Improving Child Restraint Installation

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03508843
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 36.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Car Seat Installation	Behavioral: interactive virtual presence	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Improving Child Restraint Installation in Rural America Through Interactive Virtual Presence
• Actual Study Start Date: Jun 9, 2018
• Actual Primary Completion Date: Oct 13, 2018
• Actual Study Completion Date: Oct 13, 2018

Arms and Interventions

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	Behavioral: interactive virtual presence; installing the car seat with advice via interactive virtual presence

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Accurately Select a Safe Child Restraint [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

2. Number of Participants Who Install the Child Restraint Accurately Into the Vehicle [immediately (< 5 minutes) after the car seat is installed]

   accurate installation of the child restraint into the vehicle

3. Number of Participants Who Properly Position the Child Restraint in the Vehicle [immediately (< 5 minutes) after the car seat is installed]

   proper positioning of the child restraint in the vehicle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Youth Safety Lab, University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: David C Schwebel, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 23, 2019

More Information

Publications

None provided.

• Responsible Party: David Schwebel, University Professor & Associate Dean, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03508843
• Other Study ID Numbers: 300001220
• First Posted: Apr 26, 2018
• Last Update Posted: Oct 18, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
Period Title: Overall Study
STARTED	150
COMPLETED	147
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
Overall Participants	147
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (7.7)
Sex: Female, Male (Count of Participants)
Female	82 55.8%
Male	65 44.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 6.8%
Not Hispanic or Latino	137 93.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	18 12.2%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	111 75.5%
More than one race	0 0%
Unknown or Not Reported	18 12.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Accurately Select a Safe Child Restraint
Description	accurate selection of a safe child restraint that was proper for the child's age and size
Time Frame	immediately (< 5 minutes) after the car seat is installed

Outcome Measure Data

Analysis Population Description

comparison to baseline

Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
Measure Participants	142
post-intervention	131 89.1%
baseline	121 82.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interactive Virtual Presence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	McNemar
	Comments

2. Primary Outcome

Title	Number of Participants Who Install the Child Restraint Accurately Into the Vehicle
Description	accurate installation of the child restraint into the vehicle
Time Frame	immediately (< 5 minutes) after the car seat is installed

Outcome Measure Data

Analysis Population Description

comparison to baseline

Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
Measure Participants	120
post-intervention	45 30.6%
baseline	18 12.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interactive Virtual Presence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	McNemar
	Comments

3. Primary Outcome

Title	Number of Participants Who Properly Position the Child Restraint in the Vehicle
Description	proper positioning of the child restraint in the vehicle
Time Frame	immediately (< 5 minutes) after the car seat is installed

Outcome Measure Data

Analysis Population Description

comparison to baseline

Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
Measure Participants	77
post-intervention	51 34.7%
baseline	33 22.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interactive Virtual Presence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	McNemar
	Comments

Adverse Events

Time Frame	45 minutes, from baseline through post-intervention assessment
Arm/Group Title	Interactive Virtual Presence
Arm/Group Description	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
All Cause Mortality
	Interactive Virtual Presence
	Affected / at Risk (%)	# Events
Total	0/150 (0%)
Serious Adverse Events
	Interactive Virtual Presence
	Affected / at Risk (%)	# Events
Total	0/150 (0%)
Other (Not Including Serious) Adverse Events
	Interactive Virtual Presence
	Affected / at Risk (%)	# Events
Total	0/150 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.