Safety-Enhancing Motor Vehicle Child Safety Seat

March 28, 2025 updated by: Julie Mansfield, Minnesota HealthSolutions

Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat

This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design.

Study Overview

Detailed Description

A descriptive study will be conducted to determine whether human subjects are able to install the new feature of the prototype car seat correctly. Participants will be presented with the prototype car seat and a set of basic written instructions and labels to guide their installations. The percentage of participants who use the new feature and use it correctly will be reported. Any installation errors on other parts of the child seat (seat belt, lower anchors, top tether) will also be reported.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Efforts will be made to include both males and females, across a range of ages, as well as minorities, as these groups' experiences around child seats may vary.

Description

Inclusion Criteria:

  • Age 18 or older
  • Be a 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 (because consent forms and explanation will be given in English)

Exclusion Criteria:

  • Not meeting any of the above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Correct Use of Load Leg
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who correctly install the load leg independently, without needing any prompt to use it.
1 study visit, an average of 30 minutes
Attempt to Use Load Leg Without Prompting
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who noticed the load leg on their own, unfolded it from storage, and attempted to use it without being prompted by the researcher.
1 study visit, an average of 30 minutes
Correct Load Leg Length
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who set the load leg to the correct length, including those who needed prompted to use it
1 study visit, an average of 30 minutes
Correct Load Leg Angle
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who set the load leg to the correct angle, including those who needed prompted to use it.
1 study visit, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct Understanding of Load Leg's Purpose
Time Frame: 1 study visit, an average of 30 minutes
The number of participants who correctly understood the purpose of the load leg by using words such as "security, safety, stability," etc. in their survey responses.
1 study visit, an average of 30 minutes
Participants Who Like Having the Load Leg
Time Frame: 1 study visit, an average of 30 minutes
Number of participants who overall reported that they would like having the load leg feature on a child seat.
1 study visit, an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie Mansfield, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2024

Primary Completion (Actual)

July 29, 2024

Study Completion (Actual)

July 29, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MinnesotaHealthSolutions_LL

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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