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Computer training and strategy instruction for children and adolescents with acquired brain injury.


- candidate number23587
- NTR NumberNTR5639
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2016
- Secondary IDsNL54523.068.15 METC azM/UM 
- Public TitleComputer training and strategy instruction for children and adolescents with acquired brain injury.
- Scientific TitleComputer-based cognitive retraining (CBCR) combined with explicit strategy instruction for children and adolescents with acquired brain injury (ABI).
- ACRONYMBrainLevel
- hypothesisChildren and adolescents with acquired brain injury who receive the computer-based cognitive retraining combined with the explicit strategy instruction will show significantly more improvement of cognitive functioning (i.e., attention, working memory, and executive functioning) and psychosocial functioning (i.e., participation, family functioning and quality of life) compared to children who only receive care as usual.
- Healt Condition(s) or Problem(s) studiedAcquired brain injury, Cognitive functioning, Young adults, Children, Adolescents
- Inclusion criteria1. Age between 8 and 17 years (i.e., before they turn 18);
2. Diagnosed with ABI (e.g., traumatic brain injury, brain tumour, stroke, encephalitis, meningitis, and hypoxia);
3. At least 6 months with a maximum of 2 years post injury;
4. Experiencing problems with at least one of the to be trained cognitive functions (i.e., attention, working memory, or executive functioning);
5. Patient in a rehabilitation centre or student at a specialized school;
6. Able to control the arrow keys of a keyboard and/or to use a computer mouse and visually able to perceive a complete screen and to adequately process the stimuli of the computer games and the neuropsychological tests;
- Exclusion criteria1. General level of intelligence lower than 80;
2. Co-morbidity: extreme sensibility for visual stimuli, epilepsy, depression, or other health complaints or learning disabilities which can negatively influence the participation in the present study;
3. Previously present brain damage (i.e., already suffered a brain damage some years ago) or central nervous system disease (e.g., epilepsy);
4. Has previously trained with a CBCR program
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate31-jul-2018
- Target number of participants120
- InterventionsAll participating children and adolescents will receive care as usual. In addition, participants in the intervention group will be offered a 6–week CBCR program targeting a wide range of cognitive functions (i.e., attention, working memory, and executive functioning) combined with explicit strategy instruction. Participants train 5 times a week for approximately 30 minutes and attend 1 hour of explicit strategy instruction per week.
- Primary outcomeThree cognitive tests have been selected as primary outcome measures to assess change in attention (score on d2), working memory (score on Corsi Block-Tapping Test), and executive functioning (score on Concept Shifting Task). The main study parameters are the change in performance from baseline measurement (T0) to post intervention measurement (T1, i.e., 6 to 8 weeks after T0) and the change from T1 to T2 (follow-up after 3 months) on each of these three tests.
- Secondary outcomeCognitive functioning:
1. Intelligence: WISC-III short form
2. Attention: Coding (WISC-III); Five to Fifteen questionnaire (parent and teacher version)
3. Working memory: Digit Span (WISC-III)
4. Executive functioning: Stop Signal Reaction Task; Verbal Fluency; Behavioral Rating Inventory of Executive Functioning (parent version).

Psychosocial functioning:
1. Participation: Child and Adolescent Scale of Participation (parent and child version)
2. Family functioning: Family Assessment Device - General Functioning (parent version)
3. Quality of life: Pediatric Quality of Life Inventory - Generic core scale and Multidimensional fatigue scales (parent and child version).
- TimepointsBaseline before the start of the intervention period (T0);
Post intervention (T1);
Follow-up three months after the intervention (T2).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Christine Resch
- CONTACT for SCIENTIFIC QUERIESDr. C. Heugten, van
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting, Cornelia Stichting, Fonds Adriaanstichting
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD8-jan-2016 - 23-aug-2016


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