N/A
N=474
Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
Accident, Traffic
Bottom Line
View on ClinicalTrials.gov: NCT04238247 ↗Enrolled (actual)
474
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months — 38; 131 Participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention (Behavioral); Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months |
38; 131 | 0.006 sig |
| PRIMARY Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months |
43; 59; 40; 39 | 0.671 |
Summary
This study involves an emergency department (ED)-based intervention utilizing Motivational Interviewing (MI) techniques and patient-centered eHealth materials (e.g., a tailored, mobile-friendly website and text messages) to promote the correct and consistent use of size-appropriate child passenger restraints (car seats, booster seats, and seat belts). This study is designed as an adaptive randomized controlled trial, recruiting English and Spanish speaking caregivers of children 6 months to 10 years old.
Eligibility Criteria
Child refers to the child of the caregiver (parent/legal guardian) who is being evaluated for recruitment and participation in the study.
Inclusion Criteria
- Child is age 6 months to 10 years old at screening
- Child is seeking care in the Emergency Department (ED) for a non-critical injury or illness
- Child sought emergency or urgent care at a study site
- Caregiver/parent is the legal guardian of the child who is receiving or received emergency or urgent care at a study site
- Child is less than 55 inches tall
- Caregiver speaks English or Spanish
- Caregiver is 18 years old or older
- Caregiver screening survey responses indicate: child travels at least once per week in a passenger vehicle
- AND child is able to use a standard car seat or booster seat (child restraint system) but is not using an age and size-appropriate child restraint system OR travels unrestrained OR sits in the vehicle front seat OR caregiver plans to stop using the age and size-appropriate restraint in the next 6 months (planned premature transition)
Exclusion Criteria
- Caregiver does not understand/speak English or Spanish
- Child is seeking/sought care for child abuse/neglect
- Child is seeking/sought care that requires intensive psychosocial services
- Child is seeking/sought treatment for a motor vehicle related injury
- Child is too tall for study (height = >55 inches tall)
- Caregiver is under 18 years of age
- Caregiver does not have a smart phone
- Caregiver lives outside of the state of Illinois
- Caregiver is already enrolled in this study
- Caregiver completed the screen to determine eligibility for study in the past 6 months
Exclusions applied only to in-person recruitment in the ED:
- Child is seeking treatment for a new long-term diagnosis
- Child has anticipated need for admission
- Child is seeking care for a critical illness or injury
Data sourced from ClinicalTrials.gov (NCT04238247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.