Minnesota HealthSolutions Cellular Car Seat Study

Study Overview
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Brief Summary
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The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.

Detailed Description
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The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short how to instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.

Official Title
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Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse

Conditions
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Child Safety Seat Harness Tension

Intervention / Treatment
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* Device: CCS System- Prototype
* Device: CCS System- Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or Females ages 18-75 years Has harnessed/fastened a child into a car seat in the last five (5) years Has a valid driver's license Exclusion Criteria: Non-fluency in written and/or spoken English Participant cannot install a safety seat due to a physical or health limitation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized control trial with 2 arms (intervention and control). The intervention group will participate in a series of three safety seat misuse scenarios with the CCS system enabled, and participants in the control group will participate in the same series of three safety seat misuse scenarios without the CCS system. Misuse scenarios include insecure attachment of the seat to the vehicle, incorrect harness straps, and improper orientation of the safety seat. In each scenario, participants will be asked to identify and correct each error. Each participant will be randomly assigned to either the control or intervention group. Each participant will receive the same scenarios in the same order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback. | Device: CCS System- Prototype<br>* Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)<br>|
| Other: Control<br>Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback. | Device: CCS System- Control<br>* The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with installation errors | For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no). | once during the only study visit: up to 30 mins |