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| Name | Class |
|---|---|
| Safe Kids Worldwide | UNKNOWN |
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Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized.
The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) to remotely assist parents to install child restraints correctly into their vehicles. Building from small pilot studies on the topic, the investigators will conduct a randomized non-inferiority trial to evaluate whether parents who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite.
The investigators will recruit 1476 parents at 7 locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.
Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats (also called "child restraints") reduce risk of serious injury and death to infants and young children roughly threefold. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians, many affiliated with Safe Kids Worldwide, work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized due to barriers in access, scheduling complications, and resources to staff the car seat checks sufficiently to meet demand.
The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) - joint and simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli - to remotely assist parents to install child restraints correctly into their vehicles. If effective, this technology could supplement or replace car seat checks, significantly reduce the number of errors made in car seat installations nationwide, and revolutionize how government, industry, and non-profit agencies help parents install restraints.
Building from small pilot studies on the topic, the investigators propose a large randomized non-inferiority trial to evaluate whether parents, including especially underserved parents in rural areas and/or of underrepresented racial or ethnic minority background, who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite. Non-inferiority trials are a type of randomized trial whereby a novel treatment (in this case, interactive virtual presence to install child restraints) is compared to an existing treatment known to be effective (in this case, live one-on-one installation of restraints) to demonstrate the novel treatment does not perform inferiorly to the existing treatment known to be effective.
To accomplish the study goals, the investigators will recruit 1476 parents at 7 Safe Kids locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive virtual presence | Experimental | Participants will engage remotely with a certified child restraint technician via interactive virtual presence. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed, with the exception that the interaction will occur remotely via interactive virtual presence. |
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| Live technician | Active Comparator | Participants will engage live with a certified child restraint technician. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interactive virtual presence | Behavioral | parents will install car seat through remote guidance via interactive virtual presence |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Inspection Points Correctly Installed From Pre Installation to Post Installation | Percentage of inspection points in car seat installation that are correctly installed, as assessed using objective scoring scheme | baseline to post intervention about an hour later |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Youth Safety Lab, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
Data will be shared with qualified researchers upon written request.
Upon written request and after primary results have been accepted for publication. We will share data until they are destroyed, which is when all foreseeable use of the data has expired.
Contact the PI in writing
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| ID | Title | Description |
|---|---|---|
| FG000 | Interactive Virtual Presence | Participants will engage remotely with a certified child restraint technician via interactive virtual presence. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed, with the exception that the interaction will occur remotely via interactive virtual presence. interactive virtual presence: parents will install car seat through remote guidance via interactive virtual presence |
| FG001 | Live Technician | Participants will engage live with a certified child restraint technician. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed. live technician: parents will install car seat through guidance from a live certified technician who is present |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Interactive Virtual Presence | Participants will engage remotely with a certified child restraint technician via interactive virtual presence. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed, with the exception that the interaction will occur remotely via interactive virtual presence. interactive virtual presence: parents will install car seat through remote guidance via interactive virtual presence |
| 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, Continuous | Mean |
| 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 | Percentage of Inspection Points Correctly Installed From Pre Installation to Post Installation | Percentage of inspection points in car seat installation that are correctly installed, as assessed using objective scoring scheme | Posted | Mean | Standard Deviation | percentage of inspection points | baseline to post intervention about an hour later |
|
4 months
Does not differ from clinicaltrials.gov definitions.
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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 | Interactive Virtual Presence | Participants will engage remotely with a certified child restraint technician via interactive virtual presence. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed, with the exception that the interaction will occur remotely via interactive virtual presence. interactive virtual presence: parents will install car seat through remote guidance via interactive virtual presence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Schwebel | University of Alabama at Birmingham | 205-934-8745 | schwebel@uab.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 | Jun 10, 2024 | Jun 10, 2024 | Prot_SAP_000.pdf |
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randomized non-inferiority trial
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| live technician | Behavioral | parents will install car seat through guidance from a live certified technician who is present |
|
| BG001 | Live Technician | Participants will engage live with a certified child restraint technician. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed. live technician: parents will install car seat through guidance from a live certified technician who is present |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants who drive a vehicle with young children | Count of Participants | Participants |
|
| OG001 |
| Live Technician |
Participants will engage live with a certified child restraint technician. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed. live technician: parents will install car seat through guidance from a live certified technician who is present |
|
|
|
| 0 |
| 699 |
| 0 |
| 699 |
| 0 |
| 699 |
| EG001 | Live Technician | Participants will engage live with a certified child restraint technician. They will work together to help the participant install his or her child restraint properly into his or her vehicle. Standard Safe Kids Worldwide protocols will be followed. live technician: parents will install car seat through guidance from a live certified technician who is present | 0 | 799 | 0 | 799 | 0 | 799 |
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