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CompletedNCT03215342CORE-pABIUpdated Dec 14, 2021

Cognitive Rehabilitation in Pediatric Acquired Brain Injury

An interventional study of Pediatric Goal Management Training and Pediatric Brain Health Workshop in Brain Injuries, sponsored by St. Olavs Hospital. Completed at 2 sites in Norway. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injuries

Keywords

  • Child
  • Rehabilitation
  • Psychotherapy, groups
03

In context

Brain Injuries

2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 76 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    pGMT

    Pediatric Goal Management Training

    Behavioral: Pediatric Goal Management Training

  • Experimental
    pBHW

    Pediatric Brain Health Workshop

    Behavioral: Pediatric Brain Health Workshop

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.

    Also known as: GMT

  • 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

    Also known as: active control condition, pBHW

06

What researchers measure

Primary outcomes

  1. executive function in daily life

    Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

    Time frame: change from baseline up to 6 months

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

    questionnaire

    Time frame: change from baseline up to 6 months

  8. Score on Glasgow Outcome Scale Extended Pediatric

    questionnaire

    Time frame: change from baseline up to 6 months

  9. Score an EQ-5D-Y

    questionnaire

    Time frame: change from baseline up to 6 months

  10. Score on Family Functioning Scale

    questionnaire

    Time frame: change from baseline up to 6 months

  11. Score on Center for Epidemiologic Studies Depression Scale

    questionnaire

    Time frame: change from baseline up to 6 months

  12. Score on Pediatric Quality of Life Inventory

    questionnaire

    Time frame: change from baseline up to 6 months

  13. Score on Cognitive Failures Questionnaire

    Time frame: change from baseline up to 6 months

  14. Score on ADHD Rating Scale IV

    questionnaire

    Time frame: change from baseline up to 6 months

  15. Score on Child Behavior Checklist

    questionnaire

    Time frame: change from baseline up to 6 months

  16. Score on Harter Self Perception Profile for Children

    questionnaire

    Time frame: change from baseline up to 6 months

07

Study locations

2 sites
  • Oslo universitetssykehus HF
    Oslo, Norway
  • Barne og ungdomsklinikken St Olavs Hospital
    Trondheim, Norway
08

References and documents

Publications

  • 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. Erratum In: BMJ Open. 2019 Aug 23;9(8):e029273corr1. doi: 10.1136/bmjopen-2019-029273corr1. PubMed 31375619 ↗
  • 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. PubMed 34724955 ↗
  • 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. PubMed 35925734 ↗
  • 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. PubMed 34197132 ↗

Study documents

  • Statistical analysis plan · Apr 3, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03215342
Lead sponsor
St. Olavs Hospital
Collaborators
Oslo University Hospital
Responsible party
Sponsor
First posted
Jul 12, 2017
Start date
Dec 1, 2017
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Last update
Dec 14, 2021

Study contacts

Kari Risnes, md phd
study director · St. Olavs Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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