Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
NCT Number: NCT04238247
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.
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Notify Me6 month–10 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Child refers to the child of the caregiver (parent/legal guardian) who is being evaluated for recruitment and participation in the study.
Inclusion criteria
Exclusion criteria
Exclusions applied only to in-person recruitment in the ED:
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 TCBD/ABCB Intervention includes a second motivational interviewing session. Basic Intervention text messages continue with an additional 1-2 tailored text messages per month.
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
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
Time frame: 12-Month Assessment
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.
Time frame: 12-Month Assessment
At the 12-month follow-up assessment, we obtained 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.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Tiny Cargo, Big Deal! An Adaptive ED-Based eHealth Intervention to Promote Correct and Consistent Size-Appropriate Child Passenger Safety Behaviors and Reduce Disparities
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