Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors (NCT04238247) | Clinical Trial Compass
CompletedNot Applicable
Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
United States513 participantsStarted 2020-02-05
Plain-language 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.
Who can participate
Age range
6 Months – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
Timeframe: 6-Month Assessment
2
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months
Timeframe: 12-Month Assessment
Trial details
NCT IDNCT04238247
SponsorAnn & Robert H Lurie Children's Hospital of Chicago