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

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Accident, Traffic

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04238247

HD092594

Details and patient eligibility

About

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.

Full 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.

Enrollment: 513 patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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513 participants in 3 patient groups

Enhanced Usual Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention

Enhanced Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Enhanced Intervention

Behavioral: Tiny Cargo, Big Deal/Abróchame Bien, Cuídame Bien (TCBD/ABCB) Basic Intervention