S06
Conditions
Interventions
Group 1: In the current study, 450 children and adolescents (C&A) between the ages of 6 and 17 years who have suffered a traumatic brain injury (TBI) in the last 10 years and 450 caregivers will be re
von Steinbuechel et al., 2023). Generic HRQoL will be assessed with the Pediatric Quality of Life Inventory (PedsQL
Varni et al., 1999). As covariates, various (neuro-)psychological, clinical, sociodemographic, and psychosocial variables are collected.
At the time of testing, the following (neuro)psychological tes
Wechsler, 2017) and, for 17-year-olds, of the "Wechsler Adult Intelligence Scale" (WAIS-IV
Petermann, 2012). In addition, executive functioning are assessed using the "Trail Making Test" (TMT
Reitan, 1992) and by proxy-ratings using the "Behavior Rating Inventory of Executive Function" (BRIEF
Drechsler & Steinhausen, 2013). Memory for words is tested using the "Rey Auditory and Verbal Learning Test" (RAVLT
Schmidt, 1996). Various current symptoms of C&A will be assessed in self- and proxy-reports using the "Depression Module" (PHQ-9) and the "Module to Assess Anxiety" (GAD-7) from the "PHQ-D Brief Patie
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of TBI: at least three months but no more than 10 years ago • Glasgow Coma Scale (GCS) score or clinical description of TBI severity • Outpatient status (or at start of resuming inpatient treatment) • Child or Adolescent is able to understand and answer the questions • Informed consent of child/adolescent • Informed consent of parent/legal guardian • Medical records release form
Exclusion criteria
Exclusion criteria: • Current vegetative state • Spinal cord damage • Severe mental illness before TBI (e.g., psychosis, autism, etc.) • Epilepsy before TBI • Disease leading to death • Very severe polytrauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal objective is the development of three age-specific (6 to 7, 8 to 12, and 13 to 17 years), linguistically-validated and psychometrically-tested questionnaires for the evaluation of health-related quality of life (HRQoL) after traumatic brain injury (TBI) in children and adolescents (C&A), with corresponding proxy versions for assessing HRQoL after TBI in C&A through family members. There are two consecutive study phases: pilot phase and the validation phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Comparison of HRQoL in C&A using generic vs. disease-specific questionnaires • Investigation of HRQoL in C&A depending on severity of TBI • Comparison of self- and proxy-reports • Investigation of HRQoL in C&A for different levels of cognitive functioning (impact of memory, executive functioning, vocabulary, processing speed) In general, the association of HRQoL and covariates (possible predictors) will be investigated: e.g. medical aspects concerning TBI, comorbidities, education, previous and developmental disorders, emotional state (anxiety and depression), etc. of C&A as well as the emotional state and educational background of family members. | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactKatrin Cunitz
Charlotte Fresenius Hochschule
Outcome results
None listed