Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
Recruiting
N/A
Interventional Study
Traumatic Brain Injury
Head Injury
Head Injuries, Closed
Brain Hemorrhage, Traumatic
Brain Edema
Intracranial Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 wi…