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ID
Source
Brief title
Health condition
Acquired brain injury, Traumatic brain injury, Cognitive Rehabilitation, Children, Adolescents,
Niet-aangeboren hersenletsel, Traumatisch hersenletsel, Cognitieve revalidatie, Kinderen, Jongeren, Adolescenten
Sponsors and support
Intervention
Outcome measures
Primary outcome
Three 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 outcome
Cognitive 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).
Background summary
Children and adolescents with acquired brain injury (ABI) frequently report problems with cognitive functioning and consequently problems with psychosocial functioning. While these problems are usually targeted with cognitive rehabilitation, evidence from well-designed studies into effectiveness of cognitive rehabilitation is lacking in this population. Computer-based cognitive retraining (CBCR) is a promising cognitive rehabilitation method, but has been insufficiently investigated in children and adolescents with ABI. The aim of the current study is to target cognitive functioning (i.e., attention, working memory, and executive functioning,) and consequentially psychosocial functioning (i.e., participation, family functioning and quality of life) of children and adolescents (age 8–18) with ABI by use of a CBCR combined with explicit strategy instruction. The study has a multicentre pretest-posttest trial design. There will be three time points of measurement: baseline (T0) before the start of the intervention period, post intervention (T1), and follow-up three months after the intervention (T2). Children and adolescents with ABI (n=50) who are at least 6 months post-injury and are experiencing cognitive problems will be recruited from rehabilitation centres and specialized schools during approximately 4 years (January 2016– December 2020).
All participating children and adolescents 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 45 minutes of explicit strategy instruction per week. Three 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) on each of these three tests. For a broad overview of cognitive functioning after the intervention period, additional cognitive tests have been selected as secondary outcomes. Furthermore, subjective cognitive functioning (as measured with questionnaires) and psychosocial functioning (i.e., participation, family functioning and quality of life) of children and adolescent with ABI are considered secondary study parameters.
Study objective
Children 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.
Study design
Baseline before the start of the intervention period (T0);
Post intervention (T1);
Follow-up three months after the intervention (T2).
Intervention
All 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 45 minutes of explicit strategy instruction per week.
Christine Resch
Postaddress: PO Box 616
Maastricht 6200 MD
The Netherlands
Phone: +31 (0)43 3881777
christine.resch@maastrichtuniversity.nl
Christine Resch
Postaddress: PO Box 616
Maastricht 6200 MD
The Netherlands
Phone: +31 (0)43 3881777
christine.resch@maastrichtuniversity.nl
Inclusion criteria
1. Age between 8 and 18 years;
2. Diagnosed with ABI (e.g., traumatic brain injury, brain tumour, stroke, encephalitis, meningitis, and hypoxia);
3. At least 6 months 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 criteria
1. 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5504 |
| NTR-old | NTR5639 |
| CCMO | NL54523.068.15 |
| OMON | NL-OMON47636 |