Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05261477 · ClinicalTrials.gov registry record · NA

Brain Injury Education and Outpatient Navigation-1stBIEN

A NA study of Brain Injuries, Traumatic and Rehabilitation, sponsored by Seattle Children's Hospital.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
6
Study locations

NCT05261477: Recruiting NA study of Brain Injuries, Traumatic and Rehabilitation, sponsored by Seattle Children's Hospital.

NCT05261477 is a NA study of Brain Injuries, Traumatic and Rehabilitation that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 300 participants, above the 242-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (24% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05261477, a NA study of Brain Injuries, Traumatic and Rehabilitation, is actively recruiting participants, sponsored by Seattle Children's Hospital.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
6
Study locations

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

Primary Outcome

Percentage of attended appointments at hospital, primary care and therapies

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

FieldValue
Enrollment Target 300 participants
Start Date 2022-07-07
Est. Completion 2026-12
Phase NA
Seattle Children's Hospital

168 total trials

What NCT05261477 shows while recruiting

NCT05261477 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (24% higher).

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.

NCT05261477 lists 6 locations in 5 states (Washington, Colorado, Oregon).

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.

What interventions are being tested in trial NCT05261477?

The interventions under investigation include: Bilingual Brain Injury Education and outpatient Navigation for Hispanic families (BEHAVIORAL).

Who is sponsoring clinical trial NCT05261477?

This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Brain Injuries, Traumatic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05261477's enrollment target sits among peer trials

300 6th of 21 higher than 16 of 21 other Brain Injuries, Traumatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Brain Injuries, Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00353483 · 300 participants

    Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

  • NCT00588185 · 300 participants · NA

    [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

  • NCT00682032 · 300 participants · NA

    The Effect of Beta-glucan in Non-Small Cell Lung Cancer

  • NCT00870064 · 300 participants · NA

    The Treatment of Type I Open Fractures in Pediatrics

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05261477, the US trial registry maintained by the National Library of Medicine. NCT05261477 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.