NCT04238247

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

Completed NA Results posted Last updated 15 April 2026

What this trial tests

NA trial testing Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention in Accident, Traffic in 513 participants. Completed in 31 October 2023.

Timeline

5 February 2020

Primary endpoint
29 September 2023

31 October 2023

Quick facts

Lead sponsor	Ann & Robert H Lurie Children's Hospital of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	513
Start date	5 February 2020
Primary completion	29 September 2023
Estimated completion	31 October 2023
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Accident, Traffic — all drugs for Accident, Traffic →

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Who can join

Adults 6 Months to 10, any sex, with Accident, Traffic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months Primary · 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 ye

Group	Value	95% CI
Phase 1: Enhanced Usual Care	38
Phase 1: Basic Intervention	131

Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 12 Months Primary · 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 appr

Group	Value	95% CI
Phase 2: Enhanced Usual Care	43
Phase 2: Basic Intervention Guideline Adherent at 6-month Follow-up	59
Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)	40
Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)	39

Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 6 Months Secondary · 6-Month Assessment

At the 6-month follow-up assessment, conducted remotely, we reassessed the child's restraint system use. For this dichotomous outcome, caregivers were considered guideline adherent if the caregiver-reported usual restraint was appropriate for the child's weight, height, and age.\* \*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 in

Group	Value	95% CI
Phase 1: Enhanced Usual Care	52
Phase 1: Basic Intervention	156

Number of Participants With Age- and Size-Appropriate Child Passenger Restraint System Use at 12 Months Secondary · 12-Month Assessment

At the 12-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 the caregiver-reported usual restraint was appropriate for the child's weight, height, and age.\* \*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 in

Group	Value	95% CI
Phase 2: Enhanced Usual Care	59
Phase 2: Basic Intervention Guideline Adherent at 6-month Follow-up	65
Phase 2: Re-Randomized to Basic Intervention	46
Phase 2: Re-Randomized to Enhanced Intervention	49

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, an average of 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1: Enhanced Usual Care (EUC)

Serious: 0/118 (0%)

Deaths: 0/118

Phase 1: Intervention

Serious: 0/274 (0%)

Deaths: 0/274

Phase 2: Enhanced Usual Care (EUC)

Serious: 0/111 (0%)

Deaths: 0/111

Phase 2: Guideline Adherent at 6-month Follow-up

Serious: 0/77 (0%)

Deaths: 0/77

Phase 2: Re-Randomized to Continue Basic Intervention (mHealth)

Serious: 0/84 (0%)

Deaths: 0/84

Phase 2: Re-Randomized to Enhanced Intervention (Booster MI Session)

Serious: 0/87 (0%)

Deaths: 0/87

Other adverse events (1 terms — click to expand)

Reaction	System	Phase 1: Enhanced Usual Ca…	Phase 1: Intervention	Phase 2: Enhanced Usual Ca…	Phase 2: Guideline Adheren…	Phase 2: Re-Randomized to …	Phase 2: Re-Randomized to …
Possible Delayed Transition	General disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04238247 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Education, incentive, and engineering-based interventions to promote the use of seat belts.
   Lourens A, Sinclair M, Willems B, Young T. · · 2024 · cited 5× · PMID 38197528 · DOI 10.1002/14651858.cd011218.pub2
2. "Tiny Cargo, Big Deal! Abróchame Bien, Cuídame 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.
   Macy ML, Carter P, Kendi S, Pollock B, et al · · 2022 · cited 4× · PMID 35918028 · DOI 10.1016/j.cct.2022.106863
3. Multimodal Intervention and Child Passenger Safety Guideline Adherence in Young Children: A Sequential, Multiple-Assignment, Randomized Clinical Trial.
   Macy ML, Pollock B, Kendi S, Goldstick J, et al · · 2025 · cited 3× · PMID 41021229 · DOI 10.1001/jamanetworkopen.2025.33912
4. Premature Child Restraint System Transitions and Child Opportunity Index Among Emergency Department and Urgent Care Visits in Metropolitan Chicago.
   Kozhumam AS, Frazier M, Macy ML. · · 2026 · cited 1× · PMID 41194313 · DOI 10.1111/acem.70187
5. Community norms and transportation safety behaviors among caregivers of children 6 months to 10 years old in chicago.
   Landa MM, Pollock B, Castillo L, Guillaume A, et al · · 2026 · PMID 41537774 · DOI 10.1080/15389588.2025.2604030
6. Demographic Patterns of Age- and Size-Appropriate Child Restraint Use in Chicago.
   Kozhumam AS, Ibrahim S, Guillaume A, Landa MM, et al · · 2026 · PMID 41448456 · DOI 10.1016/j.acap.2025.103207