Cognitive Rehabilitation in Pediatric Acquired Brain Injury

Not Applicable

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Pediatric Goal Management Training; Behavioral: Pediatric Brain Health Workshop

• Registration Number: NCT03215342
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2017-12-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-12
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pGMT	Pediatric Goal Management Training	Pediatric Goal Management Training
pBHW	Pediatric Brain Health Workshop	Pediatric Brain Health Workshop

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Oslo universitetssykehus HF; 🇳🇴 Oslo, Norway

Barne og ungdomsklinikken St Olavs Hospital; 🇳🇴 Trondheim, Norway