Minnesota HealthSolutions Cellular Car Seat Study

Phase 2

Completed

• Conditions: Child Safety Seat Harness Tension

• Registration Number: NCT05552027
• Lead Sponsor: Minnesota HealthSolutions

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Installation Errors	Once during the only study visit: up to 30 mins	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).

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States