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).
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
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
Parallel
Road-to-recovery
BehavioralR2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.
Parent anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Parent anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety
Parent depression
Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology
Parent depression
Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology
Family Functioning
Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning
Family Functioning
Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning
Family Burden of Injury
Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden
Family Burden of Injury
Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden
Moderators of treatment effects
Examining household income and baseline caregiver distress as moderator of treatment effects
Moderators of treatment effects
Examining household income and baseline caregiver distress as moderator of treatment effects
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Nationwide Children's Hospital
Collaborator
