Clinical trial NCT04238247: Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
Official title: Tiny Cargo, Big Deal! An Adaptive ED-Based eHealth Intervention to Promote Correct and Consistent Size-Appropriate Child Passenger Safety Behaviors and Reduce Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accident, Traffic
Keywords: child restraint systems (car seats and booster seats)
seat belts
Motivational Interviewing
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2020-01-23
Enrollment: 513
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the baseline survey, all participants will be randomized into one of two groups: 1) basic intervention or 2) control group. Block randomization (block sizes from four to eight) will be applied to assign participants to intervention or control in a 3:1 ratio. Blocks will be stratified by child passenger safety recommendations for age (\<2 years, rear-facing; 2-4 years, forward-facing; 5+ years, booster seat) and reason for study eligibility (not consistently using the recommended restraint for age and size or planning a premature transition in the coming 6 months).

After 6-month follow-up, participants in the intervention group only who continue suboptimal child passenger safety behaviors will be re-randomized in a 1:1 ratio to basic or enhanced intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Motor vehicle collisions (MVCs) remain the leading cause of unintentional injury deaths among children in the United States (U.S.) and racial/ethnic minority children are disproportionately impacted as suboptimal child passenger safety behaviors are more prevalent in some communities. Existing universal approaches to promote child passenger safety have fallen short of ensuring that all child passengers are correctly using size-appropriate child passenger restraints according to guidelines published by the American Academy of Pediatrics and the National Highway Traffic Safety Administration. Precision prevention programs are urgently needed to improve child passenger safety behaviors among caregivers who have not been responsive to guidelines, laws, and public education campaigns. The proposed research will test the efficacy of Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB), a bilingual emergency department (ED)-based precision prevention intervention grounded in Self-Determination Theory. TCBD/ABCB integrates personalized counseling based on principles of motivational interviewing (MI) and eHealth components including a tailored educational mobile-friendly website "site" and short message service (SMS) communications with the goal of improving child passenger safety. We hypothesize that by providing tailored child passenger safety education and personalized skills for restraint use in a manner that supports autonomous motivation the TCBD/ABCB intervention will be more efficacious than universal approaches (laws/guidelines) for realizing correct use of size-appropriate child passenger restraints.

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

Primary outcomes:
measure: Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months
timeFrame: 6-Month Assessment
measure: Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months
timeFrame: 12-Month Assessment
Secondary outcomes:
Other outcomes:
measure: CPaSS Trajectories
timeFrame: 12-Month Assessment
measure: Child Passenger Safety Score (CPaSS)
timeFrame: 12-Month Assessment
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Michelle Macy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.