Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations

• ClinicalTrials.gov Identifier: NCT03877744
• Recruitment Status: Recruiting
• First Posted: March 18, 2019
• Last Update Posted: February 4, 2022
• Sponsor: University of Alabama at Birmingham
• Collaborator: Safe Kids Worldwide
• Information provided by (Responsible Party): David Schwebel, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Car Seat Installation	Behavioral: interactive virtual presence; Behavioral: live technician	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1476 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: randomized non-inferiority trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
• Actual Study Start Date: January 23, 2020
• Estimated Primary Completion Date: August 15, 2024
• Estimated Study Completion Date: August 15, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: interactive virtual presence; parents will install car seat through remote guidance via interactive virtual presence
Active Comparator: 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.	Behavioral: live technician; parents will install car seat through guidance from a live certified technician who is present

Outcome Measures

Primary Outcome Measures :

1. Change in number of inspection points correctly installed from pre installation to post installation [ Time Frame: baseline to post intervention about an hour later ]
   Number of inspection points in car seat installation that are correctly installed, as assessed using objective scoring scheme
2. Whether the restraint is installed correctly vs. not [ Time Frame: immediately post intervention ]
   Dichotomous measure of completely correct restraint installation versus not completely correct, as assessed using objective scoring scheme

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Alabama

UAB Youth Safety Lab, University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Anna Johnston, MA 205-934-4068 safetylab@uab.edu

Contact: David C Schwebel, PhD 205-934-8745 schwebel@uab.edu

Principal Investigator: David Schwebel, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

Safe Kids Worldwide

More Information

• Responsible Party: David Schwebel, University Professor & Associate Dean, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03877744
• Other Study ID Numbers: R01HD099131 ( U.S. NIH Grant/Contract )
• First Posted: March 18, 2019
• Last Update Posted: February 4, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be shared with qualified researchers upon written request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: 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.
• Access Criteria: Contact the PI in writing

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No