Swivel Convertible Child Safety Seat to Improve Usage

Phase II - Modular Convertible Child Safety Seat to Improve Usage

Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat.

Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat.

Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.

Study Overview

• Status: Not yet recruiting
• Conditions: Motor Vehicle Injury
• Intervention / Treatment: Other: Modular child restraint

Detailed Description

Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Julie Mansfield, PhD; Phone Number: 614-366-2101; Email: julie.mansfield@osumc.edu
• Study Contact Backup: Name: Sara Seifert; Email: sara@minnhealth.com

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
      • Contact: Julie Mansfield, PhD; Phone Number: 614-366-2101; Email: julie.mansfield@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from the Central Ohio area. Adults who meet the above criteria will be enrolled.

Description

Inclusion Criteria:

• Between the ages of 18 and 65
• Care provider to a child who is up to 4 years of age
• Have installed a child safety seat in the last 2 years
• Able to lift and install a child safety seat into a vehicle
• English speaking.

Exclusion Criteria:

• Not meeting any of the above

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study population; Participants must be a caregiver to a child age 4 or under, have experience installing a child safety seat within the past 2 years, and be physically healthy enough to install two child seats for the study.

Other: Modular child restraint; The participant will be asked to install two different child safety seats into a vehicle, presented to the participant one at a time (random order). The researcher will explain that the participant should install each seat to the best of his/her ability and may take as long as needed. When each installation is completed, the participant will be led away from the vehicle while their work is evaluated by a study-team approved researcher who is a certified Child Passenger Safety Technician (CPST). A data collection form will be used to document any installation errors. Following the installations, participants will complete a short survey with open-ended queries to describe facilitators or barriers they experienced while installing the seats, as well as what they liked or did not like about each seat. They will use a Likert scale to rate their self-efficacy in installing the seats, if they believed they were installed correctly, general ease-of-use, and which seat they preferred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct use of top tether, prototype seat	Number of participants who correctly install the top tether in the prototype swivel seat	1 study visit, an average of 30 minutes
Correct use of top tether, traditional seat	Number of participants who correctly install the top tether in the traditional seat	1 study visit, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct overall installation, prototype seat	Number of participants who correctly install the prototype swivel child seat, considering all types of possible errors	1 study visit, an average of 30 minutes
Correct overall installation, traditional seat	Number of participants who correctly install the traditional child seat, considering all types of possible errors	1 study visit, an average of 30 minutes
Opinion on modular child seat design and instructions	Number of participants who rate the usability of the prototype swivel seat at least as high or higher than the traditional seat	1 study visit, an average of 30 minutes

Collaborators and Investigators

• Sponsor: Minnesota HealthSolutions
• Investigators: Principal Investigator: Julie Mansfield, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MinnesotaHealthSolutions_Swiv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon request after publication of the results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No