Working Memory Training in Young ADHD Children

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819611
• Other study ID #: WM01022009
• Secondary ID: RN000142
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2009
• Last updated: January 9, 2014
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether working memory training improves behavioral symptoms, neurocognitive performance, and neural functioning in young children with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 54 Months to 88 Months

Eligibility

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 medication

• Diagnosis of one or more of the following comorbid psychiatric disorders: Major depression, Bipolar disorder, Psychotic disorder, Chronically motor tic disorder or Gilles de la Tourette, Conduct disorder, any other autism spectrum disorder except for Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Eating disorders, Anxiety disorders

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Cogmed Working memory training
15 minutes of working memory training, 5 days a week for a period of 5 weeks
• Control version of Cogmed working memory training
15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks

Locations

Country	Name	City	State
Netherlands	Karakter University Centre for Child and Adolescent Psychiatry Nijmegen	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlström K, Gillberg CG, Forssberg H, Westerberg H. Computerized training of working memory in children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2005 Feb;44(2):177-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD criteria according to the DSM-IV-TR rated by the investigator		7 weeks	No
Secondary	Neurocognitive performance and electrocortical activity		7 weeks	No