“Tiny Cargo, Big Deal! Abróchame Bien, Cuídame 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

Background: Motor vehicle collisions remain a leading cause of unintentional injury deaths among children in the United States despite the proven effectiveness of child restraint systems (CRS). Laws and public education campaigns have fallen short of ensuring child passenger safety guideline adherence (i.e., correct use of a size-appropriate CRS in the back seat on every trip) across the population. Methods: This randomized controlled trial will test the efficacy of Tiny Cargo, Big Deal!/Abróchame Bien, Cuídame Bien (TCBD/ABCB), a precision prevention intervention, grounded in Self-Determination Theory, that integrates motivational interviewing and tailored eHealth components to promote child passenger safety guideline adherence over the course of one year. Using in-person and remote recruitment, we seek to enroll 900 English or Spanish-speaking adult caregivers of children 6 months to 10 years of age who sought emergency or urgent care and screened non-adherent to child passenger safety guidelines. Eligible caregivers provide informed consent and complete a baseline assessment before randomization. At 6 months, only intervention group participants who remain non-adherent are re-randomized to standard or enhanced intervention. We assess caregiver-submitted photographs throughout the year using the Child Passenger Safety Score and provide personalized feedback. The primary outcome of guideline adherence is assessed at 12-months. The trial has been registered with clinicaltrials.gov: NCT04238247. Implications: We hypothesize TCBD/ABCB will be more efficacious than enhanced usual care for promoting guideline adherence at 12-month follow-up. The intervention is expected to benefit children in families who have not responded to legal requirements and population-based strategies for child passenger safety.