Accident, TrafficNCT04238247
Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
A study testing Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention and Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention in people with Accident, Traffic, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Accident, Traffic
- What is being tested?
- Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention and Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official 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
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.
Read the 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.
- Conditions
- Accident, Traffic
- Being 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
- Keywords
- child restraint systems (car seats and booster seats), seat belts, Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12-Month Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start5 Feb 2020
- Primary completion29 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accident, TrafficStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Michelle Macy, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Michelle Macy, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238247
- Sponsor's protocol ID
- HD092594
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2020
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results, the study protocol, statistical analysis plan, and informed consent forms will be shared.
Publications
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.
PubMed 41021229Macy 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.
PubMed 35918028
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04238247
- Acronym / sponsor ID
- HD092594
- Conditions
- Accident, Traffic
- Keywords
- child restraint systems (car seats and booster seats), seat belts, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic InterventionParticipants 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. |
| Enhanced Intervention | Experimental | 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 InterventionAfter 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. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic InterventionA 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. | Behavioural | Basic Intervention, Enhanced Intervention |
| Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced InterventionThe 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. | Behavioural | Enhanced Intervention |
Primary outcome
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41021229Macy 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.
- Derived from this study: PubMed 35918028Macy 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results, the study protocol, statistical analysis plan, and informed consent forms will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Macy, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention and Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention in people with Accident, Traffic, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Guideline Adherent Child Passenger Safety Behaviors at 6 Months (time frame: 6-Month Assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.