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Child Passenger Safety Interventions for Car Accidents

N/A

Waitlist Available

Led By Michelle Macy, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow-up

Awards & highlights

Study Summary

This trial is testing whether an intervention using motivational interviewing and patient-centered eHealth materials can increase the use of proper child restraints in English and Spanish speaking caregivers of children 6 months to 10 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Passenger Safety Guideline Adherence

Child Passenger Safety Score (CPaSS)

Secondary outcome measures

CPaSS Trajectories

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced InterventionExperimental Treatment2 Interventions

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.

Group II: Basic InterventionExperimental Treatment1 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.

Group III: Enhanced Usual CareActive Control1 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.

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Find a Location

Who is running the clinical trial?

University of MichiganOTHER

1,796 Previous Clinical Trials

6,377,478 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

256 Previous Clinical Trials

5,187,405 Total Patients Enrolled

Michelle Macy, MDPrincipal Investigator - Ann & Robert H Lurie Children's Hospital of Chicago

Ann & Robert H Lurie Children's Hospital of Chicago

Media Library

Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04238247 — N/A

Car Accidents Research Study Groups: Enhanced Intervention, Basic Intervention, Enhanced Usual Care

Car Accidents Clinical Trial 2023: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention Highlights & Side Effects. Trial Name: NCT04238247 — N/A

Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04238247 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to register for this clinical trial?

"This experiment is aiming to enroll 900 candidates in the 6 months to 10 years age bracket who have experienced a traffic-related trauma. In order for them to be eligible, they must meet the following criteria: able and willing to use an appropriate car seat or booster seat; travelling unrestrained; occupying a front vehicle position; planning on relinquishing their restraint system within half a year of screening commencement; being no taller than 55 inches tall at time of assessment; having received emergency or urgent care from one of participating sites' EDs, with their legal guardian present when evaluated for recruitment into this trial. Furthermore, said guardian has to be aged 18"

Answered by AI

Is this research program currently open to enrolling participants?

"According to the details hosted on clinicaltrials.gov, this medical experiment is presently open for recruitment and was initially posted in January of 2020. The information regarding it has been most recently updated as of October 14th 2021."

Answered by AI

What is the total enrollment of participants for this experiment?

"Affirmative. Clinicaltrials.gov has data that suggests this investigation is currently in search of participants; it was initially posted on January 28th 2020 and last edited October 14th 2021. The research requires 900 people to be recruited from a single site."

Answered by AI