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Search / Trial NCT05261477

Brain Injury Education and Outpatient Navigation-1stBIEN

Launched by SEATTLE CHILDREN'S HOSPITAL · Feb 18, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Hispanic Or Latino Child Brain Injuries, Traumatic Patient Navigation Rehabilitation

ClinConnect Summary

The 1stBIEN trial is studying a new program designed to help Hispanic families navigate the challenges of recovering from a traumatic brain injury (TBI) in children. This program includes bilingual education sessions and regular video content delivered through mobile phones to help parents understand their child's condition and the rehabilitation process. The goal is to make it easier for families to keep up with follow-up appointments and support their child's recovery after leaving the hospital.

To participate in this trial, children aged 3 to 17 who are Hispanic and have been diagnosed with a mild to severe TBI can enroll, along with their primary caregiver. Participants in the program will receive personalized education and support for three months, while another group will receive standard care. Throughout the study, researchers will track how well families stick to treatment plans, how the child is doing functionally, and the overall well-being of the parents. This trial aims to improve care for Hispanic children with TBIs and could set a standard for supporting families in similar situations.

Gender

ALL

Eligibility criteria

  • Children Inclusion criteria:
  • 1. Children 3 to 17 years of age,
  • 2. Hispanic ethnicity
  • 3. Diagnosis of mild, moderate or severe TBI.
  • 4. Hospitalization at one of the 5 academic institutions participating in this trial,
  • 5. Treatment requiring at least one type of rehabilitation therapy as outpatient
  • Parent Inclusion Criteria:
  • 1. Hispanic ethnicity
  • 2. Being the primary caregiver for the child (For longitudinal follow-up purposes)
  • Exclusion criteria:
  • Child:
  • 1. Prior neurological deficits,
  • 2. Acquired brain injuries secondary to other conditions different from trauma.
  • 3. Traumatic brain injuries secondary to abusive trauma.
  • Parent:
  • 1. Loss of custody of the child (i.e. abusive head trauma)
  • 2. Inability to be contacted by phone

About Seattle Children's Hospital

Seattle Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital focuses on developing new treatments and therapies that address the unique medical needs of children. With a commitment to excellence, Seattle Children's Hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to ensure rigorous scientific standards and ethical practices in all its clinical investigations. By prioritizing patient safety and scientific integrity, the hospital aims to contribute to the global body of knowledge in pediatric medicine and improve outcomes for children with various health conditions.

Locations

Salt Lake City, Utah, United States

Seattle, Washington, United States

Dallas, Texas, United States

Portland, Oregon, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Colorado Springs, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Nathalia Jimenez, MD, MPH

Principal Investigator

Seattle Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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