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

Not Applicable

Completed

Conditions: Accident, Traffic

Interventions: Behavioral: 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

Registration Number: NCT04238247

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 513

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Intervention	Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention	After completion of their 6 month follow-up, participants re-randomized to Enhanced Intervention receive Basic Intervention components plus an additional counseling session (Months 7/8) and additional tailored text messages (Months 7-12). Months 7-12: Participants continue to receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Outcomes are assessed at 12 months.
Enhanced Intervention	Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention	After completion of their 6 month follow-up, participants re-randomized to Enhanced Intervention receive Basic Intervention components plus an additional counseling session (Months 7/8) and additional tailored text messages (Months 7-12). Months 7-12: Participants continue to receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Outcomes are assessed at 12 months.
Basic Intervention	Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention	Participants will be randomized after completion of the baseline survey and receive a basic information sheet (print or electronic). Participants receive a counseling session, access to the study's tailored, educational website, and tailored informational and motivational text messages. Months 1-6: Participants receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Follow-up occurs at 6 months. After completion of their 6 month follow-up, participants in the Basic Intervention group will be eligible for re-randomization if they continue to not adhere to guidelines or plan a premature transition. Months 7-12: Participants continue to receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided. Outcomes are assessed at 12 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months	6-Month Assessment	At the 6-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use and safety behaviors. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months	12-Month Assessment	At the 12-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use. For this dichotomous outcome, caregivers were considered guideline adherent if: 1) the caregiver-reported usual restraint was age and size APPROPRIATE;\* and 2) the child was reported to NEVER travel UNRESTRAINED; and 3) ALWAYS seated in the vehicle BACK SEAT. \*weight, height, and age parameters: Rear-facing appropriate if child \<40 pounds; \<40 inches; up to age 3 Forward-facing appropriate if child \>=22 pounds, \<65 pounds; \>=28 inches, \<49 inches, at least 3 years old Booster appropriate if child \>=40 pounds, \<100 pounds; High Back \>=38 inches/Backless \>=43 inches; \<57 inches, at least 5 years old Seat Belt alone appropriate if child \>=100 pounds; at least 57 inches