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NCT05622461
Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
Conditions: Traumatic Brain Injury, Head Injury, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema, Intracranial Edema
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
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).
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 hospitalSustained 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 abnormalitiesAdmitted overnight to the hospital0-3 months post-dischargeExclusion Criteria:The caregiver will be excluded from participation if any of the following occur:Child did not survive the injuryChild sustained a non-blunt head trauma (e.g.
gunshot wound)Child does not reside with parent/caregiver for study durationEnglish is not primary language spoken in the home
Source: ClinicalTrials.gov (NCT05622461). StuddyBuddy aggregates publicly available trial information.