NCT06866171

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

March 4, 2025

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

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.

Study population

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Not meeting any of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Julie Mansfield, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Mansfield, PhD

CONTACT

Sara Seifert

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data will be available upon request after publication of the results.

Locations