Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital Medical Center, Cincinnati

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Nationwide Children's Hospital

Collaborator