A Phase 2 interventional study of CCS System- Prototype and CCS System- Control in Child Safety Seat Harness Tension, sponsored by Minnesota HealthSolutions. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Minnesota HealthSolutions · Phase 2, Interventional, and Other
The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.
The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.
Minnesota HealthSolutions is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.
Device: CCS System- Prototype
Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.
Device: CCS System- Control
Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
Number of Participants With Installation Errors
For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).
Time frame: Once during the only study visit: up to 30 mins
| Milestone | Intervention | Control |
|---|---|---|
| Started | 46 | 46 |
| Completed | 46 | 46 |
| Not completed | 0 | 0 |
For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).
| Participants | Intervention - Scenario A | Control - Scenario A | Intervention - Scenario B | Control - Scenario B | Intervention - Scenario C | Control - Scenario C |
|---|---|---|---|---|---|---|
| Number of Participants With Installation Errors | 21 | 41 | 17 | 32 | 18 | 33 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Control | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Intervention | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 46 | 92 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Median | 37 (31 to 59) | 36 (24 to 44) | 36 (24 to 59) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 38 | 39 | 77 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 44 | 41 | 85 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 11 | 19 |
| White | 33 | 23 | 56 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 2 | 5 | 7 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 46 | 46 | 92 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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