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

NCT04238247 | Completed Results

• 1 other identifier: HD092594
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

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.

Conditions

Accident, Traffic

Keywords

child restraint systems (car seats and booster seats); seat belts; Motivational Interviewing

Outcome Measures

Primary Outcomes (2)

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

  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

  6-Month Assessment

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

  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

  12-Month Assessment

Other Outcomes (2)

• CPaSS Trajectories

  12-Month Assessment

• Child Passenger Safety Score (CPaSS)

  12-Month Assessment

Study Arms (3)

Enhanced Usual Care

NO INTERVENTION

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.

Basic Intervention

EXPERIMENTAL

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

Enhanced Intervention

EXPERIMENTAL

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; Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention

Interventions

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.

Basic Intervention; Enhanced Intervention

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.

Enhanced Intervention

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• University of Michigan: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Macy ML, Pollock B, Kendi S, Goldstick J, Cieslak K, Carter PM, Resnicow K. Multimodal Intervention and Child Passenger Safety Guideline Adherence in Young Children: A Sequential, Multiple-Assignment, Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2533912. doi: 10.1001/jamanetworkopen.2025.33912.

  PMID: 41021229 DERIVED

• 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.

  PMID: 35918028 DERIVED

Limitations and Caveats

Recruitment was negatively impacted by the coronavirus disease 19 (COVID-19) pandemic and we were unable to achieve our target sample size. The Child Passenger Safety Score (CPaSS) Tool requires additional calibration to assure greater reliability before we are able to report outcomes that are dependent upon this score.

Results Point of Contact

• Title: Dr. Michelle Macy
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

mmacy@luriechildrens.org

312-227-6676

Study Officials

• Michelle Macy, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded study where a portion of the study will include blinding of study team members who are assessing outcomes. The blinding will not include the participants. The portion of the study that includes blinding is the review of the monthly photo submissions. Participants send us via text message over the course of 12 months. Each photograph is reviewed and scored by two team members. The first reviewer is blinded to study condition and saves the photographs with the child's face blurred. The second reviewer scores the photographs after the child's face has been blurred to verify findings of the first reviewer. The second reviewer is then unblinded to send feedback to the caregiver appropriate for their study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: February 5, 2020
• Primary Completion: September 29, 2023
• Study Completion: October 31, 2023
• Last Updated: April 15, 2026
• Results First Posted: May 14, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)