|- candidate number||22322|
|- NTR Number||NTR5223|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-jun-2015|
|- Secondary IDs||2015-1618 NL52647.091.15|
|- Public Title||Working memory training in children with neuropsychiatric disorders and mild to borderline intellectual disabilities|
|- Scientific Title||Working memory training in children with neuropsychiatric disorders and mild to borderline intellectual disabilities|
|- ACRONYM||WMT in children with neuropsychiatric disorders and MBID|
|- hypothesis||-Children who receive the more prolonged working memory training with personalized coaching have less behavioural problems (VISK, AVL, BRIEF) after the training compared to children who receive the more prolonged working memory training without personalized coaching.
- Children who receive the more prolonged working memory training with personalized coaching show more improvent in neurocognitive functioning (working memory: spatial span, backward digit recall, listening recall; Executive functioning: Sustained Attention Dots, Go-Nogo; Transfer effect: begrip van instructie) after the training compared to children who receive the more prolonged working memory training without personalized coaching.
- Children who receive the more prolonged working memory training with personalized coaching will have better scores in school achievement (Arithmetic:Tempo Toets Rekenen; reading: Brus 1 minuut) after the training compared to children who receive the more prolonged working memory training without personlized coaching.
|- Healt Condition(s) or Problem(s) studied||ADHD, Autism Spectrum Disorders (ASDs), Cognitive functioning, Behavioral problems|
|- Inclusion criteria||1. Children aged between 10 years/0 months and 13 years/11 months, known in psychiatric health care and/or special education.|
2. Neuropsychiatric disorders (ADHD, ASD, or a combination of those two), classified by the DSM-IV/ DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 2000, 2013).
3. IQ score between 60 and 85.
4. Access to a PC with Windows Vista or Windows XP with internet connection and speakers at school
|- Exclusion criteria||1. Treatment at an inpatient or day treatment clinic.|
2. Regular use of other medication than for ADHD or ASD
4. If medication for ADHD/ASD is used and ‘room for improvement for ADHD symptoms’ is absent
3. Diagnosis of one or more of the following comorbid psychiatric disorders (checked by DISC-IV):
- Major depression
- Bipolar disorder
- Psychotic disorder
- Conduct disorder
- Anxiety disorder
- Neurological disorders (e.g. epilepsy) in the recent two years.
- Cardiovascular disease currently or in the past.
- Serious motor and/or perceptual handicap.
- Participation in another clinical trial simultaneously.
- Insufficient motivation to follow the training.
- Medical illness which needs medical treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jan-2017|
|- Target number of participants||50|
|- Interventions||In a double blind randomized controlled trial, two groups with 25 children will train 8 weeks, 4 days a week for an average of 35 minutes (5 exercises) each day. Parents, children and teachers will be blind for the allocation to one of the two groups, i.e. active personalized coaching and feedback or no personalized (only general non-personalized coaching) coaching. Before and after training, all children will undergo a behavioral and neurocognitive assessment including academic achievement measures (pre- en post- assessment). In the week after the last session, the post-assessment will be done and an evaluation of the training will take place. Six months after the last training session there will be a follow-up.
a)One group will be treated with a less intensive but more prolonged version of the Cogmed © WMT, version R/M and will receive active personalized coaching and feedback each week based on their actual performance during the training.|
b)One group will be treated with a less intensive but more prolonged version of the Cogmed © WMT, version R/M. They will receive the same amount of coaching time, but without personalized (only general non-personalized coaching) coaching.
Cogmed © WMT has been developed by Cogmed Cognitive Medical Systems AB (Stockholm, Sweden). Pearson is the official publisher for the Netherlands for Cogmed. BeterBrein provides the educational program to become a licensed Cogmed coach.
|- Primary outcome||The primary objective is to investigate the effect of a less intensive but prolonged Cogmed© RM working memory training with active personalized coaching and feedback in children with MBID and neuropsychiatric disorders, compared to a less intensive but prolonged RM Cogmed © working memory training without personalized (only general non-personalized coaching) coaching and feedback, on neurocognitive functioning measured with the span-board task.
|- Secondary outcome||Secondary, the effect of active personalized coaching will be investigated on various other neurocognitive functioning domains (working memory and executive functioning), academic achievements (arithmetic and reading) and behavioural problems and parenting style. |
|- Timepoints||The primary outcome and secondary outcomes will be measured three times; once before the working memory training, one week after completing the working memory training and six months after completing the working memory training. The timepoints are equal for participants in the intervention and placebo condition.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. Sammy L. Roording-Ragetlie|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Dorine Slaats|
|- Sponsor/Initiator ||Karakter kinder- en jeugdpsychiatrie|
(Source(s) of Monetary or Material Support)
|Anthonia Wilhelmina Fonds, Karakter Kinder- en Jeugdpsychiatrie, Fonds Psychische Gezondheid|
|- Brief summary||Working memory training (WMT) has been shown to offer therapeutic benefits to both patients with ADHD and patients with Mild to Borderline Intellectual Disabilities (MBID;60|
|- Main changes (audit trail)|
|- RECORD||9-jun-2015 - 28-jun-2016|