Infant Car Seat Use

NCT ID: NCT05252299

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Pediatric Car Seat Safety Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Refresher Training Group

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 our hypothesis that providing instruction on CSS use to caretakers via telemedicine every 3 months during the first year of an infant's life is feasible and acceptable to caregivers.

Group Type: EXPERIMENTAL

Rolling Fresher Group

Intervention Type: OTHER

The use of telemedicine to provide remote CSS installation instruction via audio and visual input by a Certified child passenger safety technician (CPST)

Traditional Group

They leave the hospital without the additional training and under hospital's normal discharge plan

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rolling Fresher Group

The use of telemedicine to provide remote CSS installation instruction via audio and visual input by a Certified child passenger safety technician (CPST)

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

James Chamberlain

Emergency Medicine Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Chamberlain, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

George Washington Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

00013738

Identifier Type: -

Identifier Source: org_study_id