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Clinical Trials/NCT03215342
NCT03215342
Completed
N/A

Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial

St. Olavs Hospital2 sites in 1 country76 target enrollmentDecember 1, 2017
ConditionsBrain Injuries

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
St. Olavs Hospital
Enrollment
76
Locations
2
Primary Endpoint
executive function in daily life
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
November 30, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

executive function in daily life

Time Frame: change from baseline up to 6 months

Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

Secondary Outcomes

  • Performance on BADS-C(change from baseline up to 6 months)
  • Score on Pediatric Quality of Life Inventory(change from baseline up to 6 months)
  • Score on ADHD Rating Scale IV(change from baseline up to 6 months)
  • Score on Child Behavior Checklist(change from baseline up to 6 months)
  • Performance on D-KEFS Trail Making Test 1-4(change from baseline up to 6 months)
  • performance on D-KEFS Color Word Interference Test(change from baseline up to 6 months)
  • Performance on NEPSY-II Social Perception test(change from baseline up to 6 months)
  • Score on Harter Self Perception Profile for Children(change from baseline up to 6 months)
  • Performance on Children's Cooking Task test(change from baseline up to 6 months)
  • Score an EQ-5D-Y(change from baseline up to 6 months)
  • Score on Cognitive Failures Questionnaire(change from baseline up to 6 months)
  • Performance on Conners Continuous Performance Test III(change from baseline up to 6 months)
  • Score on Health Behaviour Inventory(change from baseline up to 6 months)
  • Score on Glasgow Outcome Scale Extended Pediatric(change from baseline up to 6 months)
  • Score on Center for Epidemiologic Studies Depression Scale(change from baseline up to 6 months)
  • Score on Family Functioning Scale(change from baseline up to 6 months)

Study Sites (2)

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