Cognitive Rehabilitation in Pediatric Acquired Brain Injury

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: Pediatric Goal Management Training
* Behavioral: Pediatric Brain Health Workshop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pGMT<br>Pediatric Goal Management Training | Behavioral: Pediatric Goal Management Training<br>* 7 GMT modules will be administered in 7x2 hours sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving. Homework assignments between sessions.<br>* Other names: GMT;|
| Experimental: pBHW<br>Pediatric Brain Health Workshop | Behavioral: Pediatric Brain Health Workshop<br>* 7 pBHW modules will be administered in 7x2 hours sessions (ten groups). Psychoeducation; brain (dys)function, plasticity, memory, executive function, and attention. Stress, physical exercise, sleep, nutrition, and energy management. Homework assignments between sessions<br>* Other names: pBHW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| executive function in daily life | Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form | change from baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on Conners Continuous Performance Test III |  | change from baseline up to 6 months | 
| Performance on BADS-C |  | 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 Children's Cooking Task test |  | change from baseline up to 6 months | 
| Performance on NEPSY-II Social Perception test |  | change from baseline up to 6 months | 
| Score on Health Behaviour Inventory | questionnaire | change from baseline up to 6 months | 
| Score on Glasgow Outcome Scale Extended Pediatric | questionnaire | change from baseline up to 6 months | 
| Score an EQ-5D-Y | questionnaire | change from baseline up to 6 months | 
| Score on Family Functioning Scale | questionnaire | change from baseline up to 6 months | 
| Score on Center for Epidemiologic Studies Depression Scale | questionnaire | change from baseline up to 6 months | 
| Score on Pediatric Quality of Life Inventory | questionnaire | change from baseline up to 6 months | 
| Score on Cognitive Failures Questionnaire |  | change from baseline up to 6 months | 
| Score on ADHD Rating Scale IV | questionnaire | change from baseline up to 6 months | 
| Score on Child Behavior Checklist | questionnaire | change from baseline up to 6 months | 
| Score on Harter Self Perception Profile for Children | questionnaire | change from baseline up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Rehabilitation, Psychotherapy, groups