NCT00819611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

3.9 years

First QC Date

January 8, 2009

Last Update Submit

January 9, 2014

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention deficit disorder with hyperactivityWorking memory trainingPlaceboBehavioral symptomsNeuropsychologyElectropsychophysiology

Outcome Measures

Primary Outcomes (1)

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

    7 weeks

Secondary Outcomes (1)

  • Neurocognitive performance and electrocortical activity

    7 weeks

Study Arms (2)

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

Cogmed Working memory trainingBEHAVIORAL

15 minutes of working memory training, 5 days a week for a period of 5 weeks

Working memory training
Control version of Cogmed working memory trainingBEHAVIORAL

15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks

Control version of working memory training

Eligibility Criteria

Age54 Months - 88 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karakter University Centre for Child and Adolescent Psychiatry Nijmegen

Nijmegen, 6525 GC, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 15689731BACKGROUND

  • 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.

    PMID: 24628438DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityBehavioral Symptoms

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Dorine Slaats-Willemse, PhD

    Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

NL(1)