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New program aims to help hispanic kids bounce back after brain injury

NCT ID NCT05261477

Symptom relief Sponsor: Seattle Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a bilingual program called 1stBIEN for Hispanic children (ages 3-17) recovering from traumatic brain injury. The program provides in-person education, mobile videos, and a navigator to help families access outpatient care and school support. Researchers will measure whether it improves treatment attendance and quality of life compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bilingual brain injury education and outpatient navigation program
What this could lead to
If successful, this program could improve recovery and quality of life for Hispanic children after traumatic brain injury by helping families access and stick with rehabilitation.
What could go wrong
This is a behavioral intervention, not a drug or device, so benefits may be modest. The trial is still recruiting, and results may not apply to all families or regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries, traumatic Rehabilitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital Colorado

    RECRUITING

    Colorado Springs, Colorado, 80920, United States

  • Harborview Medical Center - University of Washington

    RECRUITING

    Seattle, Washington, 98104, United States

  • Oregon Health & Science University

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Utah

    WITHDRAWN

    Salt Lake City, Utah, 84112, United States

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