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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Child restraint system with load leg feature | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 study visit, an average of 30 minutes |
| Participants Who Like Having the Load Leg |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Julie Mansfield, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
Data will be available upon request after publication of the results.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Correct Use of Load Leg | Number of participants who correctly install the load leg independently, without needing any prompt to use it. | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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During study tasks which took approximately 30 minutes to complete. The study involved minimal risk only. Participants installed a child seat into a vehicle, which is a typical task of adults and caregivers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Mansfield | The Ohio State University | 614-366-2101 | julie.mansfield@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2024 | Mar 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057207 | Child Restraint Systems |
| ID | Term |
|---|---|
| D015370 | Infant Equipment |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D008420 | Manufactured Materials |
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Number of participants who overall reported that they would like having the load leg feature on a child seat. |
| 1 study visit, an average of 30 minutes |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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| Primary | Correct Load Leg Length | Number of participants who set the load leg to the correct length, including those who needed prompted to use it | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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| Primary | Correct Load Leg Angle | Number of participants who set the load leg to the correct angle, including those who needed prompted to use it. | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 study visit, an average of 30 minutes |
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| 0 |
| 50 |
| 0 |
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| 50 |
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| D013676 |
| Technology, Industry, and Agriculture |