Motor Vehicle InjuryNCT06384989
Safety-Enhancing Motor Vehicle Child Safety Seat
An observational study of Motor Vehicle Injury and Safety Issues, run by Minnesota HealthSolutions at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Vehicle Injury, Safety Issues
- What is being tested?
- Child restraint system with load leg feature
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 29 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Not meeting any of the above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motor Vehicle Injury, Safety Issues
- Being tested
- Child restraint system with load leg feature
- Keywords
- child restraint system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child restraint system with load leg featureOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Correct Use of Load Leg
Number of participants who correctly install the load leg independently, without needing any prompt to use it.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 study visit, an average of 30 minutes
Secondary outcomes (2)
Correct Understanding of Load Leg's Purpose
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.
Measured: 1 study visit, an average of 30 minutes
Participants Who Like Having the Load Leg
Number of participants who overall reported that they would like having the load leg feature on a child seat.
Measured: 1 study visit, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 May 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Motor Vehicle InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota HealthSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Julie Mansfield, Minnesota HealthSolutions
- Investigators
- Julie Mansfield, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384989
- Sponsor's protocol ID
- MinnesotaHealthSolutions_LL
- Status last verified
- Mar 2025
- First submitted
- 18 Apr 2024
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request after publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat
- ClinicalTrials.gov ID
- NCT06384989
- Acronym / sponsor ID
- MinnesotaHealthSolutions_LL
- Conditions
- Motor Vehicle Injury, Safety Issues
- Keywords
- child restraint system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minnesota HealthSolutionsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Not meeting any of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child restraint system with load leg featureThe 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. | Other | – |
Primary outcome
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.
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.
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
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.
2 secondary outcomes
Correct Understanding of Load Leg's Purpose
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be available upon request after publication of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Mansfield, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Vehicle Injury and Safety Issues, run by Minnesota HealthSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Correct Use of Load Leg (time frame: 1 study visit, an average of 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.