Project Summary

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 3 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 3 to 6 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 1st 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 and 86% attendance to initial follow-up care. We propose a multi-center 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 (3-17 years), with mild to severe TBI and their parents, from 5 centers in 4 states with Hispanic population predominantly from Mexico and Central America. A higher risk group, whose educational attainment, income and English proficiency are lower 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 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at centralized acute facilities, community care providers and individual therapies. Secondary outcomes are functional status of the child using PROMIS parental report measures; and, parental health literacy, self-efficacy and mental health measured at 3, 6, and 12 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.

Grant Information

  • Award Number: 1R01HD103700-01A1
  • Unique Federal Award Identification Number (FAIN): R01HD103700

Clinical trials.gov NCT05261477 Unique Protocol ID: STUDY00003331 Brief Title: Brain Injury Education and Outpatient Navigation-1stBIEN (1st-BIEN) Official Title: Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN

Study Outline Specific Aims Aim 1. Test the efficacy of the 1st BIEN intervention to improve receipt of overall follow-up care and outpatient rehabilitation after a TBI among children and adolescents of Hispanic families.

  • Hypothesis 1a. Intervention group children will have higher attendance at follow-up appointments and higher initiation and attendance at outpatient therapies 6 months after discharge, compared to control children.
  • Hypothesis 1b. Intervention group children will be more likely to receive federally mandated health services through school supported Education Plans, 12 months after discharge compared to control children.

Aim 2. Determine the effect of the 1st BIEN intervention on functional outcomes and social participation after TBI among children and adolescents of Hispanic families. 

  • Hypothesis 2a. Intervention group children will have higher adaptive functioning, health related quality of life, better physical, and emotional function, at 3, 6 and 12 months after injury, compared to control children.
  • Hypothesis 2b.  Intervention group children will have higher levels of social participation measured by earlier school reintegration, receipt of educational resources; and participation in extracurricular activities. 

Exploratory Aim 3. Test possible moderators and mediators of 1st BIEN intervention effects. 

  • Exploratory analyses will test possible moderators of intervention effects (i.e. pre-injury parental acculturation and education) and possible mediators (i.e. post-intervention parental knowledge, self-efficacy, mental health).

The data generated by this research will establish the effectiveness of culturally relevant TBI interventions to improve access to TBI rehabilitation and overall care for Hispanic children. It will inform future work with existing community organizations to improve outreach to a vulnerable, fast-growing minority population.

Design and Outcomes Design overview:

Based on social cognitive theory, the study evaluates the impact of an education and navigation intervention on parental TBI knowledge (health literacy) and complementary skills for improving parents’ advocacy and TBI caregiving self-efficacy. It also tests if improving access to care results in better child’s functional outcomes. (Figure 1) One hundred and fifty parent-child dyads will be recruited for the study. Hispanic children 6 to17 years of age, with mild-complicated to severe TBI and their parent/caregiver (referred as parent), will be recruited at the time of

discharge from 5 academic centers in the U.S. After consent, we assess baseline information on child function pre-injury and at discharge, and parents’ TBI caregiving self-efficacy, and health literacy levels. All parents receive in-person instruction using a culturally and linguistically appropriate TBI education manual reviewing content directly relevant to the child’s injury. After randomization, participants in the intervention arm receive additional education on problem solving training skills and TBI refresher videos delivered every 2 weeks via mobile phone devices plus navigation over the course of 3-months. (See Intervention section). Participants in the attention control group receive monthly texts with age-appropriate well-child information and follow-up care as usual from their health care providers.

Intervention Enhanced parental education, consists of continuous education reinforcing key

knowledge and advocacy skills, using mobile phone-compatible videos sent to parents every two weeks tailored to child and family needs. (Figure 4), Intervention families receive, 6-8 videos. Patient Navigators (PNs) at each institution tailor video delivery according to child and family needs. Videos have an approximate duration of 4 minutes, give a short explanation of a specific theme emphasizing the advocacy role of parents by providing specific cues for action. Videos use lay language and graphics to exemplify concepts following a similar format to the written materials to ensure that all delivered information is consistent; when appropriate, problem-solving strategies are also incorporated. At the end of the videos a survey link asks viewers to rate video content. English and Spanish versions are stored in a study web-site available to participating centers. Bilingual culturally competent outpatient navigation: Families randomized to the intervention group continue contact with the PN after discharge from the hospital. Based on initial baseline assessments of parents’ TBI caregiving self-efficacy and literacy, and on child’s needs, the PN will assess specific barriers for accessing outpatient care, follow-up appointments with specialists at the hospital, and barriers to care for their child at home. Patient navigators are trained to: (1) provide care coordination for outpatient rehabilitation, follow-up with specialists and primary care providers; (2) facilitate use of community resources such as transportation; and (3) support communication with teachers and school administrators to ease school transitions and enable receipt of federally mandated education resources; Section 504 plan accommodations and formal Individualized Education Plans (IEP). Key to the PN role is modeling skills for parents, using three way calls for scheduling of services and interactions with clinics and schools. This strategy ensures experiential learning and just-in time education of families. Expert physician providers (co-investigators in each institution) supervise PNs.

Outcomes and Assessments Primary outcome: is treatment adherence at 6 months after discharge measured by percentage of follow-up appointments attended during the prescribed time at centralized acute facilities, community primary care providers and individual therapy sessions in the community. Proportion of patients who receive therapies covered by federally mandated programs through the school system are also measured. Secondary outcomes: are (1) Child Measures:

  1. functional independent (FIM) measured by trained assessors at participating institutions.
  2. parent reported measures:
  • communication and self-care skills assessed by Adaptive Behavior Assessment (ABAS) scales, -physical and emotional PROMIS measures
  • health related quality of life (PedsQL); and

   3. academic performance using school records. (2) Parents’ measures:

  1. TBI caregiving self-efficacy measured by the Caregiver Self-efficacy (CSE) and the Community self-efficacy scales (COMSE) and
  2. psychosocial well-being of parent, using PROMIS anxiety and depression measures.

Post-intervention measures of functional status of the child, parental health literacy and self-efficacy are assessed via telephone interview by an independent blinded research assistant at 3, 6, and 12 months after injury for intervention and control groups. Outpatient records for intervention and control arms will be gathered at 6 months to determine rehabilitation and overall healthcare utilization; including functional independence measures. School records are gathered for the school years before and after the TBI.

Discover more about our clinical trial by visiting: Brain Injury Education and Outpatient Navigation-1stBIEN