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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tiny Cargo, Big Deal! An Adaptive ED-Based eHealth Intervention to Promote Correct and Consistent Size-Appropriate Child Passenger Safety Behaviors and Reduce Disparities

Conditions
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Accident, Traffic

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced Usual Care<br>Participants will be randomized after completion of the baseline survey and receive a basic information sheet (print or electronic). Months 1-12: Participants receive monthly, unscheduled requests to submit photographs as their child usually travels. Feedback is provided for critical errors and misuse. Follow-up occurs at 6 months. Outcomes are assessed at 12 months. | |
| Experimental: Basic Intervention<br>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. | Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention<br>* 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.<br>|
| Experimental: Enhanced Intervention<br>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. | Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention<br>* 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.<br>Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child restraint systems (car seats and booster seats), seat belts, Motivational Interviewing