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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pGMT | Experimental | Pediatric Goal Management Training |
|
| pBHW | Experimental | Pediatric Brain Health Workshop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric Goal Management Training | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kari Risnes, md phd | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo universitetssykehus HF | Oslo | Norway | ||||
| Barne og ungdomsklinikken St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375619 | Background | 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. | |
| 34724955 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2020 | Apr 3, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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|
| Pediatric Brain Health Workshop | Behavioral | 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 |
|
|
| 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 |
| Trondheim |
| Norway |
| 35925734 | Derived | 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. |
| 34197132 | Derived | 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. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |