Cognitive Rehabilitation in Pediatric Acquired Brain Injury
NCT ID: NCT03215342
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2017-12-01
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pGMT
Pediatric Goal Management Training
Pediatric Goal Management Training
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.
pBHW
Pediatric Brain Health Workshop
Pediatric Brain Health Workshop
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
Interventions
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Pediatric Goal Management Training
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.
Pediatric Brain Health Workshop
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Kari Risnes, md phd
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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Oslo universitetssykehus HF
Oslo, , Norway
Barne og ungdomsklinikken St Olavs Hospital
Trondheim, , Norway
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2017/772
Identifier Type: -
Identifier Source: org_study_id