|- candidate number||25280|
|- NTR Number||NTR6086|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-sep-2016|
|- Secondary IDs||Ethical Committee nr. 2016-DP-7127 |
|- Public Title||Gaming as Gateway to Reading INnovation|
|- Scientific Title||A randomized controlled trail on the effectiveness of a game-based training of letter-speech sound associations to improve reading fluency in children with reading disabilities|
|- hypothesis||The main objective of study is to determine whether a game-based intervention focussed on intensively training automation of letter-speech-sound associations can improve reading fluency in children with reading disabilities (grade 2) and in children at risk of reading disabilities (grade 1).|
|- Healt Condition(s) or Problem(s) studied||Dyslexia|
|- Inclusion criteria||Inclusion Criteria for children with reading disabilities (grade 2)|
I. Suffering from specific and persistent problems with reading at school
II. Percentile score ≤ 25% on a standard reading test (Drie-minuten-test (DMT; three-minute-test)
III. In grade 2 of primary education
IV. Native Dutch speaker
Inclusion Criteria for children at risk for reading disabilities (grade 1)
I. Percentile score ≤ 25% on a letter knowledge test (Screeningsinstrument Beginnende Geletterdheid, CITO, 2009)
II. In grade 1 of primary education
III. Native Dutch speaker
|- Exclusion criteria||Exclusion Criteria (for all participants)|
I. Diagnosis of AD(H)D, autism spectrum disorder, (specific) language impairment
II. Neurological impairment
III. General cognitive impairment
IV. Uncorrected sight problems
V. Significant bilateral hearing loss
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-sep-2016|
|- planned closingdate||30-mei-2017|
|- Target number of participants||240|
|- Interventions||The intervention tested in this study is a cognitive, (serious) game-based intervention focused on the training of letter-speech sound associations. The goal of the intervention is to improve reading fluency in children with reading disabilities. In a series of experimental, proof-of-concept studies we previously showed that the guiding principle of using gaming techniques to intensively train letter-speech sound associations can be effective in improving reading fluency.|
|- Primary outcome||The primary outcome of this study is Word Reading Fluency, as measured by:|
3DM Word Reading Fluency Test (Blomert & Vaessen, 2009).
|- Secondary outcome||(1) Word Reading Accuracy as measured by the 3DM Word Reading Accuracy Test (Blomert & Vaessen, 2009)|
(2) Letter-speech sound integration, as measured by the Letter-Speech Sound Association Test (LKAT; Van der Kluft & Vercouteren, 2016); only for grade 2 subjects.
(3) Letter knowledge, as measured by the Letter Naming task (Smits, 2002); only for grade 1 subjects.
|- Trial web site||www.kosmosklikker.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||dr. Jurgen Tijms|
|- CONTACT for SCIENTIFIC QUERIES||dr. Jurgen Tijms|
|- Sponsor/Initiator ||Rudolf Berlin Center|
(Source(s) of Monetary or Material Support)
|Regio Gooi en Vechtstreek - Innovatiebudget Jeugd |
|- Brief summary||The main goal of the present study is to improve reading fluency in children with reading disabilities. We will therefore deliver a game-based intervention focussed on developing automatic letter-speech sound integration to children with reading disabilities, in order to attack their dysfluent reading.
The study is a single-blind randomised controlled trial comparing an intervention addressing letter-speech sound integration to a waiting list control group. The study consists of two trials:
(1) Intervention for children with reading disabilities in grade 2.
(2) Early intervention for children at risk of reading disabilities in grade 1.
Children with (a risk of) reading disabilities are randomly assigned (1 : 1) to either an immediate intervention group or a waiting-list control group by a method of simple randomisation. Participants will be randomised using a computerised random number generator. Subjects will be randomized after stratification for school. The target sample size is n = 120 children at risk of reading disabilities in grade 1, and n = 120 children with reading disabilities in grade 2
Children in the intervention condition will receive intervention during a 14 week period. These children will be provided with three intervention sessions a week for 20 minutes per session. Children allocated to the waiting-list control condition will receive the intervention program after the waiting period had elapsed.
Behavioural measures of reading, and letter-speech sound mapping are measured at baseline and at the end of the 14 week (intervention) period for both intervention group and control group.
|- Main changes (audit trail)|
|- RECORD||12-sep-2016 - 11-nov-2016|