Safety-Enhancing Motor Vehicle Child Safety Seat

Safety Issues Clinical Trial

Official title:

Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384989
• Other study ID #: MinnesotaHealthSolutions_LL
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Minnesota HealthSolutions
• Contact: Julie Mansfield, PhD
• Phone: 614-366-2101
• Email: Julie.Mansfield[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 15, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motor Vehicle Injury
• Safety Issues

Intervention

Other:
• Child restraint system with load leg feature
The primary objective is to assess the usability of the 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 (especially related to the use of the load leg) and to assess participants' opinions on the car seat's load leg design.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Minnesota HealthSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct use of load leg	Number of participants who correctly install the load leg	1 study visit, an average of 2 hours
Primary	Load leg error types	Types and descriptions of load leg installation errors	1 study visit, an average of 2 hours
Secondary	Other installation errors	Frequencies and descriptions of other child seat installation errors (belt routing, looseness of attachment, etc.)	1 study visit, an average of 2 hours
Secondary	Opinion on load leg design and instructions	Qualitative feedback from participants regarding their opinion on the load leg design and ease of use. Questions are open response format (e.g., what do you like about the load leg? What do you not like about it?, etc.)	1 study visit, an average of 2 hours