Bilingual randomized controlled trial design, of a telephone-based intervention to promote rehabilitation adherence; A study focus on recruitment of Hispanic children with traumatic brain injury.

Background: While Hispanic children experience large long-term disparities in disability after traumatic Brain Injury (TBI), there is a gap in evidenced-based interventions to improve outcomes among this rapidly growing and at high-risk population. We developed and pilot tested a bilingual/bicultural intervention informed by Hispanic families consisting of Brain Injury Education and outpatient Navigation (1st BIEN). It integrates bilingual in-person education enriched by video content delivered through mobile phone devices, with outpatient navigation by bilingual and bicultural navigators during transitions of care and school return.

Methods: Randomized controlled trial to test the efficacy of 1st BIEN to maintain long-term adherence to rehabilitation and determine its effect on children's functional outcomes. The primary outcome is treatment adherence at 6 months post-discharge at centralized acute facilities and community providers. Secondary outcomes are functional status of the child using PROMIS parental report measures and parental health literacy, self-efficacy, and mental health; measured at baseline (pre-injury and discharge) 3-,6- and 12- months post discharge. Children's academic performance is assessed using school records the year before and the year after injury.

Discussion: Our study evaluates a novel, flexible and scalable approach using mobile phone devices to aid transitions of care, increase treatment adherence and improve TBI outcomes. It addresses the needs of an understudied population and builds upon their strengths. It is implemented by a bilingual and bicultural team with a deep understanding of the study population. It can serve as a model for TBI family centered interventions for at risk groups.

Trial Registration: ClinicalTrials.govNCT05261477. Registered on March 2, 2022.