Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
Recruiting now · Not applicable
Conditions studied: Traumatic Brain Injury, Head Injury, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema, Intracranial Edema
In brief
This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).
Key facts
- Study ID
- NCT05622461
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 200
- Starts
- 2023-02-13
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Caregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria:
- Ages 3 months to 18 years at time of discharge from hospital
- Sustained a complicated mild to severe TBI as defined by a Glasgow Coma Scale (GCS) of 13-15 with imagining abnormalities or GCS 3-12 with or without imaging abnormalities
- Admitted overnight to the hospital
- 0-3 months post-discharge
You may not qualify if…
- The caregiver will be excluded from participation if any of the following occur:
- Child did not survive the injury
- Child sustained a non-blunt head trauma (e.g. gunshot wound)
- Child does not reside with parent/caregiver for study duration
- English is not primary language spoken in the home
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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