Clinical trial NCT03215342: Cognitive Rehabilitation in Pediatric Acquired Brain Injury
Official title: Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: Child
Rehabilitation
Psychotherapy, groups
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2017-07-12
Enrollment: 76
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.


Eligibility criteria: Inclusion Criteria:

* diagnosed with traumatic brain injury, brain tumor or damage by inflammation in the brain
* more than 12 months since injury/illness or more than 12 months since ended cancer therapy
* evidence of executive dysfunction in everyday life

Exclusion Criteria:

* cognitive, sensory, physical, or language impairment affecting the capacity to attend mainstream school and/or complete the training program
* pre-injury neurological disease or psychiatric disorder
* recently detected brain tumor relapse
* unfit for evaluation of outcome (independent evaluation by 2 investigators)
* not fluent in Norwegian language

Primary outcomes:
measure: executive function in daily life
timeFrame: change from baseline up to 6 months
Secondary outcomes:
measure: Performance on Conners Continuous Performance Test III
timeFrame: change from baseline up to 6 months
measure: Performance on BADS-C
timeFrame: change from baseline up to 6 months
measure: Performance on D-KEFS Trail Making Test 1-4
timeFrame: change from baseline up to 6 months
measure: performance on D-KEFS Color Word Interference Test
timeFrame: change from baseline up to 6 months
measure: Performance on Children's Cooking Task test
timeFrame: change from baseline up to 6 months
measure: Performance on NEPSY-II Social Perception test
timeFrame: change from baseline up to 6 months
measure: Score on Health Behaviour Inventory
timeFrame: change from baseline up to 6 months
measure: Score on Glasgow Outcome Scale Extended Pediatric
timeFrame: change from baseline up to 6 months
measure: Score an EQ-5D-Y
timeFrame: change from baseline up to 6 months
measure: Score on Family Functioning Scale
timeFrame: change from baseline up to 6 months
measure: Score on Center for Epidemiologic Studies Depression Scale
timeFrame: change from baseline up to 6 months
measure: Score on Pediatric Quality of Life Inventory
timeFrame: change from baseline up to 6 months
measure: Score on Cognitive Failures Questionnaire
timeFrame: change from baseline up to 6 months
measure: Score on ADHD Rating Scale IV
timeFrame: change from baseline up to 6 months
measure: Score on Child Behavior Checklist
timeFrame: change from baseline up to 6 months
measure: Score on Harter Self Perception Profile for Children
timeFrame: change from baseline up to 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF
city: Trondheim
country: Norway
facility: Barne og ungdomsklinikken St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Kari Risnes, md phd
role: STUDY_DIRECTOR
References:
citation: Hypher RE, Brandt AE, Risnes K, Ro TB, Skovlund E, Andersson S, Finnanger TG, Stubberud J. Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Aug 1;9(8):e029273. doi: 10.1136/bmjopen-2019-029273.
citation: Brandt AE, Finnanger TG, Hypher RE, Ro TB, Skovlund E, Andersson S, Risnes K, Stubberud J. Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial. BMC Med. 2021 Nov 2;19(1):253. doi: 10.1186/s12916-021-02129-8.
citation: Hypher R, Brandt AE, Skovlund E, Skarbo AB, Barder HE, Andersson S, Ro TB, Risnes K, Finnanger TG, Stubberud J. Metacognitive strategy training versus psychoeducation for improving fatigue in children and adolescents with acquired brain injuries: A randomized controlled trial. Neuropsychology. 2022 Oct;36(7):579-596. doi: 10.1037/neu0000845. Epub 2022 Aug 4.
citation: Hypher R, Andersson S, Finnanger TG, Brandt AE, Hoorelbeke K, Lie HC, Barder HE, Larsen SM, Risnes K, Ro TB, Stubberud J. Fatigue following pediatric acquired brain injury: Interplay with associated factors in a clinical trial population compared to healthy controls. Neuropsychology. 2021 Sep;35(6):609-621. doi: 10.1037/neu0000753. Epub 2021 Jul 1.