Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors

Accident, Traffic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04238247
• Other study ID #: HD092594
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 475
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Accident, Traffic

Intervention

Behavioral:
• Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention
A bilingual emergency department (ED)-based precision prevention intervention grounded in Self-Determination Theory. The Basic TCBD/ABCB intervention integrates one personalized counseling session based on principles of motivational interviewing (MI) and eHealth components including a tailored mobile-friendly educational website and short message service (SMS) text message communications with the goal of improving child passenger safety. Participants receive monthly text message requests to submit photographs depicting the child as they usually travel. Feedback is provided via text message to correct any observed errors or misuse. Tailored informational and motivational text messages are sent twice each month.
• Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention
The Enhanced TBDC/ABCB Intervention includes a second motivational interviewing session. Basic Intervention text messages continue with an additional 1-2 tailored text messages per month.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Passenger Safety Guideline Adherence	At the 12-month follow-up assessment, conducted remotely or in-person, we will reassess the child's current passenger restraint use and safety behaviors. For this dichotomous outcome, caregivers will be considered guideline adherent if their child is using the recommended child restraint system for their weight and height AND is seated in the vehicle back seat.	12 month follow-up
Primary	Child Passenger Safety Score (CPaSS)	At the 12-month follow-up assessment, we will obtain photographs from the caregiver remotely or by research staff in-person. Photographs will be reviewed using the Child Passenger Safety Score checklist. Points will be deducted from a perfect score of 100 based on observe errors and misuse.	12 month follow-up
Secondary	CPaSS Trajectories	We will use latent growth curve models to identify characteristic trajectories for Child Passenger Safety Scores based on photographs of children as they typically travel obtained at baseline, months 1-4, 6-month assessment, months 8-11, and 12-month assessment.	12 month follow-up