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Cognitive Rehabilitation in Pediatric Acquired Brain Injury (CORE-pABI)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified July 2017 by St. Olavs Hospital
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT03215342
First received: July 11, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
  Purpose
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.

Condition Intervention
Brain Injuries Behavioral: Pediatric Goal Management Training Behavioral: Pediatric Brain Health Workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Performance on Conners Continuous Performance Test III [ Time Frame: change from baseline up to 6 months ]
  • Performance on BADS-C [ Time Frame: change from baseline up to 6 months ]
  • Performance on D-KEFS Trail Making Test 1-4 [ Time Frame: change from baseline up to 6 months ]
  • performance on D-KEFS Color Word Interference Test [ Time Frame: change from baseline up to 6 months ]
  • Performance on Children's Cooking Task test [ Time Frame: change from baseline up to 6 months ]
  • Performance on NEPSY-II Social Perception test [ Time Frame: change from baseline up to 6 months ]
  • Score on Health Behaviour Inventory [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Glasgow Outcome Scale Extended Pediatric [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score an EQ-5D-Y [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Family Functioning Scale [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Center for Epidemiologic Studies Depression Scale [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Pediatric Quality of Life Inventory [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Cognitive Failures Questionnaire [ Time Frame: change from baseline up to 6 months ]
  • Score on ADHD Rating Scale IV [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Child Behavior Checklist [ Time Frame: change from baseline up to 6 months ]
    questionnaire

  • Score on Harter Self Perception Profile for Children [ Time Frame: change from baseline up to 6 months ]
    questionnaire


Estimated Enrollment: 80
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pGMT
Pediatric Goal Management Training
Behavioral: 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.
Other Name: GMT
Experimental: pBHW
Pediatric Brain Health Workshop
Behavioral: 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 Names:
  • active control condition
  • pBHW

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03215342

Contacts
Contact: Jan Stubberud, phd +47 95104217 jan.stubberud@hotmail.com
Contact: Kari Risnes, md phd +47 95170397 kari.risnes@ntnu.no

Locations
Norway
Oslo universitetssykehus HF Not yet recruiting
Oslo, Norway
Contact: Jan Stubberud, phd    +47 95104217    jan.stubberud@hotmail.com   
Barne og ungdomsklinikken St Olavs Hospital Not yet recruiting
Trondheim, Norway
Contact: Kari Risnes, phd    +47 95170397    kari.risnes@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
Oslo University Hospital
Investigators
Study Director: Kari Risnes, md phd St. Olavs Hospital
  More Information

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03215342     History of Changes
Other Study ID Numbers: 2017/772
Study First Received: July 11, 2017
Last Updated: July 11, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Child
Rehabilitation
Psychotherapy, groups

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2017