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Working Memory Training in Young ADHD Children

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Cogmed Working memory training
Control version of Cogmed working memory training
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention deficit disorder with hyperactivity, Working memory training, Placebo, Behavioral symptoms, Neuropsychology, Electropsychophysiology

Eligibility Criteria

54 Months - 88 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karakter University Centre for Child and Adolescent Psychiatry Nijmegen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Working memory training

Control version of working memory training

Arm Description

Outcomes

Primary Outcome Measures

ADHD criteria according to the DSM-IV-TR rated by the investigator

Secondary Outcome Measures

Neurocognitive performance and electrocortical activity

Full Information

First Posted
January 8, 2009
Last Updated
January 9, 2014
Sponsor
Radboud University Medical Center
Collaborators
Netherlands Organisation for Scientific Research
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1. Study Identification

Unique Protocol Identification Number
NCT00819611
Brief Title
Working Memory Training in Young ADHD Children
Official Title
Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
Netherlands Organisation for Scientific Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention deficit disorder with hyperactivity, Working memory training, Placebo, Behavioral symptoms, Neuropsychology, Electropsychophysiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Experimental
Arm Title
Control version of working memory training
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cogmed Working memory training
Intervention Description
15 minutes of working memory training, 5 days a week for a period of 5 weeks
Intervention Type
Behavioral
Intervention Name(s)
Control version of Cogmed working memory training
Intervention Description
15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks
Primary Outcome Measure Information:
Title
ADHD criteria according to the DSM-IV-TR rated by the investigator
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Neurocognitive performance and electrocortical activity
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
54 Months
Maximum Age & Unit of Time
88 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorine Slaats-Willemse, PhD
Organizational Affiliation
Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karakter University Centre for Child and Adolescent Psychiatry Nijmegen
City
Nijmegen
ZIP/Postal Code
6525 GC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15689731
Citation
Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlstrom 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. doi: 10.1097/00004583-200502000-00010.
Results Reference
background
PubMed Identifier
24628438
Citation
van Dongen-Boomsma M, Vollebregt MA, Buitelaar JK, Slaats-Willemse D. Working memory training in young children with ADHD: a randomized placebo-controlled trial. J Child Psychol Psychiatry. 2014 Aug;55(8):886-96. doi: 10.1111/jcpp.12218. Epub 2014 Mar 15.
Results Reference
derived

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Working Memory Training in Young ADHD Children

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