Motor Vehicle InjuryNCT06866171
Swivel Convertible Child Safety Seat to Improve Usage
An observational study of Motor Vehicle Injury, run by Minnesota HealthSolutions at 1 site in United States.
Trial summary
Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Vehicle Injury
- What is being tested?
- Modular child restraint
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 4 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- 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.
Who may be able to join
- Between the ages of 18 and 65
- 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.
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 - Modular Convertible Child Safety Seat to Improve Usage
Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat.
Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat.
Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.
Read the detailed description
Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.
- Conditions
- Motor Vehicle Injury
- Being tested
- Modular child restraint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular child restraintOther
The participant will be asked to install two different child safety seats into a vehicle, presented to the participant one at a time (random order). The researcher will explain that the participant should install each seat to the best of his/her ability and may take as long as needed. When each installation is completed, the participant will be led away from the vehicle while their work is evaluated by a study-team approved researcher who is a certified Child Passenger Safety Technician (CPST). A data collection form will be used to document any installation errors. Following the installations, participants will complete a short survey with open-ended queries to describe facilitators or barriers they experienced while installing the seats, as well as what they liked or did not like about each seat. They will use a Likert scale to rate their self-efficacy in installing the seats, if they believed they were installed correctly, general ease-of-use, and which seat they preferred.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Participants must be a caregiver to a child age 4 or under, have experience installing a child safety seat within the past 2 years, and be physically healthy enough to install two child seats for the study. Receives: Other: Modular child restraint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct use of top tether, prototype seat
Number of participants who correctly install the top tether in the prototype swivel seat
Measured: 1 study visit, an average of 30 minutes
Correct use of top tether, traditional seat
Number of participants who correctly install the top tether in the traditional seat
Measured: 1 study visit, an average of 30 minutes
Secondary outcomes (3)
Correct overall installation, prototype seat
Number of participants who correctly install the prototype swivel child seat, considering all types of possible errors
Measured: 1 study visit, an average of 30 minutes
Correct overall installation, traditional seat
Number of participants who correctly install the traditional child seat, considering all types of possible errors
Measured: 1 study visit, an average of 30 minutes
Opinion on modular child seat design and instructions
Number of participants who rate the usability of the prototype swivel seat at least as high or higher than the traditional 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 posted10 Mar 2025
- Study start28 Oct 2025
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 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
- NCT06866171
- Sponsor's protocol ID
- MinnesotaHealthSolutions_Swiv
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II - Modular Convertible Child Safety Seat to Improve Usage
- ClinicalTrials.gov ID
- NCT06866171
- Acronym / sponsor ID
- MinnesotaHealthSolutions_Swiv
- Conditions
- Motor Vehicle Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minnesota HealthSolutionsIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat.
Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat.
Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.
Detailed description
Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Modular child restraintParticipants must be a caregiver to a child age 4 or under, have experience installing a child safety seat within the past 2 years, and be physically healthy enough to install two child seats for the study. |
Who may qualify
- Ages
- 18 to 65 years
- 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.
Key inclusion criteria (5 listed)
- Between the ages of 18 and 65
- 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.
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 |
|---|---|---|
| Modular child restraintThe participant will be asked to install two different child safety seats into a vehicle, presented to the participant one at a time (random order). The researcher will explain that the participant should install each seat to the best of his/her ability and may take as long as needed. When each installation is completed, the participant will be led away from the vehicle while their work is evaluated by a study-team approved researcher who is a certified Child Passenger Safety Technician (CPST). A data collection form will be used to document any installation errors. Following the installations, participants will complete a short survey with open-ended queries to describe facilitators or barriers they experienced while installing the seats, as well as what they liked or did not like about each seat. They will use a Likert scale to rate their self-efficacy in installing the seats, if they believed they were installed correctly, general ease-of-use, and which seat they preferred. | Other | Study population |
Primary outcome
Correct use of top tether, prototype seat
Time frame: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the prototype swivel seat
Correct use of top tether, traditional seat
Time frame: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the traditional seat
3 secondary outcomes
Correct overall installation, prototype seat
Time frame: 1 study visit, an average of 30 minutes
Correct overall installation, traditional seat
Time frame: 1 study visit, an average of 30 minutes
Opinion on modular child seat design and instructions
Time frame: 1 study visit, an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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, 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 9 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correct use of top tether, prototype seat (time frame: 1 study visit, an average of 30 minutes). The study lists 2 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 9 Oct 2026.