Brain Edema, Brain Hemorrhage, Traumatic, Head Injuries, Closed, Head Injury, Intracranial Edema, Traumatic Brain Injury
Conditions
Brief 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).
Detailed description
The early recovery period constitutes a critical window to set families on a positive road-to-recovery by supporting parental self-care, positive parent-child interactions, and awareness of potential longer-term concerns. The latter would facilitate parental recognition of behavioral and psychosocial needs that might otherwise go unmet. Recognizing that (1) caregivers of children who have sustained TBI are at risk of worsening psychological health and that (2) caregiver functioning and parenting behaviors have a direct impact on child recovery and outcomes; intervening and supporting caregivers in the acute phase following injury may set children and families on a positive path to recovery. Intervening at the acute phase may reduce the cascading effects of parental burden/distress and concomitant negative parent-child interactions on child recovery and functioning over time. Because families of children with TBI and other chronic health conditions may have difficulty accessing services due to transportation and cost issues, particularly lower income families, the R2R-TBI program is designed to be accessed via any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet connection. We will also offer the intervention (via tablet) to parents while they wait for their child to complete outpatient therapies (e.g., speech, physical, and occupational therapy). Delivery of web-based behavioral health interventions may reduce barriers to help-seeking and promote evidence-based interventions that are both accessible and efficient.
Interventions
BEHAVIORALRoad-to-recovery
R2R-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.
Sponsors
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 with imagining abnormalities or GCS 3-12 with or without imaging abnormalities * Admitted overnight to the hospital * 0-3 months post-discharge
Exclusion criteria
The caregiver will be excluded from participation if any of the following occur: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent post-traumatic symptoms | Change from baseline at 4-6 weeks post-intervention | Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms |
| Parent anxiety | Change from baseline at 4-6 weeks post-intervention | 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 | Change from baseline at 4-6 weeks post-intervention | 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 |
| Parenting self-efficacy | Change from baseline at 4-6 weeks post-intervention | Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent mindful self-care | Change from baseline at 4-6 weeks post-intervention | Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors |
| Parent resilience | Change from baseline at 4-6 weeks post-intervention | Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience |
| Family Functioning | Change from baseline at 4-6 weeks post-intervention | Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning |
| Family Burden of Injury | Change from baseline at 4-6 weeks post-intervention | Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden |
| Child Socioemotional Functioning | Change from baseline at 4-6 weeks post-intervention | Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Moderators of treatment effects | 4-6 weeks | Examining household income and baseline caregiver distress as moderator of treatment effects |
Countries
United States
Contacts
Primary ContactShari Wade, PhD
Backup ContactStacey Raj
Outcome results
None listed