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The investigators will conduct a pre-post trial with 150 parents in rural South Central Montana. The study will recruit families to cooperating community locations (e.g., churches, public libraries) to participate in research evaluating the efficacy of parents installing restraints with guidance from a remotely-located technician using interactive virtual presence. Following informed consent procedures, parents will complete a brief survey on behaviors, attitudes, and perceptions about child safety and restraints while an on-site technician evaluates baseline safety of the restraint. Parents will then engage remotely using their personal smartphone with an off-site certified car seat technician, obtaining advice to install the child restraint properly via the HelpLightning interactive virtual presence app. Following the remote interaction, the on-site technician will again inspect the restraint using the validated checklist (and correct any errors prior to the participant leaving). The overall goal is to demonstrate installation of child restraints can be effectively accomplished to rural populations using interactive virtual presence. The study has 2 specific aims:
Specific Aim 1. Demonstrate technological and behavioral efficacy of providing instructions on child restraint installation remotely to rural populations. Demonstrate >95% of interactions proceed without technical problems, without reports of communication difficulty on either end of the exchange (the parent or the technician), and without interruption.
Specific Aim 2. Identify accuracy of child restraint installation by parents using instructions provided by a remotely-located certified technician via interactive virtual presence. Demonstrate installation in this manner achieves ≥90% accuracy across all aspects of child restraint installation. Demonstrate installation in this manner significantly reduces restraint installation errors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interactive virtual presence | Experimental | install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interactive virtual presence | Behavioral | installing the car seat with advice via interactive virtual presence |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Accurately Select a Safe Child Restraint | accurate selection of a safe child restraint that was proper for the child's age and size | immediately (< 5 minutes) after the car seat is installed |
| Number of Participants Who Install the Child Restraint Accurately Into the Vehicle | accurate installation of the child restraint into the vehicle | immediately (< 5 minutes) after the car seat is installed |
| Number of Participants Who Properly Position the Child Restraint in the Vehicle | proper positioning of the child restraint in the vehicle | immediately (< 5 minutes) after the car seat is installed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Schwebel, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Youth Safety Lab, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interactive Virtual Presence | install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence interactive virtual presence: installing the car seat with advice via interactive virtual presence |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adult caregivers of young children from southeast Montana who drove a vehicle with a child restraint in it. Participants for whom <70% of items in a category could be coded at baseline or post-intervention were excluded from those analyses; common exclusions were baseline situations with uninstalled restraint or children not present.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interactive Virtual Presence | install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence interactive virtual presence: installing the car seat with advice via interactive virtual presence |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants Who Accurately Select a Safe Child Restraint | accurate selection of a safe child restraint that was proper for the child's age and size | comparison to baseline | Posted | Count of Participants | Participants | immediately (< 5 minutes) after the car seat is installed |
|
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45 minutes, from baseline through post-intervention assessment
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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 | install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence interactive virtual presence: installing the car seat with advice via interactive virtual presence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Schwebel | University of Alabama at Birmingham | 1-205-934-8745 | 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 | Aug 23, 2019 | Aug 23, 2019 | Prot_SAP_000.pdf |
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| years |
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| 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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| Participants |
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| Primary | Number of Participants Who Install the Child Restraint Accurately Into the Vehicle | accurate installation of the child restraint into the vehicle | comparison to baseline | Posted | Count of Participants | Participants | immediately (< 5 minutes) after the car seat is installed |
|
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| Primary | Number of Participants Who Properly Position the Child Restraint in the Vehicle | proper positioning of the child restraint in the vehicle | comparison to baseline | Posted | Count of Participants | Participants | immediately (< 5 minutes) after the car seat is installed |
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| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
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