Actively Recruiting

Phase Not Applicable
Age: 3Years +
All Genders
ID05261477

Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN

Led by Seattle Children's Hospital · Updated on 2026-01-13

300

Participants Needed

6

Research Sites

22 weeks

Total Duration

On this page

Sponsors

S

Seattle Children's Hospital

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying traumatic brain injury (TBI) in Hispanic children, who face higher long-term disability and lower quality of life compared to non-Hispanic children despite similar hospital discharge outcomes. The study aims to test a bilingual, culturally tailored program called 1st BIEN that combines brain injury education with outpatient care navigation to improve long-term adherence to rehabilitation and reduce disability. This intervention addresses barriers Hispanic families face in accessing and maintaining outpatient treatments, including knowledge gaps and language challenges. The trial involves two groups: the intervention group receives one in-person education session, weekly tailored video education via mobile phones, and three months of bilingual patient navigation to support transitions to outpatient care and school reintegration. The control group receives one in-person education session, monthly well-child text messages, and usual follow-up care. The study enrolls 150 Hispanic children aged 3 to 17 years with mild to severe TBI and their primary caregiver parents across five U.S. centers. Participants will be followed for up to 12 months after hospital discharge with assessments at multiple time points. Researchers will measure treatment adherence by tracking attendance at follow-up appointments and outpatient therapies. They will also evaluate children's functional status, health-related quality of life, social participation, and academic performance. Parental health literacy, self-efficacy, and mental health will be measured. The study includes training and monitoring of patient navigators to ensure consistent delivery of the intervention.

CONDITIONS

Brief Title

Brain Injury Education and Outpatient Navigation-1stBIEN

Who Can Participate

Age: 3Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children 3 to 17 years of age
  • Hispanic ethnicity
  • Diagnosis of mild, moderate, or severe traumatic brain injury (TBI)
  • Hospitalized at one of the 5 participating academic institutions
  • Requires at least one type of outpatient rehabilitation therapy
  • Parent is of Hispanic ethnicity
  • Parent is the primary caregiver for the child
Not Eligible

You will not qualify if you...

  • Child has prior neurological deficits
  • Child has acquired brain injuries from non-traumatic causes
  • Child has traumatic brain injuries caused by abusive trauma
  • Parent has lost custody of the child (e.g., abusive head trauma)
  • Parent is unable to be contacted by phone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Education and Enrollment

Duration - 1 day

Participants receive one in-person education session using the 1stBIEN booklet that provides culturally and linguistically tailored traumatic brain injury information to parents.

1 visit (in-person)

Outpatient Navigation and Video Education (Intervention group only)

Duration - 3 months

Parents in the intervention group receive telephone-based patient navigation for 3 months to support outpatient rehabilitation adherence and care coordination. Weekly navigation calls occur during the first month, followed by monthly calls for two months. Video education is provided weekly via mobile phone to reinforce brain injury knowledge and advocacy skills.

Weekly calls for 1 month, then monthly calls for 2 months; weekly video education sessions

Standard Follow-up Care (Control group only)

Duration - 12 months

Parents in the control group receive monthly well-child texts and usual post-injury care including routine follow-up by specialists and primary care providers per institutional guidelines.

Monthly texts; routine follow-up visits as per standard care

Follow-up Assessments

Duration - 12 months

Participants are followed up at multiple timepoints to evaluate functional outcomes, social participation, and quality of life at 3, 6, and 12 months after hospital discharge.

Visits or assessments at 3, 6, and 12 months after discharge

Trial Site Locations

Total: 6 locations

1

Children's Hospital Colorado

Colorado Springs, Colorado, United States, 80920

Actively Recruiting

2

Oregon Health & Science University

Portland, Oregon, United States, 97239

Active, Not Recruiting

3

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

4

University of Utah

Salt Lake City, Utah, United States, 84112

Withdrawn

5

Harborview Medical Center - University of Washington

Seattle, Washington, United States, 98104

Actively Recruiting

6

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

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Research Team

M

Maria A Oliva, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Feasibility and Acceptability of a Telephone-Based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury: A Pilot Study.

Nathalia Jimenez, Molly Fuentes, Alyssa Virtue...

https://pubmed.ncbi.nlm.nih.gov/33656480

Bilingual randomized controlled trial design, of a telephone-based intervention to promote rehabilitation adherence; A study focus on recruitment of Hispanic children with traumatic brain injury.

Nathalia Jimenez, Cydni N Williams, Heather Keenan...

https://pubmed.ncbi.nlm.nih.gov/37852531