- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508843
Improving Child Restraint Installation
Improving Child Restraint Installation in Rural America Through Interactive Virtual Presence
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB Youth Safety Lab, University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- communicate in English
- drive a vehicle with one or more car seats present
- willing to install a car seat into the vehicle
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: interactive virtual presence
install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence
|
installing the car seat with advice via interactive virtual presence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Accurately Select a Safe Child Restraint
Time Frame: immediately (< 5 minutes) after the car seat is installed
|
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
Time Frame: immediately (< 5 minutes) after the car seat is installed
|
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
Time Frame: immediately (< 5 minutes) after the car seat is installed
|
proper positioning of the child restraint in the vehicle
|
immediately (< 5 minutes) after the car seat is installed
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 300001220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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