1. To investigate the efficacy of Cogmed working memory training in reducing behavioral symptoms in children with neuropsychiatric disorders and borderline intellectual functioning.2. To investigate whether WM training improves neurocognitive…
ID
Source
Brief title
Condition
- Other condition
- Developmental disorders NEC
Synonym
Health condition
neuropsychiatrische stoornissen en een ontwikkelingsachterstand
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The measured difference in behavioral problems before and after training
-The measured difference in neurocognitive functioning before and after training
-The measured difference in schoolachievement before and after training
Secondary outcome
Side effects (headache, extreme tiredness, sleepingproblems).
Background summary
It is important to develop evidence-based treatments for children with
borderline intellectual functioning (BIF; 70disorders, because regular cognitive-behavioural therapies are often to complex
due to lower intellectual abilities and less developed adaptive skills. This
group is of particular interest, because 40% of the children with an IQ between
70 and 85 have a psychiatric disorder. A total of approximately 14,8% of this
group of children are found to meet the DSM-IV symptom criteria for ADHD and
1,5% for pervasive developmental disorder not otherwise specified (PDD-NOS;
Dekker & Koot, 2003).
Working memory training has been shown effective in children with
attention-deficit/hyperactivity disorder. Previous studies have found
significant improvements in behavioural- and neurocognitive problems, i.e.
attention, hyperactivity-impulsivity, visual and verbal working memory, complex
reasoning skills, visual-spatial skills and problem solving skills (Klingberg
et al., 2005; Gibson et.al., 2006). Working memory training has also been shown
effective in other populations, including children with acquired brain injuries
(Van *t Hooft et.al., 2007) and children with mild intellectual disabilities
(MID; 50found to improve as well as the academic achievements (van der Molen, et al.,
2010). A pilot study on the effects of working memory training in children in
special education classes showed improvements in working memory, problem
solving abilities and academic achievements up to six months after training
(Dahlin, Myrberg and Klingberg; data presented at the Scandinavian conference
of dyslexia, 2005). Results of these previous studies indicate positive effects
of working memory training in children with neuropsychiatric disorders and
lower intelligence. However, the effects of working memory training have not
yet been studied in a stringent defined group of children with borderline
intellectual functioning (BIF; 70Attention-deficit/hyperactivity disorder and Autism spectrum disorders) .
Cogmed© working memory training (Klingberg et al., 2005) is at this point one
of the most promising neurocognitive training possibilities for children with
ADHD (and related disorders), available in the Netherlands. In this training
program (working) memory tasks will be trained daily on a computer. So far,
Cogmed has not been studied on effectiveness and safety (regarding side
effects) in a child psychiatric population with bordeline intellectual
disabilities (BIF). One of the benefits of a cognitive training over medication
might be the absence of (serious) side effects. However, this has not been
studied in children with neuropsychiatric disorders and BIF.
This study will investigate the effectiveness and safety of working memory
training in this double-diagnosis group in a double blind randomized controlled
trial. If the Cogmed working memory training will be proven effective in this
group of children, as shown by improvements in working memory ánd in behavioral
symptoms, this treatment may contribute to a better quality of life of the
patients and their families.
Study objective
1. To investigate the efficacy of Cogmed working memory training in reducing
behavioral symptoms in children with neuropsychiatric disorders and borderline
intellectual functioning.
2. To investigate whether WM training improves neurocognitive functioning and
academic achievements in children with neuropsychiatric disorders and
borderline intellectual functioning.
3. To investigate the safety of the Cogmed working memory training in this
group of patients, in terms of side effects (headache, extreme tiredness,
sleepingproblems).
Study design
In a double blind randomized controlled trail, two groups, each containing 50
children, will be compared. The duration of the training for three groups is 30
minutes, 5 days a week for 5 weeks. Before and after the training, all children
will undergo a neurocognitive assessment (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. Three months after the last training session
there will be a follow-up.
a) One group will be treated with the Cogmed© working memory training, version
R/M.
b) One group will be treated with a control version of Cogmed. The control
training version is exactly the same and looks the same as the WM training that
will be used in the treatment condition, but with a lower WM load (i.e., less
number of items to be remembered). In the control version, the level of
difficulty will still depend on how well the child performs, but there is a
limit of two to three items to show up, so that the child is not able to get to
a higher level than 3. Previous studies on Cogmed Working Memory training
program for children above 7 years old have shown that this version functions
well as a control condition (Klingberg et al., 2002a; Klingberg et al., 2005a).
When asked after completing the training, children all reported they were
convinced they had been training in the treatment group. Both conditions have
been developed by Cogmed Cognitive Medical Systems AB (Stockholm, Sweden) and
translated by BeterBrein, the official Licensed Practice in the Netherlands for
Cogmed, represented by Kathryn Ralph (Kathryn.Ralph@Pearson.com, for more
information).
Intervention
Cogmed© working memory training (Klingberg et al., 2005)
Study burden and risks
Risks will be considered minimal. Possible minor effects as headache or
sleeping problems will be assessed before, halfway and after the training
arthur van schendelstraat 631
3511 MZ
NL
arthur van schendelstraat 631
3511 MZ
NL
Listed location countries
Age
Inclusion criteria
- Children aged between 10 years/0 months and 13 years/11 months, 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).
- IQ score between 70 and 85 (BIF).
- Access to a PC with Windows Vista or Windows XP with internet connection and speakers (at home or school).
Exclusion criteria
- Currently intensive (i.e. weekly) individual or group psychotherapy.
- Regular use of other medication (stimulants / neuroleptics). When medication is used for ADHD, this isn*t a exclusion criteria in case of *room for improvement*.
- Diagnosis of one or more of the following comorbid psychiatric disorders:
o Major depression
o Bipolar disorder
o Psychotic disorder
o Chronically motor tic disorder or Gilles de la Tourette
o Conduct disorder
o Eating disorders
o Anxiety disorders
- 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 trail 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
In other registers
Register | ID |
---|---|
CCMO | NL32435.091.10 |
OMON | NL-OMON20558 |