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 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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Road-to-recovery
Treatment groups
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Nationwide Children's Hospital
Collaborator