Objective: 1) To investigate the efficacy of WM training in reducing behavioral symptoms in young children with ADHD.2) To investigate whether WM training improves neurocognitive functioning in young children with ADHD.3) To investigate whether WM…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint: ADHD-DSM-IV rating scale rated by the
investigator.
Secondary outcome
Neurocognitive functioning in young children with ADHD
Neural functioning in young children with ADHD
Background summary
Rationale: WM training has been shown to offer therapeutic benefits to patients
with ADHD in several studies, but methodological shortcomings indicate that
additional research is needed. This study is designed to examine the efficacy
of WM training in a scientific rigorously way in young ADHD children.
Study objective
Objective:
1) To investigate the efficacy of WM training in reducing behavioral symptoms
in young children with ADHD.
2) To investigate whether WM training improves neurocognitive functioning in
young children with ADHD.
3) To investigate whether WM training improves neural functioning in young
children with ADHD.
Study design
Double-blind randomised controlled treatment study.
Intervention
Intervention: 50 subjects receive 25 sessions WM training and 50 subjects
receive 25 sessions of the control version of WM training.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
Risks or side-effects are not expected. The burden for the subjects consists of
an intake, pre- and post-treatment assessments, the training itself consisting
of 25 sessions for 15 minutes, an evaluation and a follow-up. The intake,
pre-assessment, training and evaluation carry the same burden as treatment as
usual. The benefit involves of the a priori chance of positive effect of the WM
training on ADHD symptoms. Because ADHD is primarily a psychiatric disorder of
childhood, children will form the target population of the present study.
Reinier Postlaan 12, Karakter University Nijmegen
6525 GC Nijmegen
NL
Reinier Postlaan 12, Karakter University Nijmegen
6525 GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Age between 4 years/6 months and 7 years/4 months
Diagnosis ADHD, classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000)
A full scale IQ > 80 ;Psychopharmaca- naïve or -free;Access to a PC with Windows Vista or Windows XP with internet connection and speakers at home
Exclusion criteria
Currently intensive (i.e. weekly) individual or group psychotherapy
Regular use of other medication
Comorbid psychiatric disorders other than Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Neurological disorders (e.g. epilepsy) currently or in the past
Cardiovascular disease currently or in the past
Serious motor or perceptual handicap
Participation in another clinical trial simultaneously
Educational level and/ or socio-economic situation that makes it unlikely for the family to fulfil this study
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 | NL24290.091.08 |