Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04798859
Eligibility Criteria:
Inclusion Criteria:
* School-aged (6-16 years) children with clinical ABI-diagnosis and CT/MRI verified injury-related intracranial abnormalities, 1 year or more after injury. We anticipate including patients with the following etiologies: Traumatic brain injury (TBI), cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors.
* The above-mentioned children, and/or their parents, report ABI-related cognitive, emotional, or behavioral problems that affect participation in activities with family, friends, school and/or community.
* The children attend school regularly, with or without injury-related adaptations.
* The family is able to actively participate in a goal-oriented approach, this includes speaking sufficiently Norwegian. An exception can be made for parents who speak English but are able to understand and read Norwegian.
Exclusion criteria:
* Patients with severe pre- or comorbid neurological or neuropsychiatric disorders that would confound assessment and/or treatment outcomes.
* Patients with brain tumors in active treatment or at great risk of relapse (i.e., unstable condition).
* Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care most of the time.
* Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT04798859
Study Brief:
Protocol Section:
NCT04798859