Improving Child Restraint Installation in Rural America Through Interactive Virtual Presence
Phase: NA
Conditions: Car Seat Installation
Sponsor: University of Alabama at Birmingham

 
 
 
 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: Improving Child Restraint Installation 
 
NCT Number: NCT03508843 
 
Document Date: August 23, 2019 
 
 

Study Protocol 
All study procedures were conducted at Safe Kids Coalition community car seat check 
events at public locations such as health clinics, shopping centers, and local parks. Following 
consent processes, participants completed an electronic baseline questionnaire on a study tablet 
addressing participant and family demographics and perceptions of CRS use. While participants 
completed the questionnaire, an onsite CPST inspected the CRS and rated the accuracy of seat 
selection, installation, and child positioning, as detailed below. Participants were not informed 
about the results of the initial inspection until after the study was complete. If more than one 
CRS was present in the vehicle, a “target” CRS for the research was randomly chosen and 
standard in-person CPST consultations were provided for the remaining CRS following 
completion of the study. When child passengers were present, height and weight measurements 
were taken onsite; otherwise caregivers estimated their child’s measurements. 
After baseline measures were complete, participants installed Help Lightning, a 
commercially available IVP app, on their smartphones using WiFi provided by the study. 
Participants received instruction from onsite study personnel on how to connect to an off-site 
CPST via the app to initiate the remote consultation. The remote CPST placed participants in 
“Receive Help” mode and themselves in “Give Help” mode, which allowed the remote CPST to 
draw on the live video image and superimpose their hands on the image to signal and indicate 
relevant features of the CRS and vehicle while the participant observed the merged image. 
Participants and remote CPST could also communicate verbally throughout the consultation. 
No technical concerns about the app's functioning were expressed by participants or 
remote CPST, but weak internet connections in some rural areas led to occasional dropped calls. 
On the rare occasions when contact was disconnected, the remote CPST immediately re-
contacted the participant and resumed instruction. The remote CPST instructed all caregivers on 
how to inspect their CRS selection and installation and provided corrective feedback when 
necessary. In most cases, this involved removing the CRS from the vehicle entirely and re-
installing it. New CRS were available onsite for an income-adjusted fee ($0-$25) if errors in seat 
selection were identified that required a new CRS to correct. When the child passenger was 
present, the remote CPST also instructed the caregiver on how to inspect their positioning of the 
child in the CRS. 
Following the remote consultation, the onsite CPST again inspected the CRS 
using an objective rating scale while participants completed a post-intervention questionnaire 
assessing their perceptions of the remote consultation and CRS installation process. Prior to 
departure, all CRS in the vehicle (including those not randomly selected as the “target” for 
research purposes if multiple CRS were present) were re-inspected for safety. If needed, 
participants were assisted with re-installation by the onsite CPST. Participants were offered $40 
cash payment to reimburse them for their time. All onsite and remote CPST held active CPST 
certification from Safe Kids.  
Coding Accuracy of CRS Use 
Onsite CPST used a structured coding sheet to rate the accuracy of caregiver’s seat 
selection, installation, and child positioning before and after remote CPST consultation. Baseline 
installation was only coded when the CRS arrived secured to the vehicle (versus in the original 
packaging or loose in the vehicle). Child positioning was only coded at baseline and post-
intervention when the child passenger for the target CRS was present.  
The initial development of the coding sheet is detailed elsewhere (Schwebel, Tillman et 
al., 2017). Items include criteria from the Safe Kids Worldwide Child Passenger Safety Checklist 

and other best practice guidelines. Minor revisions to the previously published coding sheet 
(Schwebel, Tillman et al., 2017) were made iteratively through input from multiple expert 
researchers in child safety and injury prevention, including four certified CPST. Coding criteria 
for four child restraint types and installations were developed, representing rear- and forward-
facing CRS and installation with lower anchors or seat belts. Seat selection was evaluated with 
six items and child positioning was evaluated with five items for all CRS. Installation was 
evaluated with 15-19 items, depending on the CRS type and installation method. All coding 
items are presented in Table 1. When items were not relevant to a particular CRS or vehicle, they 
were omitted.  
Data Analysis 
Data analyses were conducted separately for CRS selection, installation, and child 
positioning. Each analysis included only those participants with both baseline and post-
intervention data for that analysis. Participants were classified as making no errors or making 
one or more errors within each category. McNemar’s tests were used to evaluate significant 
changes in the proportion of participants with no errors from baseline to post-intervention. 
Descriptive statistics were used to specify participant characteristics and the errors in CRS use 
made by participants at baseline and post-intervention.