R01HD103700

Brain Injury Outpatient Education and Care Navigation - Project Summary/Abstract

Disability after traumatic brain injury (TBI) significantly affects U.S. Hispanic children. Compared to non-Hispanic children, they have lower health-related quality of life, self-care, and communication skills three years after injury, even though differences are not present at hospital discharge. Long-term rehabilitation improves outcomes, but timely initiation is key since most functional gains happen three to six months after TBI. Parents play a significant role in their child's recovery. However, Hispanic parents face substantial barriers that can result in delayed treatment initiation and suboptimal outcomes.

We developed and pilot tested the first theory-based intervention for Hispanic children and their parents consisting of brain injury education and outpatient navigation (1st BIEN). Based on social cognitive theory, 1st BIEN integrates in-person education enriched by video content delivered through mobile phone devices, with outpatient navigation during transitions from inpatient to outpatient care and during school return. The 1st BIEN pilot established feasibility and acceptability for our program, with 86% attendance to initial follow-up care.

We propose a multicenter 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. We will enroll 150 parent-child dyads; children aged 6-17 years with moderate to severe TBI and their parents, from five centers in four states with a Hispanic population predominantly from Mexico and Central America. This group has a higher risk, with lower educational attainment, income, and English proficiency compared to other Hispanic groups in the U.S.

Parents randomized to the intervention will receive (1) one in-person education session, using the culturally, linguistically, and literacy relevant 1st BIEN booklet, plus bi-weekly video reviews individually tailored to the child's TBI and therapies; and (2) three months of bilingual outpatient navigation, modeling, and coaching problem-solving skills. Attention control parents will receive one in-person education session using the 1st BIEN booklet, monthly non-TBI (well-child) texts, and usual institutional follow-up care.

The primary outcome is treatment adherence at six months post-discharge, measured by the percentage of follow-up appointments attended during the prescribed time at centralized acute facilities, community care providers, and individual therapies. Secondary outcomes are the functional status of the child using PROMIS parental report measures, and parental health literacy, self-efficacy, and mental health measured at three, six, and twelve months after discharge. Children's academic performance will also be assessed using school records.

Exploratory analyses will test possible moderators such as pre-injury parental acculturation, and mediators such as post-intervention parental TBI-knowledge, self-efficacy, anxiety, and depression. 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 can serve as a model for TBI family-centered interventions for at-risk groups.

Seattle Children's Hospital

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Washington United States

State-Wide

NICHD Research Project Grant (R01 - Clinical Trial Required) (PA-18-480)

Amendment Since initial award the End Date has been shortened from 04/30/26 to 04/30/25 and the total obligations have increased 381% from $703,975 to $3,389,312.