NCT05252299|CompletedDMC
Infant Car Seat Use
Feasibility and Acceptability of Rolling Refresher Training for Caregivers on Proper Infant Car Seat Use, Version 4.0, July 12, 2018
Loading search results
Feasibility and Acceptability of Rolling Refresher Training for Caregivers on Proper Infant Car Seat Use, Version 4.0, July 12, 2018
Sponsor study identifier
interventional
40
1 country
1
Study Start
December 31, 2018
Actual (reported)Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 31, 2018
Actual (reported)December 1, 2021
Actual (reported)December 2, 2021
Actual (reported)December 31, 2021
Actual (reported)February 23, 2022
Actual (reported)Feasibility and acceptability of the car seat enhanced usual care and the intervention group
Both the enhanced usual care and the intervention groups will be provided an initial in-person car seat check prior to discharge from the nursery, which will include documentation and correction of errors and survey completion by participants. Rates of the feasibility outcomes (with 95% confidence intervals (CI's)) will be calculated. This is also measured by the retention of the participants in the year-long intervention.
1 year
The proportion of caregivers who made critical CSS use errors during CSS
Errors will be assessed as a dichotomous variable indicating whether or not any errors were made at each visit using repeated measures log-binomial regression. An interaction term between randomization group and time will be included in the model to estimate differences in slope (i.e. change in proportion of caregivers making errors) between the intervention and control groups over the course of the study. To explore differential effects by race/ethnicity, a three-way interaction term of group x race x time will be used to evaluate whether differences in slope between intervention and control groups differ by race/ethnicity (i.e. whether effects of the intervention are stronger in the non-white population).
1 year
The reduction in total number of CSS use errors
The CSS check will be provided by telemedicine for both the enhanced usual care and intervention groups at 0 and 9 months of age. The CSS check will be provided to the intervention group using telemedicine technology (Help Lightning) at 3, 6, and 9 months of age. Participants in both groups will have CSS use errors recorded with each interaction with a CPST. The intervention group will have errors recorded every 3 months, and the enhanced usual care group will have errors recorded at the 0 and 9 month car seat checks. Proportion of caregivers with critical errors, and total number of errors will be evaluated and compared between the intervention and control groups at the newborn, 12, 18 and, and 24 month points.
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.
They leave the hospital without the additional training and under hospital's normal discharge plan
The use of telemedicine to provide remote CSS installation instruction via audio and visual input by a Certified child passenger safety technician (CPST)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
George Washington Hospital
Washington D.C., District of Columbia, 20010, United States
James Chamberlain, MD
Children's National Research Institute
40 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2021
First Posted
February 23, 2022
Study Start
1 year
Contact the study team to confirm eligibility.
December 31, 2018
Actual (reported)Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
February 23, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: