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Train the brain: changing learning processes in children with ADHD


- candidate number22892
- NTR NumberNTR5444
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2015
- Secondary IDsEthical Committe nr: G-2015 01 156  Grant provider nr: G073814N
- Public TitleTrain the brain: changing learning processes in children with ADHD
- Scientific TitleChanging associative learning processes in ADHD
- ACRONYM
- hypothesisThe purpose of the study is to investigate whether we can ameliorate (associative) learning processes in children with ADHD by training working memory. We predict that children in the active working memory training condition will show improved short term memory, working memory & learning processes, whilst children in the non-active working memory training condition will show no improvements in these parameters.
- Healt Condition(s) or Problem(s) studiedADHD
- Inclusion criteria- Between 8 and 12 years old
- The presence of a primary clinical diagnosis of any subtype of ADHD
- The presence of a clinical score on the ADHD scales of the Questionnaire Behavior problems for Children from 6 to 16 (VvGK 6-16)
- The presence of a primary clinical diagnosis of any subtype of ADHD based on the Diagnostic Interview Schedule for Children (PDISC-IV) - module E (Behavioral disorders): Parents' form.
- IQ > 80 measured by the short version of the Wechsler Intelligence Scale for Children (WISC-III-NL)
- Medication (e.g. Methylfenidate) has to be stable for at least four weeks before pretest and stopped 48 hour before the testing sessions.
- Exclusion criteria- The presence of a clinical diagnosis on conduct disorder (CD) as measured by the Diagnostic Interview Schedule for Children (PDISC-IV) - module E (Behavior disorders): Parents' form
- The presence of a diagnosis of Autism Spectrum Disorders (ASD) as indicated by the parents
- The presence of a neurological disorder, a sensory or motor deficit as indicated by the parents on the general questionnaire.
- Medication that causes behavioral changes or has an influence on attention or concentration, except for methylphenidate and dexamphetamine.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-okt-2017
- Target number of participants60
- InterventionsBraingame Brian is a game based working memory training consisting of 25 sessions with a duration approximately around 45 minutes. It consist of an interactive game world in which children with ADHD solve problems through completing tasks training working memory, inhibition and cognitive flexibility, which can be adaptive (active) or non-adaptive (non-active/placebo).
In the current study, at random half of the children with ADHD will receive a non-adaptive (placebo condition) trraining of working memory, cognitive flexibility and inhibition. The other half of the Children will receive an adaptive (active) working memory training and a non-adaptive cognitive flexibility and inhibition training.
- Primary outcome-Associative learning as measured by a matching to sample task with condition discrimination
-Working memory/short term memory capacity measured through the Corsi Block Tapping Task (backward/forward)
- Secondary outcome-ADHD symptoms as measured by the Questionnaire Behavior problems for Children from 6 to 16 (VvGK 6-16) parents & teachers' form
-academic performance measured by a student performance tracking system (leerling volg systeem; LVS)
- Timepointspretest
posttest
3 months follow-up
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Saskia Oord, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Saskia Oord, van der
- Sponsor/Initiator Katholieke Universiteit Leuven
- Funding
(Source(s) of Monetary or Material Support)
FWO
- Publicationsn/a
- Brief summaryThe purpose of the study is to investigate whether we can improve basic (associative) learning processes in ADHD by training the working memory through a game-based working memory training. Previous research has shown that children in the active condition improved in working memory whilst those in the non-active did not (Dovis et al., 2015), however effects of training this working memory on basic learning processes is to date unclear. Children with ADHD (N=60) will be randomized to either an active game based working memory training or a non-active working memory training. Pre, post and 3 months follow-up tests will be conducted. Primary outcomes are associative learning & working/short term memory, secondary outcomes are academic performance, and parent/teacher rated ADHD symptoms.
- Main changes (audit trail)
- RECORD22-sep-2015 - 22-nov-2015


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