- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04238247
Tiny Cargo, Big Deal! An ED-Based Study of Child Passenger Safety Behaviors
Tiny Cargo, Big Deal! An Adaptive ED-Based eHealth Intervention to Promote Correct and Consistent Size-Appropriate Child Passenger Safety Behaviors and Reduce Disparities
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Enhanced Usual Care
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. |
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Experimental: Basic Intervention
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. |
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. |
Experimental: Enhanced Intervention
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. |
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Passenger Safety Guideline Adherence
Time Frame: 12 month follow-up
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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.
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12 month follow-up
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Child Passenger Safety Score (CPaSS)
Time Frame: 12 month follow-up
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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.
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12 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPaSS Trajectories
Time Frame: 12 month follow-up
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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.
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12 month follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michelle Macy, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HD092594
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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