Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse
Phase: PHASE2
Conditions: Child Safety Seat Harness Tension
Sponsor: Minnesota HealthSolutions

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Title: 
Sensor Network with Active Instructional Content to Prevent Child 
Safety Seat Misuse Phase II 
 
Short Title 
Cellular Car Seat (CCS) Study 
Regulatory Sponsor: 
National Institute of Health 
eIRB Number: 
IRB 20-017790 
Protocol Date: 
July 20, 2020 
 
Sponsor 
Minnesota HealthSolutions Corporation 
Minneapolis, MN 
USA 
 
Study Principal Investigator 
Allison E. Curry, PhD, MPH 
The Children’s Hospital of Philadelphia 
2716 South Street, 13th Floor 
Philadelphia, PA, 19146 
Phone: 267-425-1525 
Email: currya@email.chop.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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FIGURE 1: STUDY DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
Confirmation of Eligibility
Verbal Informed Consent
Intake Survey (online)
Study Visit
- Full Install
- Misuse Scenario's #1-3
- Surveys
-Participant Debrief and Remuneration

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INVESTIGATIONAL PLAN 
General Schema of Study Design 
3.1.1 Screening Phase 
Participants in the CHOP care network will be mailed/e-mailed a letter inviting them to participate in the study. 
Interested participants can contact the study team using a dedicated e-mail address and phone number. Participants 
will verbally complete our eligibility screening survey over the phone with a study team member. The solicited 
information from the eligibility screening survey will be limited to the minimum necessary (e.g., just the 
inclusion/exclusion criteria) for screening/determining eligibility for the main study and the screening will be 
brief in duration. Therefore, consent does not apply. 
3.1.2 Study Treatment Phase 
Eligible participants will be asked to verbally consent to study procedures over the phone. Verbal consent will be 
documented in REDCap. Once the participant is enrolled, they will be allocated to either the control or 
intervention group. A research assistant will send the participant an invitation to complete the Intake Survey via 
REDCap prior to the study visit. If participants have not completed this intake survey prior to their study visit, 
they will be asked to complete the survey in-person before moving on to the intervention phase. 
There will be a one-time study visit, which will take place in a study room on the 4th floor of the Roberts Center 
for Pediatric Research. The intervention phase of the visit will take place in a study room on the 4th floor. 
A member of the study team will meet the participant in the Roberts Center for Pediatric Research parking lot or 
lobby. The study team member will escort the family to the 4th floor study room. Next, the team member will 
explain the click tight car seat system and demonstrate it to the participant. The participant will then be asked to 
do a full install of the car seat prior to completing the misuse scenarios. The participant will then be asked to 
complete three misuse scenarios. Participants in the intervention group will use the app while participants in the 
control group will complete the scenarios without the app.  
Misuse scenarios will be evaluated by a member of the study team, including measuring harness tightness with a 
load cell and the pinch test (this will be a yes/no formatted question indicating whether the harness passed the 
slack test) and asking the participant to see the app once they are finished the scenario. In addition, after each 
misuse scenario is complete, participants will be asked to complete a brief survey about their experience. 
Participants will also complete a brief interview at the end of their study visit to understand more about their 
preferences.  
While the first 10 or fewer participants are enrolled, all of the above study procedures will be evaluated to 
understand any complications of using the prototype convertible child safety seat or collecting data that we may 
have not predicted (e.g., not understanding how to read the indicator lights). Therefore, we will be monitoring 
incoming data closely over the first few weeks of the study. If any complications related to the technology or data 
collection methods arise, we will work to solve the issue for the participant(s) and subsequently determine how 
best to prevent this complication to future participants. Considerations for statistical implications of using these 
data are explained in Section 6.3.2 Statistical Considerations. 
Allocation to Treatment Groups and Blinding 
This study will use a control and intervention group. Each enrolled participant will experience each of the three 
misuse scenario’s once.  

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Study Duration, Enrollment and Number of Sites 
Duration of Study Participation 
Enrolled participants will be asked to complete one online intake survey, lasting up to 20 minutes, and one study 
visit, which may last up to 90 minutes, including their post-installation interview. 
Total Number of Study Sites/Total Number of Subjects Projected 
CHOP is the only investigative site for this research study.  
It is expected that approximately 100 participants will be enrolled to produce at least 90 evaluable participants.  
Study Population 
We will seek to recruit at least 25% fathers and ensure a diverse sample of socioeconomic and racial diversity. 
Inclusion Criteria 
Participant/Guardian 
1) Males or females age 18 to 75 years    
2) Has harnessed/fastened a child into a car seat in the last 5 years 
3) Valid drivers license  
 
Exclusion Criteria 
Participant 
1) Participant is not fluent in written and/or spoken English 
2) Participant cannot install a safety seat due to a physical limitation 
STUDY PROCEDURES 
Pre-study Visit 
Screening/Verbal Consent 
A member of the research team will begin by explaining the study to the participant. The participant will be asked 
if they are interested in participating in the study. If interested, the screening questionnaire will be administered 
to determine eligibility. Eligible participants will be asked to consent to study procedures.  
Self-administered Intake Survey 
Participants will receive an invitation to complete the intake survey at their convenience, prior to their study visit. 
Participants will receive both email and phone reminders if the survey has not been completed in advance of their 
scheduled study visit. The intake survey will be hosted within REDCap. If participants have not completed this 
intake survey prior to their study visit, they will be asked to complete the survey in-person before moving on to 
the intervention phase. 
Study Visit  
Study visits will take place at the CHOP Roberts Center for Pediatric Research and will not exceed 90 minutes. 
The following events will take place at the study visits:  

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Click tight technology explanation by study staff  
Initial car seat install- baseline  
First misuse scenario  
Study team assessment 
Reaction Survey 
Second misuse scenario 
Study team assessment 
Reaction Survey 
Third misuse scenario 
Study team assessment 
Reaction Survey 
Preference and Experience interview 
Participant debrief  
Provide participants with remuneration for time and effort 
 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time. CHOP employees will be included as possible study 
participants because many of them are within the study inclusion criteria. To ensure that their study participation 
is completely voluntary, subjects will be assured that their participation is completely voluntary and taking part 
in this research is not a part of their CHOP work or duties. The Investigator may withdraw subjects who violate 
the study plan, or to protect the subject for reasons of safety or for administrative reasons. It will be documented 
whether or not each subject completes the clinical study. If the Investigator becomes aware of any serious, related 
adverse events after the subject completes or withdraws from the study, they will be recorded. 
Early Termination Study Visit 
If a participant withdraws at any point during the Study Visit, they will receive full compensation for their time 
and effort. If a participant withdraws prior to the study visit, they will not receive compensation. 

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STUDY EVALUATIONS AND MEASUREMENTS 
Screening and Monitoring Evaluations and Measurements 
Initial Contact 
Potential participants who learn about our study through our recruitment efforts may reach out to the study team 
if they are interested in participating. They may email or call the study team and leave their contact information. 
Information may include: First and Last Name, Phone Number(s), and Email Address(es). Potential participants 
are not required to provide this information during their initial contact with the study team; however, if provided, 
this information will be collected by the study team to aid in further communication efforts.  
1.1.1 Screening & confirmation of eligibility 
Study research staff will contact participants who respond to our recruitment efforts by phone. These trained staff 
members will describe the intent of the study and what is involved for the participant. The participant will be 
invited to complete a brief, preliminary screening survey in order to determine eligibility for the study. The 
solicited information from the eligibility screening survey will be limited to the minimum necessary (e.g., just the 
inclusion/exclusion criteria) for screening/determining eligibility for the main study and the screening will be 
brief in duration. Therefore, consent does not apply.  
Each screened participant will need to supply their contact information. The following information will be 
collected separately from all other measures: 
• Participant First Name 
• Participant Last Name 
• Home Address 
• Zip Code 
• Phone Number(s) 
• Email Address(es) 
• Contact preferences (e.g., time of day and mode) 
• Participant Date of Birth 
After collecting the information, the research team will assign each participant a unique identification (UID) 
number. This UID will serve to code all subsequent data collection tools. 
Members of the research team will confirm the eligibility of potential participants based on the 
inclusion/exclusion criteria noted in Section 3.4. If the participant chooses not to continue, they will be thanked 
for their time. Confirmation of eligibility will be recorded and retained for all participants using the UID.  
Verbal Consent 
Participants who confirm eligibility and interest in participating will then be asked to verbally consent to study 
procedures. A member of the research team will explain the study to the participant and answer any questions 
they may have. Documentation of verbal consent will be recorded and retained for all participants.  Once the 
participant is enrolled, they will be invited to complete an intake survey, and scheduled for their study visit.  

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5.1.4  Intake Survey 
All participants will complete an intake survey that will collect data on a variety of car seat measures - current 
use, behaviors, knowledge, and preferences; and basic sociodemographics. Measures will include: 
• Age (years) 
• Sex 
• Race/Ethnicity 
• Self-reported crash history of self  
• Household income 
• Previous experience installing safety seats and harnessing children into them 
• Risk perceptions about child occupant safety 
• Barriers and facilitators to safety seat use 
• Knowledge and attitudes about existing child occupant safety programs and policies 
 
Efficacy Evaluations  
5.2.3 Harness Installations & Assessments 
Each participant will complete three (3) misuse scenarios using child safety seats during the study visit.  
The assessment of each misuse scenario (n=3) will capture the following information: 
Method of harness (e.g., direction of pull to tighten, if the participant checks the tightness or makes adjustments, 
if participant asks child about tightness) 
Length of time (in seconds) to harness 
Tightness of harness in control seat (measured by a load cell and pinch test) 
Tightness of harness in intervention seat (measured by the number of lights achieved in tensioning, a load cell 
and pinch test) 
Difficulties observed (e.g., participant is unable to get child to cooperate, participant is unable to tighten harness 
because of physical limitations, or angle of seat makes it difficult to harness child) 
Errors present at end of scenario 
A series of questions for the participant on their experience during the scenario 
1.1.2 Post-observation interview 
We will collect the following information from each participant in an interview format after completing all zthree 
scenarios. Surveys may be collected via paper or direct data entry into REDCap. Interviews may be recorded on 
video. 
• Facilitators or barriers they experienced while installing and harnessing the doll into the seat 
• Ease of installation and harnessing 
• What they liked or did not like about the app 
• Belief of correct instillation and harnessing technique 
• Perceived errors in each scenario  
 

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STUDY DEVICE 
Description 
The proposed innovative child safety seat user engagement system designed to actively educate, instruct and 
alarm caregivers with information associated with automatically-sensed safety seat misuses/errors is highly 
innovative and address an important unmet need. The goal is to prevent child safety seat critical misuses and 
reduce deaths and injuries in children riding in motor vehicles. Critical misuses are a major public health 
concern and include: improper child weight for seat type, improper seat orientation, insecure attachment of the 
seat to the vehicle, and insecure harnessing of the child. Parental education, how, when, or where parents 
learned to install seats, and improved graphics/labeling on seats/manuals have been observed to have no 
significant effect on many critical misuses. Better systems are needed to improve the rate of proper seat use. 
A key enabling technology that makes the proposed sensor system possible at this time is newly-available 
extremely low-cost cellular radio modules that can achieve secure internet connectivity directly from the seat. 
This cellular radio will be built into an inexpensive pre-configured sensor system capable of sensing key state-
of- use information, including the most common critical misuses, to automatically push usage and 
environmental information to a cloud-based server. The use of cellular technology eliminates the need for users 
to pair the seat with a cell phone or wi-fi network to achieve connectivity: the sensor system will operate right 
out of the box. 
 
SAFETY MANAGEMENT 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any unanticipated 
problems related to the 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.  
 
STUDY ADMINISTRATION 
Treatment Assignment Methods 
Randomization 
Participants will be randomly assigned to either the intervention group or control group upon their arrival to the 
study visit. The randomization sequence was generated using SAS software, version 9.4 (SAS Institute, Cary, 
NC, USA). 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with CHOP Institutional 
policies and HIPAA on subject privacy.  
The Investigator and research staff will not use such data and records for any purpose other than conducting the 
study. The research staff will utilize safeguards to protect subject confidentiality, including assigning a UID to 
each subject and keeping identifiable information separate from all other coded study measurements.  

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No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain 
a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at 
CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).  
Potential Benefits of Participation 
Participants may benefit indirectly through the findings from this study that may help to improve correct use of 
child safety seats.  
At the end of the study visit, participants will be provided with resource sheet with some tips and links to resources 
about how to correctly harness a child into a child safety seat, such as the CHOP site: 
https://www.chop.edu/centers-programs/car-seat-safety-kids. Participants will not receive custom feedback about 
their harness installation, since not all members of the study team are certified Child Passenger Safety 
Technicians.  
Risk-Benefit Assessment 
There are very minimal risks involved with participating in this study.  There may or may not be any direct 
benefits for participating in this study. There is a possibility that a loss of confidentiality may occur as a result of 
participating in this study.  However, this risk will be minimized by removing all individually identifiable 
information from any study reports, publications or presentations (see section 9.2 for further details on data 
storage and protection). Therefore, the potential direct and/or indirect benefits of participation exceed the minimal 
risk of participation. 
Recruitment Strategy 
Participants will be recruited using a variety of methods. Our primary recruitment mechanism will be the CHOP 
Recruitment Enhancement Core (REC). The REC will e-blast possible participants with necessary recruitment 
information. We may also use the Pediatric Research Consortium (PeRC) for additional recruitment if needed to 
attain the sample size needed. Additionally, flyers and tear-pads may be posted in areas frequented by individuals 
in target groups (e.g., local shopping areas where allowed, on CHOP campus) as well as on websites and social 
media. The ad which has been prepared for websites will be posted on a number of websites frequented by local 
residents of our target population, including (but not limited to): CHOP network website and other CHOP 
affiliated sites and Facebook. Lastly, an email blast will be sent to a large portion of faculty and staff as well as 
other members of the CHOP care network. 
Informed Consent/Assent and HIPAA Authorization 
Eligibility Screening Conversation 
To effectively screen participants and to ensure inclusion and exclusion criteria are met prior to study visit 
scheduling, a waiver of documentation of screening consent has been requested. Study staff will only collect the 
minimum necessary information to determine eligibility. Participants will be given a detailed description of the 
study and have the opportunity to indicate whether they are interested in continuing to the consenting procedures.  
Main Study Consent 
Participants will provide informed consent over the phone before completing the intake questionnaire. The study 
will use a combined Informed Consent Form/HIPAA Authorization. Verbal consent will be documented in 
REDCap. Participants will be able to print or receive an e-mailed copy of the Informed Consent Form/HIPAA 
Authorization. It will explain all relevant study procedures and provide contact information for study staff. The 
research presents minimal risk to participants and involves no procedures for which written consent is normally 
required outside of the research context. 

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The research staff will encourage subjects to ask questions regarding the study and consenting process. 
Participants will have as much time as needed to make a decision regarding participation. Participation will be 
strictly voluntary and participants can withdraw for any reason at any time. As part of the consenting process 
subjects will be given the option to provide permission for future use of collected data and for future contacts by 
CHOP about upcoming research opportunities or other events.  
Payment to Subjects 
Reimbursement for travel, parking and meals 
Parking vouchers will be provided to each study participant. The cost for the study team to purchase one of these 
vouchers if $5/voucher, but no costs will be incurred by the participant. Participants will not be reimbursed for 
their travel to the Roberts Center for Pediatric Research and no meals will be provided given the brevity of the 
visit. 
Payments to participant for time and inconvenience (i.e. compensation) 
Each participant will be compensated for their participation in this study. Following completion of the study visit, 
or withdrawal during the study visit, participants will be compensated $50. Remuneration will be provided in the 
form of a CHOP-issued participant research card. 
PUBLICATION 
CHOP and MHS investigators will have complete access to all study data and will publish results of the study in 
the form of manuscripts which will be submitted to the peer-reviewed scientific literature in journals relevant to 
the topic area.