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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT03215342
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: St. Olavs Hospital
• Public title: Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial CORE-pABI
• Scientific title: Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial
• Date of first enrolment: December 1, 2017
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03215342
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Kari Risnes, md phd
• Affiliation: St. Olavs Hospital

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Brain Injuries

Intervention(s)

Behavioral: Pediatric Goal Management Training

Behavioral: Pediatric Brain Health Workshop

Primary Outcome(s)

executive function in daily life [Time Frame: change from baseline up to 6 months]

Secondary Outcome(s)

Score on Pediatric Quality of Life Inventory [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 ADHD Rating Scale IV [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]

Score on Harter Self Perception Profile for Children [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 Conners Continuous Performance Test III [Time Frame: change from baseline up to 6 months]

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

Score on Health Behaviour Inventory [Time Frame: change from baseline up to 6 months]

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

Score on Glasgow Outcome Scale Extended Pediatric [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]

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

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

Score on Cognitive Failures Questionnaire [Time Frame: change from baseline up to 6 months]

Secondary ID(s)

2017/772

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oslo University Hospital