Trial Outcomes & Findings for Safety-Enhancing Motor Vehicle Child Safety Seat (NCT NCT06384989)

NCT ID: NCT06384989

Last Updated: 2025-04-16

Results Overview

Number of participants who correctly install the load leg independently, without needing any prompt to use it.

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 study visit, an average of 30 minutes
• Results posted on: 2025-04-16

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety-Enhancing Motor Vehicle Child Safety Seat

Baseline characteristics by cohort

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	35.5 years STANDARD_DEVIATION 7.2 • n=93 Participants
Sex: Female, Male Female	36 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants
Race (NIH/OMB) White	37 Participants n=93 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	50 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Overall Correct Use of Load Leg	18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Attempt to Use Load Leg Without Prompting	27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Correct Load Leg Length	35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Correct Load Leg Angle	37 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Correct Understanding of Load Leg's Purpose	48 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single-group Study n=50 Participants All 50 participants were part of a single group. Their interactions with/installations of the prototype child seat with a load leg were observed.
Participants Who Like Having the Load Leg	28 Participants

Adverse Events

Single-group Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Mansfield

The Ohio State University

Phone: 614-366-2101

Email: julie.mansfield@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place