NCT06384989

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 16, 2025

Completed
Last Updated

April 16, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

April 18, 2024

Results QC Date

March 4, 2025

Last Update Submit

March 28, 2025

Conditions

Keywords

child restraint system

Outcome Measures

Primary Outcomes (4)

  • Overall Correct Use of Load Leg

    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

    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

    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

    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 Outcomes (2)

  • Correct Understanding of Load Leg's Purpose

    1 study visit, an average of 30 minutes

  • Participants Who Like Having the Load Leg

    1 study visit, an average of 30 minutes

Interventions

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.

Eligibility Criteria

Age18 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. 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.

You may qualify if:

  • 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)

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

MeSH Terms

Interventions

Child Restraint Systems

Intervention Hierarchy (Ancestors)

Infant EquipmentEquipment and SuppliesProtective DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Julie Mansfield
Organization
The Ohio State University

Study Officials

  • Julie Mansfield, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 25, 2024

Study Start

May 22, 2024

Primary Completion

July 29, 2024

Study Completion

July 29, 2024

Last Updated

April 16, 2025

Results First Posted

April 16, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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

Locations