautions to ensure that all collected data is not shared with unauthorized individuals or 
groups. 
As part of this study, teens will be driving with a cell phone blocking device present and 
operating in the vehicle. These teens are eligible for the study because they admit to texting 
while driving. This study will not require them to interact with their phones while driving 
any more than they would normally choose to on their own. We will encourage teens 
throughout the study to drive safely and not to use their cell phones while driving. 
It is possible that participants may feel uncomfortable answering some of the interview 
questions. They will be made aware before the start of the interview that this is a risk 
associated with participation in the interview and will be reminded that they do not have to 
answer any questions which make them uncomfortable. 
9.4.3 Potential Benefits of Study Participation 
There are no direct benefits from participating in this study.  
9.4.4 Risk-Benefit Assessment 
The gathered information has the potential to increase the understanding of teen’s opinions 
on cellphone blocking technology. The research has the potential to enhance the foundation 
of behavioral change models and improve the quality of continuing education about safety. 
The results may also speak to the benefits of using cellphone blocking devices in-vehicle for 
promoting positive safety behaviors; these benefits outweigh the minimal risk of 
participation in this study.  
9.5 Recruitment Strategy 
Recruitment may occur through a subject pool from IRB #14-11072. Potential participants 
will also be recruited through a variety of strategies. As we are not limited by geographic 
location we will all recruitment strategies on a national level unless otherwise noted.  These 
strategies consist of on-the-ground recruitment strategies (posting posters and flyers in 
visible areas, recruitment through local school districts), direct mailer (email blasts, letter or 
postcard sent to home address), social media (facebook, craigslist, snapchat, etc),  for-profit 
and nonprofit organization partnerships/mentions, media attention (mentions in local and 
national news sources), and word-of-mouth referrals. 
On-the-ground recruitment strategies include posting flyers in areas where teen drivers and 
parents frequent and recruiting through local school boards. These locations will include 
parks, malls, and other after school hangouts. These materials will only be posted in the 
Philadelphia area rather than nationwide.  We will also reach out to local school boards to 
ask about having flyers posted and/or sent to parents in the Philadelphia.  We will contact 
persons in in the district superintendent office to investigate whether they will be willing to 
post theses flyers at schools in their district and/or are willing to mail letters to parents of 
teen drivers in their school district. This will only be done in the Philadelphia area. No 
recruitment will occur through schools or public places without first obtaining permission. 
Letters, postcards, and flyers will consist of the messaging in the letters, postcards, and flyer 
we have attached to this protocol.  

 
 
 
 
 
 
17
We will also recruit participants by mailing letters and doing email blasts to parents of teen 
drivers. We will work with CHOP’s Recruitment Enhancement Core (REC) to contact 
individuals who have visited CHOP and who have teen drivers through direct mailers of 
letter and/or postcards. The REC will also send email blasts to families on our behalf. These 
emails will consist of the messages included in the letters attached to this protocol.  
Social media sources will also be used for recruitment purposes. We plan to use Facebook, 
Craigslist, Twitter, Snapchat, Google, and Instagram in our social media campaign. The 
Penn Social Media & Health Innovation Lab will assist us in using the various social media 
outlets so that we can be as effective as possible in disseminating the recruitment message to 
the correct population. With many of these mediums we will be able to target teens and 
parents with separate ads. In those cases we will provide recruitment ads that are targeted for 
that specific population. In many cases the social media ad that we can use consists of a 
brief message (i.e., Twitter only allows a 160 character message). In these cases the message 
would direct the potential participant to the WTH landing page where they can register. On 
this page we will recreate the full message that is included in the recruitment letters so that 
all participants are well informed of the study details prior to registering for the study. Final 
advertisements and Twitter messages have been attached to this protocol. 
We will be reaching out to many for profit and nonprofit organizations that might be willing 
to help us advertise this study. These organizations include but are not limited to MADD, 
insurance companies, and cell phone companies (other examples: 
madd.org<http://madd.org>, vsofa.org<http://vsofa.org>, 
stoptextsstopwrecks.org<http://stoptextsstopwrecks.org>, 
aaafoundation.org<http://aaafoundation.org>, enddd.org<http://enddd.org>, 
digitalresponsibility.org<http://digitalresponsibility.org>).  We will ask these organizations 
if they would be willing to advertise to consumers using the flyer, letter, or brief mentions 
on their websites. Letters and flyers would be the same as those used for other recruitment 
strategies. Brief mentions would redirect potential participants to the WTH landing page 
where they would read the full recruitment message. 
We will be working with the CHOP ad UPenn media relations offices to learn various ways 
we might get mentions for this study in the press.  We hope that some local and nationwide 
news outlets (Penn News Today, NPR, and other print and online newsletters) will be 
interested in doing a story on the goals of this program and that this media attention will 
help with recruitment. If we are successful in getting media attention the lead Penn PI for 
this study, Kit Delgado, will conduct interviews and ensure that a link to the WTH landing 
page is included in any material produced around the study.  
While all the above recruitment strategies may differ in terms of their approach, message 
length and type, each method will direct all potential participants to the WTH landing page 
where a standard message giving an overview of the program will be posted. That landing 
page text has been included in this protocol as well. It is important to stress that because of 
this method all potential participants will be exposed to the same recruitment message and 
study information prior to registering for the program.  

 
 
 
 
 
 
18
The Recruitment Enhancement Core provides assistance with recruitment plan development 
and will identify and contact potential participants on our behalf using the CHOP Data 
Warehouse, and the CHOP Recruitment Registry. 
9.6 Informed Consent/Assent  
We will require parental consent and teen assent for this trial. Parental consent and 
subject assent for this trial will be obtained via Way to Health.  
Interested participants will be directed to the Way to Health Platform to get more 
information on the trial and complete the online consent/assent process.  
Teens and parents will be instructed that the parent first needs to create a username and 
password through the WTH platform and then review a consent and sign prior to their 
teen being screened for the trial. After a parent consents for their teen to participate they 
will be instructed to have their teen go to the WTH site and register. Teens will then 
review and sign an assent for the trial.  
A member of the study team will then contact the teen and parent/guardian to schedule an 
in person meeting or a phone meeting. During this meeting the study team will answer 
any questions pertaining to the consent or the study and distribute the DriveID device in 
person or by mail. If a participant turns 18 years old during their participation in the 
study, a member of the study team will email the teen a link to complete the online 
consent via WTH in order to re-consent. Participants will receive an email or a text 
message reminder regarding incomplete steps in WTH depending on their preference 
selection for communication. 
The validation of the online consent/assent process will be met during this meeting and 
allow for the fulfillment of one of the study aims: to demonstrate the feasibility and 
effectiveness of an online consent process in order to remotely recruit a larger number of 
participants in future studies among those who purchase the Cellcontrol product. During 
the meeting, a member of the study team will ensure that the participants truly understand 
the risks and benefits of the study. If any participants wish to withdraw, they may do so at 
this time. 
A member of the study team will contact all enrolled participants to ensure understanding 
of study procedures. Electronic signatures will be obtained for both parent and child. 
9.7 Payment to Subjects/Families 
9.7.1 Payment for time and inconvenience (i.e. compensation) 
Participants will be compensated for their time, effort, and inconvenience over the duration 
of the study: 
 
Completion of the intake survey 
 
Successful installation of DriveID 
 
End of Baseline Period (including completion of survey) 
 
End of Intervention Period(including completion of survey) 

 
 
 
 
 
 
19
 
End of Follow up Period(including completion of survey) 
 
End of Drive Survey Teen Interview 
9.7.2 Gifts 
All participants will receive a DriveID device for participation in the study. 
10 PUBLICATION 
We plan to publish the findings in conference proceedings and/or peer-reviewed journals. 
11 REFERENCES 
1) National Highway Traffic Safety Administration. Distracted Driving 2012. Traffic Safety 
Facts Research Note. Available at: http://www.nrd.nhtsa.dot.gov/CATS/index.aspx. 
 
2) Query, C. W. B. I. S. (2010). Reporting System (WISQARS). Atlanta, GA: US 
Department of Health and Human Services, CDC. National Center for Injury Prevention 
and Control.  
 
3) Klauer, S. G., Guo, F., Simons-Morton, B. G., Ouimet, M. C., Lee, S. E., & Dingus, T. A. 
(2014). Distracted driving and risk of road crashes among novice and experienced 
drivers. New England Journal of Medicine, 370(1), 54-59. 
 
4) Leung, S., Croft, R. J., Jackson, M. L., Howard, M. E., & Mckenzie, R. J. (2012). A 
comparison of the effect of mobile phone use and alcohol consumption on driving 
simulation performance. Traffic injury prevention, 13(6), 566-574. 
 
5) Cheng, C., & Meer, J. (2012). The Effect of Cell Phone Bans on Driver Behavior: 
Accidents and Casualties. College Station, TX: Department of Economics, Texas A&M 
University.  
 
6) Atchley, P., & Warden, A. C. (2012). The need of young adults to text now: Using delay 
discounting to assess informational choice. Journal of Applied Research in Memory and 
Cognition, 1(4), 229-234.  
 
7) Loewenstein, G., Asch, D. A., Friedman, J. Y., Melichar, L. A., & Volpp, K. G. (2012). 
Can behavioural economics make us healthier. BMJ, 344(7863), 23-25. 
 
8) Feldman, J. (2014, May 5). Evaluating the Effectiveness of Distracted Driving 
Presentations – Children’s Hospital of Philadelphia (CHOP) and EndDD.org. Retrieved 
from http://enddd.org/distracted-driving-research/childrens-hospital-of-philadelphiachop-
report/