Education and Care Navigation Program for Hispanic Children Ages 3-17 with Traumatic Brain Injury
Improving Rehabilitation Adherence and Outcomes Through Bilingual Support
Led by Seattle Children's Hospital · Updated on 2026-01-13
300
Participants Needed
6
Research Sites
22 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying traumatic brain injury TBI in Hispanic children, who face higher long-term disability and lower quality of life compared to non-Hispanic children despite similar hospital discharge outcomes. The study aims to test a bilingual, culturally tailored program called 1st BIEN that combines brain injury education with outpatient care navigation to improve long-term adherence to rehabilitation and reduce disability. This intervention addresses barriers Hispanic families face in accessing and maintaining outpatient treatments, including knowledge gaps and language challenges.
The trial involves two groups the intervention group receives one in-person education session, weekly tailored video education via mobile phones, and three months of bilingual patient navigation to support transitions to outpatient care and school reintegration. The control group receives one in-person education session, monthly well-child text messages, and usual follow-up care. The study enrolls 150 Hispanic children aged 3 to 17 years with mild to severe TBI and their primary caregiver parents across five U.S. centers.
Participants will be followed for up to 12 months after hospital discharge with assessments at multiple time points. Researchers will measure treatment adherence by tracking attendance at follow-up appointments and outpatient therapies. They will also evaluate childrens functional status, health-related quality of life, social participation, and academic performance. Parental health literacy, self-efficacy, and mental health will be measured. The study includes training and monitoring of patient navigators to ensure consistent delivery of the intervention.
CONDITIONS
Brief Title
Brain Injury Education and Outpatient Navigation-1stBIEN
Research Team
M
Maria A Oliva, MS
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
1stBIEN bilingual education + navigation
Attention control: education + texts
Usual outpatient rehabilitation
What it is
A bilingual bicultural program combining in‑person education, tailored videos, and outpatient care navigation to support Hispanic families of children with TBI.
One in‑person education session plus monthly well‑child text messages alongside usual follow‑up care.
Typical outpatient rehabilitation following pediatric TBI includes structured therapy services (physical, occupational, speech) delivered post‑discharge according to standard clinical pathways.
Role in the trial
Intervention being tested to improve adherence and outcomes post‑hospital discharge.
Control condition providing minimal attention via education and texts for comparison.
Represents usual outpatient rehabilitation pathway outside of the study.
Primary use
To improve follow‑up care adherence and parental self‑efficacy in managing the child’s recovery after TBI.
To control for attention while delivering basic education and usual follow‑up care.
To provide the standard set of outpatient therapies and follow‑up services typically offered post‑TBI.
How it is given or performed
Delivered through an initial in‑person session, followed by bi‑weekly mobile‑friendly videos and 3 months of bilingual outpatient navigation support.
Begins with one in‑person education session followed by monthly well‑child text messages plus usual institutional follow‑up visits.
Outpatient therapy sessions scheduled according to clinical need over weeks to months following discharge.
Evidence status
Evidence pending from the randomized trial; earlier pilot studies showed feasibility and acceptability in Hispanic families.
Used as baseline comparator; no evidence of improved adherence beyond usual care.
Outpatient rehabilitation is evidence‑based standard for promoting recovery after pediatric TBI.
Important risks
No specific risks reported; low‑risk behavioral intervention.
Minimal risk associated with educational content and texts.
Physical therapies may involve standard risks such as fatigue or discomfort, managed by clinicians.
Important limitations
Effectiveness not yet established; limited to Hispanic families in select states; scalability needs testing.
Provides only minimal additional support; may not reflect usual local engagement levels.
Access and consistency vary; families may face language, literacy, or system‑navigation barriers.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 3Years +
All Genders
Eligibility Criteria
You may qualify if you...
Children 3 to 17 years of age
Hispanic ethnicity
Diagnosis of mild, moderate, or severe traumatic brain injury (TBI)
Hospitalized at one of the 5 participating academic institutions
Requires at least one type of outpatient rehabilitation therapy
Parent is of Hispanic ethnicity
Parent is the primary caregiver for the child
You will not qualify if you...
Child has prior neurological deficits
Child has acquired brain injuries from non-traumatic causes
Child has traumatic brain injuries caused by abusive trauma
Parent has lost custody of the child (e.g., abusive head trauma)
Parent is unable to be contacted by phone
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Education and Enrollment
Duration - 1 day
Participants receive one in-person education session using the 1stBIEN booklet that provides culturally and linguistically tailored traumatic brain injury information to parents.
1 visit (in-person)
Outpatient Navigation and Video Education (Intervention group only)
Duration - 3 months
Parents in the intervention group receive telephone-based patient navigation for 3 months to support outpatient rehabilitation adherence and care coordination. Weekly navigation calls occur during the first month, followed by monthly calls for two months. Video education is provided weekly via mobile phone to reinforce brain injury knowledge and advocacy skills.
Weekly calls for 1 month, then monthly calls for 2 months; weekly video education sessions
Standard Follow-up Care (Control group only)
Duration - 12 months
Parents in the control group receive monthly well-child texts and usual post-injury care including routine follow-up by specialists and primary care providers per institutional guidelines.
Monthly texts; routine follow-up visits as per standard care
Follow-up Assessments
Duration - 12 months
Participants are followed up at multiple timepoints to evaluate functional outcomes, social participation, and quality of life at 3, 6, and 12 months after hospital discharge.
Visits or assessments at 3, 6, and 12 months after discharge
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
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.
Nathalia Jimenez, Cydni N Williams, Heather Keenan...
Feasibility and Acceptability of a Telephone-Based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury: A Pilot Study.