Clinical trial NCT03877744: Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
Official title: Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Car Seat Installation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Safe Kids Worldwide
First posted: 2019-03-18
Enrollment: 1498
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized non-inferiority trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* own a vehicle and have a child who rides in that vehicle using a child restraint fastened with a harness.

Exclusion Criteria:

* not physically capable of installing a child restraint into a vehicle, which may exclude individuals with various disabilities.
* not able to communicate orally in English or Spanish, although significant demand for training in other languages may alter this exclusion criteria in the future

Primary outcomes:
measure: Percentage of Inspection Points Correctly Installed From Pre Installation to Post Installation
timeFrame: baseline to post intervention about an hour later
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Youth Safety Lab, University of Alabama at Birmingham
state: Alabama
Study officials:
References: