|- candidate number||15141|
|- NTR Number||NTR4077|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jul-2013|
|- Secondary IDs||25/01/2013 Scientific Board s Heeren Loo|
|- Public Title||Zonder gebaren geen taal: effectiviteit van een taalinterventie waarbij de expressieve taalontwikkeling van jonge kinderen met DS wordt gestimuleerd door het implementeren van gebaarwoordcombinaties in de dagelijkse situatie.|
|- Scientific Title||Without gestures no language: effectiveness of an intervention to stimulate early expressive language development in young children with Down’s syndrome; a randomized controlled trial|
|- ACRONYM||Without Gestures No Language|
|- hypothesis||We hypothesize that by stimulation gesture-plus-word combinations the expressive language development will improve.|
|- Healt Condition(s) or Problem(s) studied||Down syndrome|
|- Inclusion criteria||1. children with Down's syndrome (18-24 months);|
2. native language is Dutch;
3. vocabualy less than 25 words (including gestures).
|- Exclusion criteria||1. moderate to severe hearing problems;|
2. other disorders that may interfere language development.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-sep-2015|
|- Target number of participants||70|
|- Interventions||The intervention "Without Gestures No Language" consists of 13 weekly treatments with a speechpathologist and daily exercises for implementing transitional gesture-plus-word combinations in the everyday situation. Duration; 13 weeks.|
|- Primary outcome||The primary outcome measure will be expressive (spoken) language which will be measured by the Communication Intention Assessment (CIA) and the Dutch version of the Communicative Development Inventories (CDI). The following aspects will be measured:|
A. Preverbal and early laguage development (conditon, form, functions and rules)
B. Expressive Vocabulary (i.e. signed and spoken words)
|- Secondary outcome||To gain insight into different variables that may affect the results, different measuring instruments will be used |
1. Bayley Scales of Infant Development, Second Edition (BSID-II-NL);
2. Checklist treatment
3. Evaluation form treatment;
4. Checklist participation for parents.
|- Timepoints||1. 01-09-2013 / 01-01-2014: preperation trial;|
2. 01-01-2014 / 01-01-2015: inclusion period;
3. 01-01-2015 / 01-09-2015: data analysis & publication.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Danielle te Kaat-van den Os|
|- CONTACT for SCIENTIFIC QUERIES|| Danielle te Kaat-van den Os|
|- Sponsor/Initiator ||Utrecht University (UU), 's Heeren Loo, Expertise Centre Advisium|
(Source(s) of Monetary or Material Support)
|Support Fund 's Heeren Loo|
|- Brief summary||The aim of the research is to evaluate the efficacy and effectiveness of the intervention which encourages the expressive language development of young children with DS by implementing transitional gesture-plus-word combinations in the everyday situation.
The intervention consists of 13 weekly treatments of 30 minutes by a speechpathologist and exercises at home in which learned gesture-plus-word combination will be implemented in daily activities. This intervention will be evaluated by comparing several outcome measures between a group of children with DS receiving the intervention and a group of children with DS who receive speech therapy as usual.
In this effectstudy the intervention will be eavluated on children with DS in the age of 18-24 months. The measurements will take place before, during and after finishing the intervention.
The research sample will be randomly divided into two groups. The experimental group will receive the intervention "Without Gestures No Language" and the control group will receive no intervention other than the regular speechtherapy that they already get. The research assistants which will perform the measurements are blinded for treatment allocation.
It is possible for the participant which were assigned to the control group, to start the intervention after the research.
|- Main changes (audit trail)|
|- RECORD||16-jul-2013 - 29-jul-2013|