Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention for Car Accidents
Study Summary
This trial is testing whether an intervention using motivational interviewing and patient-centered eHealth materials can increase the use of proper child restraints in English and Spanish speaking caregivers of children 6 months to 10 years old.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 12 month follow-up
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Group 1: Control Group
1 of 4
Enhanced Usual Care
1 of 4
Enhanced Intervention
1 of 4
Basic Intervention
1 of 4
Active Control
Experimental Treatment
475 Total Participants · 4 Treatment Groups
Primary Treatment: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 10 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Macy, Michelle L., Patrick Carter, Sadiqa Kendi, Bethany Pollock, Liliana San Miguel, Jason Goldstick, and Ken Resnicow. 2022. ““tiny Cargo, Big Deal! Abróchame Bien, Cuídame Bien”, an Emergency Department-based Intervention to Promote Child Passenger Safety: Protocol for an Adaptive Randomized Trial Among Caregivers of 6-month Through 10-year-old Children”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106863.
- Macy, Michelle L., Patrick Carter, Sadiqa Kendi, Bethany Pollock, Liliana San Miguel, Jason Goldstick, and Ken Resnicow. 2022. ““tiny Cargo, Big Deal! Abróchame Bien, Cuídame Bien”, an Emergency Department-based Intervention to Promote Child Passenger Safety: Protocol for an Adaptive Randomized Trial Among Caregivers of 6-month Through 10-year-old Children”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106863.
- Macy ML, Carter P, Kendi S, Pollock B, San Miguel L, Goldstick J, Resnicow K. "Tiny Cargo, Big Deal! Abróchame Bien, Cuídame Bien", an emergency department-based intervention to promote child passenger safety: Protocol for an adaptive randomized trial among caregivers of 6-month through 10-year-old children. Contemp Clin Trials. 2022 Sep;120:106863. doi: 10.1016/j.cct.2022.106863. Epub 2022 Jul 30.
- Macy ML, Carter P, Kendi S, Pollock B, San Miguel L, Goldstick J, Resnicow K. "Tiny Cargo, Big Deal! Abrochame Bien, Cuidame Bien", an emergency department-based intervention to promote child passenger safety: Protocol for an adaptive randomized trial among caregivers of 6-month through 10-year-old children. Contemp Clin Trials. 2022 Sep;120:106863. doi: 10.1016/j.cct.2022.106863. Epub 2022 Jul 30.
- Michelle Macy, MD 2020. "Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04238247.
Frequently Asked Questions
Am I able to register for this clinical trial?
"This experiment is aiming to enroll 900 candidates in the 6 months to 10 years age bracket who have experienced a traffic-related trauma. In order for them to be eligible, they must meet the following criteria: able and willing to use an appropriate car seat or booster seat; travelling unrestrained; occupying a front vehicle position; planning on relinquishing their restraint system within half a year of screening commencement; being no taller than 55 inches tall at time of assessment; having received emergency or urgent care from one of participating sites' EDs, with their legal guardian present when evaluated for recruitment into this trial. Furthermore, said guardian has to be aged 18" - Anonymous Online Contributor
Is this research program currently open to enrolling participants?
"According to the details hosted on clinicaltrials.gov, this medical experiment is presently open for recruitment and was initially posted in January of 2020. The information regarding it has been most recently updated as of October 14th 2021." - Anonymous Online Contributor
What is the total enrollment of participants for this experiment?
"Affirmative. Clinicaltrials.gov has data that suggests this investigation is currently in search of participants; it was initially posted on January 28th 2020 and last edited October 14th 2021. The research requires 900 people to be recruited from a single site." - Anonymous Online Contributor
Does this trial accommodate participants who are beyond the age of twenty?
"This clinical trial allows enrolment from infants of 6 months old to children up to 10 years old, conforming with the set eligibility criteria." - Anonymous Online Contributor