Clinical trial NCT05252299: Infant Car Seat Use
Official title: Feasibility and Acceptability of Rolling Refresher Training for Caregivers on Proper Infant Car Seat Use, Version 4.0, July 12, 2018
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Car Seat Safety Training
Keywords: car seat
Pediatric
safety
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Statistical power is not the goal for this pilot study; rather, we wish to obtain estimates of feasibility as a basis for a future randomized controlled trial. As such, we plan to enroll 30 caregivers in each group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Motor vehicle crashes (MVCs) kill more children and young adults than any other single cause in the United States. Proper use of the child safety seat (car seat, or CSS) reduces the risk of death by 71% in infants, and to toddlers by 54%. While the rate of CSS use has increased across all age groups over the last few decades,91% of observed CSSs demonstrate serious installation errors in the newborn population and 62% in all ages.In addition, non-white children have higher rates of misuse and non-use of CSS compared to white children, and the proportion of unrestrained deaths from MVCs in black and Hispanic children is almost twice that of white children (45% vs 26%). Certified child passenger safety technicians (CPST) provide interactive training to families on how to install and correct errors in their child's CSS. The use of CPSTs through "car seat checks" has been successful in increasing participants' (caregivers) skills, knowledge, and confidence, and reducing errors in CSS use.

Detailed description: Motor vehicle crashes (MVCs) kill more children and young adults than any other single cause in the United States. Proper use of the child safety seat (car seat, or CSS) reduces the risk of death by 71% in infants, and to toddlers by 54%. While the rate of CSS use has increased across all age groups over the last few decades,91% of observed CSSs demonstrate serious installation errors in the newborn population and 62% in all ages.In addition, non-white children have higher rates of misuse and non-use of CSS compared to white children, and the proportion of unrestrained deaths from MVCs in black and Hispanic children is almost twice that of white children (45% vs 26%). Certified child passenger safety technicians (CPST) provide interactive training to families on how to install and correct errors in their child's CSS. The use of CPSTs through "car seat checks" has been successful in increasing caregivers' skills, knowledge, and confidence, and reducing errors in CSS use. However, car seat checks are disproportionately accessed by parents who are white, middle or upper class, and college-educated and thereby are not serving as an effective solution for the racial disparities in CSS misuse. In addition, there are challenges: A one-time interaction with a CPST does not lead to sustained success in correction of CSS errors, with 40% of families demonstrating serious errors in CSS use just 4 months after training; and with only about 33,000 CPSTs nationally for over 40 million CSS-eligible children, the resources required for in-person CPSTs to be easily accessible to all families with CSS eligible children make broad dissemination difficult. Remote quarterly CSS instruction via telemedicine can perhaps alleviate these problems and make CPSTs more easily accessible to all, including low-income and non-white families. Preliminary research reveals that the use of telemedicine to provide remote CSS installation instruction via audio and visual input by a CPST is better than using the written instruction manual alone, and leads to increased parental self-efficacy. In addition, telemedicine has been successfully used to address racial disparities in the treatment of heart failure, acute stroke, and other disease processes.

This study will use telemedicine to facilitate an innovative use of "rolling refresher" training (RRT), a technique used in medical education to provide hands-on interactive training at regular intervals with the goal of improving psychomotor skills required for high stakes procedures such as cardiopulmonary resuscitation. This study seeks to interrogate the investigator's hypothesis that providing instruction on CSS use to participants via telemedicine every 3 months during the first year of an infant's life is feasible and acceptable to participants. The investigators plan to do this through three specific aims: (1) Identify perceived barriers and motivators of participants to receipt of instruction on proper CSS use, and tailor intervention details based on their input; (2) Measure the feasibility and acceptability of providing participant-centered RRT on CSS use in a diverse population, including non-white populations at risk for disparities; and (3) Measure the preliminary effectiveness of RRT on serious errors in CSS use, and the disparities in error rates. Results will be used to develop a randomized controlled trial to evaluate the impact of using telemedicine to provide RRT on CSS use and impact on the known racial disparities in CSS use.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking parents and/or caregivers of full-term newborns born at the George Washington University (GWU) Hospital, and
* Mother/child are discharged from GWU Hospital together
* Have regular access to a car, and
* Have access to a smartphone or tablet

Exclusion Criteria:

* Parents/caregivers who do not speak English or Spanish
* Mother and newborn are not discharged together
* Infant is premature (\< 35 weeks gestational age) Parents/caregivers do not have access to smartphone or tablet
* Parents/caregivers do not have regular access to a car

Primary outcomes:
measure: Feasibility and acceptability of the car seat enhanced usual care and the intervention group
timeFrame: 1 year
measure: The proportion of caregivers who made critical CSS use errors during CSS
timeFrame: 1 year
measure: The reduction in total number of CSS use errors
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: James Chamberlain, MD
role: PRINCIPAL_INVESTIGATOR
References: