Working Memory Training in Young ADHD Children | NCT00819611

Studies
Working Memory Training in Young ADHD Children

NCT00819611

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Jan 10, 2014Estimated

Enrollment

51Actual

Phase

Phase 4

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Cogmed Working memory training
Control version of Cogmed working memory training

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RN000142

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

May 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2014

Last Update Posted Date

Jan 10, 2014Estimated

Name	Class
Netherlands Organisation for Scientific Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Working memory training	Experimental		Behavioral: Cogmed Working memory training
Control version of working memory training	Sham Comparator		Behavioral: Control version of Cogmed working memory training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cogmed Working memory training	Behavioral	15 minutes of working memory training, 5 days a week for a period of 5 weeks	Working memory training

Measure	Description	Time Frame
ADHD criteria according to the DSM-IV-TR rated by the investigator		7 weeks

Measure	Description	Time Frame
Neurocognitive performance and electrocortical activity		7 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

54 Months

Maximum Age

88 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dorine Slaats-Willemse, PhD	Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karakter University Centre for Child and Adolescent Psychiatry Nijmegen		Nijmegen		6525 GC	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15689731	Background	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.
24628438	Derived

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D001526	Behavioral Symptoms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D001519	Behavior