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Completed

NCT Number: NCT04238247

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

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.

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Key information

Conditions

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention

Behavioral

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

Behavioral

The Enhanced TCBD/ABCB Intervention includes a second motivational interviewing session. Basic Intervention text messages continue with an additional 1-2 tailored text messages per month.

Primary outcomes

  1. Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months

    Time frame: 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

  2. Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months

    Time frame: 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

Other outcomes

  1. CPaSS Trajectories

    Time frame: 12-Month Assessment

    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.

  2. Child Passenger Safety Score (CPaSS)

    Time frame: 12-Month Assessment

    At the 12-month follow-up assessment, we obtained 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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • University of Michigan

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2020
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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