Bilingual education and navigation program for Hispanic children with brain injuries

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

This study is testing a bilingual education and support program to help Hispanic families with children who have brain injuries access and stick with rehabilitation services for better recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: Seattle Children's Hospital (Academic / other)
• Locations: 6 sites (Colorado Springs, Colorado and 5 other locations)
• Trial ID: NCT05261477 on ClinicalTrials.gov

What this trial studies

This intervention focuses on providing bilingual brain injury education and outpatient navigation specifically designed for Hispanic families with children who have experienced traumatic brain injuries (TBI). The program addresses barriers faced by these families, such as language and health literacy, by integrating in-person education with mobile video content. It aims to improve access to and adherence to outpatient rehabilitation services, which are crucial for long-term recovery. The intervention is based on a culturally relevant framework and includes support for parents as primary caregivers during their child's rehabilitation journey.

Who should consider this trial

Good fit: Ideal candidates for this program are Hispanic children aged 3 to 17 years who have been diagnosed with mild, moderate, or severe TBI and require outpatient rehabilitation.

Not a fit: Patients who have prior neurological deficits or whose brain injuries are due to non-traumatic causes may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly improve the rehabilitation outcomes and quality of life for Hispanic children recovering from traumatic brain injuries.

How similar studies have performed: While education and navigation programs have shown efficacy in improving treatment adherence for chronic conditions, this specific approach for TBI in Hispanic children is novel and has not been previously tested.

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

Where this trial is running

Colorado Springs, Colorado and 5 other locations

• Children's Hospital Colorado — Colorado Springs, Colorado, United States (Recruiting)
• Oregon Health & Science University — Portland, Oregon, United States (Active_not_recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Withdrawn)
• Harborview Medical Center - University of Washington — Seattle, Washington, United States (Recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Nathalia Jimenez, MD, MPH — Seattle Children's Hospital
• Study coordinator: Maria A Oliva, MS

Conditions Brain Injuries, Traumatic; Rehabilitation; Hispanic or Latino; Child; Patient Navigation