Status:
COMPLETED
The Child in Context Intervention Study
Lead Sponsor:
Sunnaas Rehabilitation Hospital
Collaborating Sponsors:
The Research Council of Norway
Oslo University Hospital
Conditions:
Rehabilitation
Brain Injuries
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of e...
Detailed Description
There is considerable knowledge about how to help children with ABI during the first, acute and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability of children's d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04798859
Start Date
May 10 2021
End Date
December 6 2023
Last Update
December 13 2023
Active Locations (1)
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1
Sunnaas Rehabilitaion Hospital
Nesoddtangen, Akershus, Norway, 1453