AzTrials
AzTrials

Brain InjuriesCORE-pABINCT03215342

Cognitive Rehabilitation in Pediatric Acquired Brain Injury

A study testing Pediatric Goal Management Training and Pediatric Brain Health Workshop in people with Brain Injuries, run by St. Olavs Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Brain Injuries
What is being tested?
Pediatric Goal Management Training and Pediatric Brain Health Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesNorway
Study dates
1 Dec 2017to 30 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Oslo universitetssykehus HF

    Oslo

  • Barne og ungdomsklinikken St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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.

Conditions
Brain Injuries
Being tested
Pediatric Goal Management Training, Pediatric Brain Health Workshop
Keywords
Child, Rehabilitation, Psychotherapy, groups
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pediatric Goal Management TrainingBehavioural

    Also called GMT

    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 WorkshopBehavioural

    Also called active control condition, pBHW

    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

Study groups in NCT03215342
Study groupRoleWhat they receive
pGMTExperimentalPediatric Goal Management Training
Receives: Behavioral: Pediatric Goal Management Training
pBHWExperimentalPediatric Brain Health Workshop
Receives: Behavioral: Pediatric Brain Health Workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. executive function in daily life

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

    Measured: change from baseline up to 6 months

Secondary outcomes (16)

  1. Performance on Conners Continuous Performance Test III

    Measured: change from baseline up to 6 months

  2. Performance on BADS-C

    Measured: change from baseline up to 6 months

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

    Measured: change from baseline up to 6 months

  4. performance on D-KEFS Color Word Interference Test

    Measured: change from baseline up to 6 months

  5. Performance on Children's Cooking Task test

    Measured: change from baseline up to 6 months

  6. Performance on NEPSY-II Social Perception test

    Measured: change from baseline up to 6 months

  7. Score on Health Behaviour Inventory

    questionnaire

    Measured: change from baseline up to 6 months

  8. Score on Glasgow Outcome Scale Extended Pediatric

    questionnaire

    Measured: change from baseline up to 6 months

  9. Score an EQ-5D-Y

    questionnaire

    Measured: change from baseline up to 6 months

  10. Score on Family Functioning Scale

    questionnaire

    Measured: change from baseline up to 6 months

  11. Score on Center for Epidemiologic Studies Depression Scale

    questionnaire

    Measured: change from baseline up to 6 months

  12. Score on Pediatric Quality of Life Inventory

    questionnaire

    Measured: change from baseline up to 6 months

  13. Score on Cognitive Failures Questionnaire

    Measured: change from baseline up to 6 months

  14. Score on ADHD Rating Scale IV

    questionnaire

    Measured: change from baseline up to 6 months

  15. Score on Child Behavior Checklist

    questionnaire

    Measured: change from baseline up to 6 months

  16. Score on Harter Self Perception Profile for Children

    questionnaire

    Measured: change from baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start1 Dec 2017
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215342
Sponsor's protocol ID
2017/772
Acronym
CORE-pABI
Status last verified
Dec 2021
First submitted
11 Jul 2017
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Pediatric Goal Management Training and Pediatric Brain Health Workshop in people with Brain Injuries, run by St. Olavs Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

executive function in daily life (time frame: change from baseline up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215342, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in