Clinical trial NCT06866171: Swivel Convertible Child Safety Seat to Improve Usage
Official title: Phase II - Modular Convertible Child Safety Seat to Improve Usage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Motor Vehicle Injury
Lead sponsor: Minnesota HealthSolutions
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correct use of top tether, prototype seat
timeFrame: 1 study visit, an average of 30 minutes
measure: Correct use of top tether, traditional seat
timeFrame: 1 study visit, an average of 30 minutes
Secondary outcomes:
measure: Correct overall installation, prototype seat
timeFrame: 1 study visit, an average of 30 minutes
measure: Correct overall installation, traditional seat
timeFrame: 1 study visit, an average of 30 minutes
measure: Opinion on modular child seat design and instructions
timeFrame: 1 study visit, an average of 30 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Julie Mansfield, PhD
role: PRINCIPAL_INVESTIGATOR
References: