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Brain Injury Education and Outpatient Navigation-1stBIEN
NCT05261477 · View on ClinicalTrials.gov ↗
Study Summary
Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report mea
Conditions Studied
Interventions
- BEHAVIORAL Bilingual Brain Injury Education and outpatient Navigation for Hispanic families
Study Locations (6)
Washington
- Harborview Medical Center - University of Washington — Seattle
- Seattle Children's Hospital — Seattle
Colorado
- Children's Hospital Colorado — Colorado Springs
Oregon
- Oregon Health & Science University — Portland
Texas
- UT Southwestern Medical Center — Dallas
Utah
- University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05261477
The ClinicalTrials.gov registry entry for NCT05261477 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 1 intervention — of which Bilingual Brain Injury Education and outpatient Navigation for Hispanic families is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05261477 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Washington, Colorado, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05261477 about?
NCT05261477 is a clinical study titled "Brain Injury Education and Outpatient Navigation-1stBIEN". Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases di...
What is the current status of trial NCT05261477?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-07-07. Estimated completion is 2026-12.
What conditions does trial NCT05261477 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic, Rehabilitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05261477?
The interventions under investigation include: Bilingual Brain Injury Education and outpatient Navigation for Hispanic families (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05261477?
This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05261477 being conducted?
This trial has 6 study locations across Colorado, Oregon, Texas, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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