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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: Pediatric Goal Management Training; Behavioral: Pediatric Brain Health Workshop

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
executive function in daily life	Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form	change from baseline up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance on Conners Continuous Performance Test III		change from baseline up to 6 months
Performance on BADS-C		change from baseline up to 6 months
Performance on D-KEFS Trail Making Test 1-4		change from baseline up to 6 months
performance on D-KEFS Color Word Interference Test		change from baseline up to 6 months
Performance on Children's Cooking Task test		change from baseline up to 6 months
Performance on NEPSY-II Social Perception test		change from baseline up to 6 months
Score on Health Behaviour Inventory	questionnaire	change from baseline up to 6 months
Score on Glasgow Outcome Scale Extended Pediatric	questionnaire	change from baseline up to 6 months
Score an EQ-5D-Y	questionnaire	change from baseline up to 6 months
Score on Family Functioning Scale	questionnaire	change from baseline up to 6 months
Score on Center for Epidemiologic Studies Depression Scale	questionnaire	change from baseline up to 6 months
Score on Pediatric Quality of Life Inventory	questionnaire	change from baseline up to 6 months
Score on Cognitive Failures Questionnaire		change from baseline up to 6 months
Score on ADHD Rating Scale IV	questionnaire	change from baseline up to 6 months
Score on Child Behavior Checklist	questionnaire	change from baseline up to 6 months
Score on Harter Self Perception Profile for Children	questionnaire	change from baseline up to 6 months

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Kari Risnes, md phd, St. Olavs Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (ACTUAL): July 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Child; Psychotherapy, groups
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 2017/772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No