Safety-Enhancing Motor Vehicle Child Safety Seat

Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06384989

Enrollment

Registered

2024-04-25

Start date

2024-05-22

Completion date

2024-07-29

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Vehicle Injury, Safety Issues

Keywords

child restraint system

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.

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.

Interventions

OTHERChild 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Correct Use of Load Leg	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.
Attempt to Use Load Leg Without Prompting	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.
Correct Load Leg Length	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
Correct Load Leg Angle	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.

Secondary

Measure	Time frame	Description
Correct Understanding of Load Leg's Purpose	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.
Participants Who Like Having the Load Leg	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Single-group Study All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.	50
Total	50

Baseline characteristics

Characteristic	Single-group Study
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	50 Participants
Age, Continuous	35.5 years STANDARD_DEVIATION 7.2
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	37 Participants
Region of Enrollment United States	50 Participants
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	14 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 50
other Total, other adverse events	0 / 50
serious Total, serious adverse events	0 / 50

Outcome results

Primary

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.