Brain Injury Education and Outpatient Navigation-1stBIEN
Recruiting now · Not applicable
Conditions studied: Brain Injuries, Traumatic, Rehabilitation
In brief
Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.
Key facts
- Study ID
- NCT05261477
- Run by
- Seattle Children's Hospital
- People needed
- 300
- Starts
- 2022-07-07
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-13
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Child:
- Prior neurological deficits,
- Acquired brain injuries secondary to other conditions different from trauma.
- Traumatic brain injuries secondary to abusive trauma.
- Parent:
- Loss of custody of the child (i.e. abusive head trauma)
- Inability to be contacted by phone
Where it is running
- Children's Hospital Colorado — Colorado Springs, Colorado, United States (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Harborview Medical Center - University of Washington — Seattle, Washington, United States (enrolling)
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.