Clinical trial NCT05552027: Minnesota HealthSolutions Cellular Car Seat Study
Official title: Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Child Safety Seat Harness Tension
Lead sponsor: Minnesota HealthSolutions
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Philadelphia
name: University of Alabama at Birmingham
First posted: 2022-09-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Installation Errors
timeFrame: Once during the only study visit: up to 30 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Minnesota HealthSolutions
name: Sara Seifert, MPH
role: PRINCIPAL_INVESTIGATOR
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