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Completed

NCT Number: NCT03215342

Cognitive Rehabilitation in Pediatric Acquired Brain Injury

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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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo universitetssykehus HF, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GMT

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

Other names: active control condition, pBHW

Primary outcomes

  1. 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

  1. Performance on Conners Continuous Performance Test III

    Time frame: change from baseline up to 6 months

  2. Performance on BADS-C

    Time frame: change from baseline up to 6 months

  3. Performance on D-KEFS Trail Making Test 1-4

    Time frame: change from baseline up to 6 months

  4. performance on D-KEFS Color Word Interference Test

    Time frame: change from baseline up to 6 months

  5. Performance on Children's Cooking Task test

    Time frame: change from baseline up to 6 months

  6. Performance on NEPSY-II Social Perception test

    Time frame: change from baseline up to 6 months

  7. Score on Health Behaviour Inventory

    Time frame: change from baseline up to 6 months

    questionnaire

  8. Score on Glasgow Outcome Scale Extended Pediatric

    Time frame: change from baseline up to 6 months

    questionnaire

  9. Score an EQ-5D-Y

    Time frame: change from baseline up to 6 months

    questionnaire

  10. Score on Family Functioning Scale

    Time frame: change from baseline up to 6 months

    questionnaire

  11. Score on Center for Epidemiologic Studies Depression Scale

    Time frame: change from baseline up to 6 months

    questionnaire

  12. Score on Pediatric Quality of Life Inventory

    Time frame: change from baseline up to 6 months

    questionnaire

  13. Score on Cognitive Failures Questionnaire

    Time frame: change from baseline up to 6 months

  14. Score on ADHD Rating Scale IV

    Time frame: change from baseline up to 6 months

    questionnaire

  15. Score on Child Behavior Checklist

    Time frame: change from baseline up to 6 months

    questionnaire

  16. Score on Harter Self Perception Profile for Children

    Time frame: change from baseline up to 6 months

    questionnaire

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Acronym: CORE-pABI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2017
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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