|- candidate number||5365|
|- NTR Number||NTR1688|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-feb-2009|
|- Secondary IDs||05-161 METC UMC Utrecht|
|- Public Title||Effectiveness of auditory training in children with (central) auditory processing disorders.|
|- Scientific Title||A randomised controlled trial into the effectiveness of auditory training in children with (central) auditory processing disorders.|
|- hypothesis||Auditory training will enhance auditory processing in children with auditory processing disorders.|
|- Healt Condition(s) or Problem(s) studied||Children, Auditory processing disorder|
|- Inclusion criteria||1. Children aged between 5-6 and 9-11 years;|
2. Normal peripheral hearing acuity;
3. Below normal performance in at least one of three domains of auditory processing: word recognition in noise, binaural fusion, dichotic listening.
|- Exclusion criteria||1. Below normal intelligence (IQ < 85);|
2. Language comprehension and/or language production disorder;
3. Diagnosis of learning difficulties;
4. Below normal peripheral hearing acuity (high Fletcher index below 25 dB (at 1, 2, and 4 kHz) in the better hearing ear).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2006|
|- planned closingdate||1-feb-2009|
|- Target number of participants||108|
|- Interventions||Randomized assignment to one of the following training programs:|
1. Computerized auditory training;
2. Computerized auditory training with noise;
4. Lateral trainer.
|- Primary outcome||The proportion of children below normal performance in at least one of three domains of auditory processing: word recognition in noise, binaural fusion, dichotic listening.|
|- Secondary outcome||1. Auditory processing skills in all domains of the auditory processing test battery (speech recogntion in noise test, filtered speech test, binaural fusion test, binaural competitive speech recognition test, dichotic speech recognition test, Lindamood auditory conceptualisation test);|
2. Attention skills (Test of Everyday Attention in Children);
3. Subjective measures of auditory processing skills (Children Auditory Processing Scale as completed by parents and teacher).
|- Timepoints||1. M1: Randomisation - baseline measurements;|
2. M2: after 10 weeks training;
3. M3: after a 10 week break, just before second stage of 10 weeks training;
4. M4: after second stage of 10 weeks training.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Anne G.M. Schilder|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Anne G.M. Schilder|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Stichting Kinderpostzegels Nederland|
|- Brief summary||Children with (central) auditory processing disorders can be distinguished from children with peripheral hearing loss by using an auditory processing assessment battery. The effect of training to enhance auditory processing capabilities in these children has however not been proven in a RCT. We therefore perform a RCT into the effectiveness of four training programs and compare them with a control group that did not receive training.|
108 children were included.
Inclusion criteria are:
1. Age between 5 and 9 years;
2. APD-diagnosis based on standard auditory processing tasks;
3. Normal hearing (thresholds below 15 dB);
4. Normal intelligence (Raven).
Exclusion criteria are:
1. Speech and language developmental disorders;
2. Learning and behavioural disorders.
Children were randomly assigned to one of four training groups (n=18 each) or a control group (n=36). Training consists of 2x10 weeks daily training, with a 10-weeks training-free interval. Training programs:
1. Computerized auditory training;
2. Computerized auditory training including noise;
3. FM-system in the classroom;
4. High-frequency-lateral training.
The primary outcome measure is auditory processing skills as measured by standard auditory processing tasks. Secondary outcome measures are attention, parental and teacherís report, and developmental on a subset of auditory processing tests over 4 measurement points.
|- Main changes (audit trail)|
|- RECORD||27-feb-2009 - 14-sep-2009|