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Cognitive Rehabilitation in Pediatric Acquired Brain Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03215342
Acronym
CORE-pABI
Enrollment
76
Registered
2017-07-12
Start date
2017-12-01
Completion date
2019-11-30
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

Child, Rehabilitation, Psychotherapy, groups

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.

Interventions

BEHAVIORALPediatric 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.

BEHAVIORALPediatric 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

Sponsors

Oslo University Hospital
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
executive function in daily lifechange from baseline up to 6 monthsBehavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

Secondary

MeasureTime frameDescription
Score on Harter Self Perception Profile for Childrenchange from baseline up to 6 monthsquestionnaire
Performance on Conners Continuous Performance Test IIIchange from baseline up to 6 months
Performance on BADS-Cchange from baseline up to 6 months
Performance on D-KEFS Trail Making Test 1-4change from baseline up to 6 months
performance on D-KEFS Color Word Interference Testchange from baseline up to 6 months
Performance on Children's Cooking Task testchange from baseline up to 6 months
Performance on NEPSY-II Social Perception testchange from baseline up to 6 months
Score on Child Behavior Checklistchange from baseline up to 6 monthsquestionnaire
Score on Glasgow Outcome Scale Extended Pediatricchange from baseline up to 6 monthsquestionnaire
Score an EQ-5D-Ychange from baseline up to 6 monthsquestionnaire
Score on Family Functioning Scalechange from baseline up to 6 monthsquestionnaire
Score on Center for Epidemiologic Studies Depression Scalechange from baseline up to 6 monthsquestionnaire
Score on Pediatric Quality of Life Inventorychange from baseline up to 6 monthsquestionnaire
Score on Cognitive Failures Questionnairechange from baseline up to 6 months
Score on ADHD Rating Scale IVchange from baseline up to 6 monthsquestionnaire
Score on Health Behaviour Inventorychange from baseline up to 6 monthsquestionnaire

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026