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

Primary Purpose

Brain Injuries

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Pediatric Goal Management Training

Pediatric Brain Health Workshop

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Child, Rehabilitation, Psychotherapy, groups

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo universitetssykehus HF
Barne og ungdomsklinikken St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

pGMT

pBHW

Arm Description

Pediatric Goal Management Training

Pediatric Brain Health Workshop

Outcomes

Primary Outcome Measures

executive function in daily life

Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

Secondary Outcome Measures

Performance on Conners Continuous Performance Test III

Performance on BADS-C

Performance on D-KEFS Trail Making Test 1-4

performance on D-KEFS Color Word Interference Test

Performance on Children's Cooking Task test

Performance on NEPSY-II Social Perception test

Score on Health Behaviour Inventory

questionnaire

Score on Glasgow Outcome Scale Extended Pediatric

questionnaire

Score an EQ-5D-Y

questionnaire

Score on Family Functioning Scale

questionnaire

Score on Center for Epidemiologic Studies Depression Scale

questionnaire

Score on Pediatric Quality of Life Inventory

questionnaire

Score on Cognitive Failures Questionnaire

Score on ADHD Rating Scale IV

questionnaire

Score on Child Behavior Checklist

questionnaire

Score on Harter Self Perception Profile for Children

questionnaire

Full Information

NCT ID

NCT03215342

First Posted

July 11, 2017

Last Updated

December 12, 2021

Sponsor

St. Olavs Hospital

Collaborators

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03215342

Brief Title

Cognitive Rehabilitation in Pediatric Acquired Brain Injury

Acronym

CORE-pABI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries

Keywords

Child, Rehabilitation, Psychotherapy, groups

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pGMT

Arm Type

Experimental

Arm Description

Pediatric Goal Management Training

Arm Title

pBHW

Arm Type

Experimental

Arm Description

Pediatric Brain Health Workshop

Intervention Type

Behavioral

Intervention Name(s)

Pediatric Goal Management Training

Other Intervention Name(s)

GMT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Pediatric Brain Health Workshop

Other Intervention Name(s)

active control condition, pBHW

Intervention Description

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

Primary Outcome Measure Information:

Title

executive function in daily life

Description

Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

Time Frame