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Efficacy of BrainGame Brian training in children born very preterm


- candidate number22753
- NTR NumberNTR5365
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-aug-2015
- Secondary IDsNL54163.018.15 
- Public TitleEfficacy of BrainGame Brian training in children born very preterm
- Scientific TitleEfficacy of the BrainGame Brian training in children born very preterm with attention problems
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedPremature infants, Brain development
- Inclusion criteriaAged 8 to 12
Born < 30 weeks of gestation and/or with a birthweight < 1000 gram
Parent reported attention problems
- Exclusion criteriaIQ < 80 on short version of the WISC-III-NL
Motorical problems too severe to allow use of a computer
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate
- Target number of participants210
- InterventionsBrainGame Brian training, Placebo, No treatment
- Primary outcomeAttention problems reported by parents and teachers on the Strengths and Weaknesses of ADHD symptoms and Normal behavior rating scale (SWAN)
- Secondary outcomeNeurocognitive outcomes (attention, executive functions), questionnaire outcomes (attention, executive functions) and school abilities (math, reading)
- Timepointspre training, 2 weeks post training, 5 months post training
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES C.A. van Houdt
- CONTACT for SCIENTIFIC QUERIES C.A. van Houdt
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kinderpostzegels Nederland, Cornelia Stichting
- Publications
- Brief summaryIn the Netherlands, every year around 2150 children are born very preterm (<30 weeks of gestation). These children will encounter bheavioral problems and problems at school when they grow up. Deficiencies in executive functions are thought to be one of the most important underlieing causes of these problems. Training executive functions is a promising new method to reduce the weak perfromance in school and the behavioral problems in this population. The BrainGame Brian training has recently been developed to train executive functions in children. The study objectives are to investigate whether the BrainGame Brian training leads to a significant decrease in attentional problems and whether these improvements generalize to school performance (maths and reading).
- Main changes (audit trail)
- RECORD17-aug-2015 - 6-okt-2015


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