Child Safety Seat Harness Tension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECCS System- Prototype
Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)
DEVICECCS System- Control
The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).
Sponsors
Children's Hospital of Philadelphia
University of Alabama at Birmingham
Minnesota HealthSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned to the intervention group or control group upon arrival at the study visit. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.
Intervention model description
This study is a randomized control trial with 2 arms (intervention and control). The intervention group will participate in a series of three safety seat misuse scenarios with the CCS system enabled, and participants in the control group will participate in the same series of three safety seat misuse scenarios without the CCS system. Misuse scenarios include insecure attachment of the seat to the vehicle, incorrect harness straps, and improper orientation of the safety seat. In each scenario, participants will be asked to identify and correct each error. Each participant will be randomly assigned to either the control or intervention group. Each participant will receive the same scenarios in the same order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or Females ages 18-75 years * Has harnessed/fastened a child into a car seat in the last five (5) years * Has a valid driver's license
Exclusion criteria
* Non-fluency in written and/or spoken English * Participant cannot install a safety seat due to a physical or health limitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Installation Errors | Once during the only study visit: up to 30 mins | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.
CCS System- Prototype: Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback) | 46 |
| Control Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.
CCS System- Control: The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback). | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 46 Participants | 92 Participants |
| Age, Continuous | 37 years | 36 years | 36 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 41 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 33 Participants | 23 Participants | 56 Participants |
| Region of Enrollment United States | 46 participants | 46 participants | 92 participants |
| Sex: Female, Male Female | 38 Participants | 39 Participants | 77 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
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
Population: Participants in the intervention group were given a study phone and asked to use the CCS smartphone app to complete the scenarios, while the control group was given only the paper manual that came with the safety seat. The misuse scenarios included A) a full safety seat installation with the convertible seat beginning on the floor, B) loose harness straps, and C) loose attachment to the vehicle seat at the base.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Scenario A | Number of Participants With Installation Errors | 21 Participants |
| Control - Scenario A | Number of Participants With Installation Errors | 41 Participants |
| Intervention - Scenario B | Number of Participants With Installation Errors | 17 Participants |
| Control - Scenario B | Number of Participants With Installation Errors | 32 Participants |
| Intervention - Scenario C | Number of Participants With Installation Errors | 18 Participants |
| Control - Scenario C | Number of Participants With Installation Errors | 33 Participants |
p-value: <0.001Chi-squared
p-value: <0.01Chi-squared
p-value: <0.01Chi-squared