Cognitive Rehabilitation in Pediatric Acquired Brain Injury

Brain Injuries Clinical Trial

— CORE-pABI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215342
• Other study ID #: 2017/772
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2021
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Norway	Oslo universitetssykehus HF	Oslo
Norway	Barne og ungdomsklinikken St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Brandt AE, Finnanger TG, Hypher RE, Rø 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 — View Citation

Hypher RE, Brandt AE, Risnes K, Rø 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. — View Citation

Outcome

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