Brain Injury Education and Navigation for Traumatic Brain Injury
(1st-BIEN Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a bilingual program called 1st BIEN for Hispanic children with traumatic brain injuries. The program includes education through videos and in-person sessions, plus support to help families access outpatient care. It aims to improve treatment adherence and reduce long-term disability.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Bilingual Brain Injury Education and outpatient Navigation for Hispanic families?
Research shows that a bilingual education and navigation program can be feasible and acceptable for Hispanic families dealing with traumatic brain injury (TBI). This approach, which includes bilingual education and support during care transitions, has been pilot tested and is designed to address the unique needs of Hispanic families, potentially improving outcomes for children with TBI.12345
Is the Brain Injury Education and Navigation program safe for humans?
How is the 1st BIEN treatment different from other treatments for traumatic brain injury?
The 1st BIEN treatment is unique because it provides bilingual education and navigation support specifically tailored for Hispanic families, using mobile phone video content and bilingual navigators to help with transitions of care and school return, addressing a gap in culturally relevant interventions for this population.12378
Research Team
Nathalia Jimenez, MD, MPH
Principal Investigator
Seattle Children's Hospital
Eligibility Criteria
This trial is for Hispanic children aged 6-17 with mild to severe traumatic brain injury (TBI) who have been hospitalized for over 24 hours and need outpatient rehab therapy. It's also for their primary caregivers, who will help with the child's recovery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Education and Initial Intervention
Participants receive one in-person education session using the 1stBIEN booklet, followed by video education via mobile phones and care coordination from a bilingual Patient Navigator for 3 months.
Follow-up
Participants are monitored for treatment adherence and functional outcomes at 3, 6, and 12 months post-discharge.
Long-term Monitoring
Ongoing assessment of child's academic performance and social participation using school records and PROMIS measures.
Treatment Details
Interventions
- Bilingual Brain Injury Education and outpatient Navigation for Hispanic families
Bilingual Brain Injury Education and outpatient Navigation for Hispanic families is already approved in United States for the following indications:
- Traumatic Brain Injury (TBI) rehabilitation for Hispanic children
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator