To investigate the efficacy of a less intensive but more prolonged Cogmed © RM WMT (including active personalized coaching and feedback) in reducing behavioral symptoms and improving neurocognitive functioning and academic achievements in children…
ID
Source
Brief title
Condition
- Other condition
- Cognitive and attention disorders and disturbances
Synonym
Health condition
neuropsychiatrische stoornissen en een licht verstandelijke beperking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The scores in behavioural problems ( VISK, AVL, BRIEF, APQ) before and after
training
-The scores in neurocognitive functioning (Working memory: spatial span,
backward digit recall, listening recall; Executive functioning: Sustained
Attention Dots, Go-Nogo; Understanding instruction: begrip van instructie)
before and after training.
-The scores in school achievement (Arithmetic:Tempo Toets Rekenen; reading:
Brus 1 minuut) before and after training.
Secondary outcome
not applicable
Background 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;60Van der Molen et al., 2010). However, additional research is needed since most
studies failed to find robust evidence for transfer effects of WMT to
behavioral symptoms and daily functioning (Chacko et al., 2103; Melby-Lervag &
Hulme, 2013). Furthermore, studies that included a placebo control group did
not show treatment benefits of WMT over a placebo training, in line with the
pilot results of our own study in children with neurodevelopmental disorders
and MBID (Roording-Ragetlie et al., ongoing research [METC protocol nr
NL32435.091.10]; Van der Donk et al, submitted; Van Dongen-Boomsma et al.,
2014). Due to the inclusion of a placebo-controlled version and the
double-blind design of these studies, children received non-specific coaching
(not based on their actual training performance). Active coaching based on
personal training results -equal to coaching in clinical practice- might
enlarge the efficacy of Cogmed WMT (Van Dongen-Boomsma et al., 2014). In the
present study, therefore the effect of active, personalized coaching and
feedback during the Cogmed WMT will be examined in children with MBID and
neuropsychiatric disorders. Since children with MBID may have a lower WM
capacity than children with an average intelligence level, they will receive a
less intensive and more prolonged Cogmed WMT. A lower WM baseline at start may
influence daily duration of the training and coherent motivation (overall
training is more difficult for this population). Prolonged but less intensive
training might fit these children better (Richtlijn Effectieve Interventies
LVB, 2011).
Study objective
To investigate the efficacy of a less intensive but more prolonged Cogmed © RM
WMT (including active personalized coaching and feedback) in reducing
behavioral symptoms and improving neurocognitive functioning and academic
achievements in children with MBID and neuropsychiatric disorders.
Study design
Double-blind randomised controlled intervention study
Intervention
Two groups, each containing 25 children, will receive a less intensive but
prolonged Cogmed© WMT at home or at school, version R/M for 8 weeks, 4 days a
week, 35 minutes a day. This is a prolonged version of the original 5 week-
Cogmed training, 5 days a week, 50 minutes a day. One group will receive weekly
active personalized coaching and feedback based on their actual performance
during the Cogmed training. This active coaching is part of the regular Cogmed
training in clinical practice. The other group will not receive personalized
coaching and feedback (only general non-personalized coaching). Before and
after training, both groups will undergo a neurocognitive assessment (pre- and
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 a follow-up will take place.
Study burden and risks
Risks will be considered minimal. Possible minor effects as headache or
sleeping problems will be assessed in recent study (protocol NL32435.091.10).
Utrechtseweg 320 Utrechtseweg 320
Oosterbeek 6862 BC
NL
Utrechtseweg 320 Utrechtseweg 320
Oosterbeek 6862 BC
NL
Listed location countries
Age
Inclusion criteria
- Childeren between 10 years/0months and 13 years /11months, known in psychiatric health care and/or special education
- Neuropsychiatric disorders (ADHD, ASD, or a combination of those two, possibly in combination with comorbid ODD), classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000, 2013).
- IQ score between 60-85
- Access to a PC with Windows Vista or Windows XP with internet connection and speakers (at home or 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52647.091.15 |