Phase II - Modular Convertible Child Safety Seat to Improve Usage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Correct use of top tether, prototype seat
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Correct use of top tether, prototype seat
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the prototype swivel seat
Correct use of top tether, traditional seat
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the traditional seat
Secondary Outcomes
- Correct overall installation, prototype seat(1 study visit, an average of 30 minutes)
- Correct overall installation, traditional seat(1 study visit, an average of 30 minutes)
- Opinion on modular child seat design and instructions(1 study visit, an average of 30 minutes)
Investigators
Julie Mansfield
Research Associate Professor
Minnesota HealthSolutions