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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD085660 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Minnesota HealthSolutions | INDUSTRY |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The overall objective of this study is to evaluate the efficacy of a tensioning progress indicator light to achieve proper harness tensioning in child safety seats.
The primary objective of the study is to determine whether a prototype convertible child safety seat with visual indication of successful tensioning technology reduces the amount of harness slack compared with a standard safety seat. The secondary objective of the study is to assess caregivers' perceptions of the quality, design, and ease of use of the prototype child safety seat tensioning progress indicator lights. Participants will be parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age. Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to harness their child into two versions of a convertible child safety seat, twice in each car seat. The intervention seat will be equipped with the technology that gives visual indication of successful harness tensioning. Participants will be observed, assessed, and asked a series of survey questions after each harnessing period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harnessing Sequence A | Experimental | Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control. |
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| Harnessing Sequence B | Experimental | Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype. |
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| Harnessing Sequence C | Experimental | Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype. |
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| Harnessing Sequence D | Experimental | Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype child safety seat with tension indicator lights | Device | The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in harness tension | After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative "pinch" test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared. | Up to 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Participant perceptions of usability of the tension progress indicator light technology: survey | Participant perceptions of the usability of the technology will be collected and the control and prototype harnessing systems will be compared. Participants will be asked to complete a post-intervention survey that contains 4 items pertaining to the usability of the technology through Likert scales (range from Very difficult to Very easy). There is no overall score for these survey items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Curry, PhD, MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Nick Rydberg | Minnesota HealthSolutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia Roberts Center for Pediatric Research | Philadelphia | Pennsylvania | 19146 | United States |
Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.
IRB approval, data use agreement
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2021 | Jan 13, 2022 | ICF_001.pdf |
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This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.
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The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.
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| Control child safety seat | Device | The control child safety seat is a convertible rear-facing seat without tension indicator lights. |
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| 30 minutes |