- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384989
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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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