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Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT01752530
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Aida Bikic, Region Syddanmark

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE December 19, 2012
Last Update Posted Date April 27, 2017
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit. [ Time Frame: Assesment after the 8 week intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: After the 8 week intervention ]
  • ADHD-Rating scale [ Time Frame: After the 8 week intervention ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: After the 8 week intervention ]
  • Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing [ Time Frame: After 8 weeks of intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: After the 8 week intervention ]
  • ADHD-Rating scale [ Time Frame: After the 8 week intervention ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: After the 8 week intervention ]
  • Clinical Global Improvement (CGI) [ Time Frame: After the 8 week intervention ]
  • Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing [ Time Frame: After 8 weeks of intervention ]
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2015)
  • CANTAB: Match to sample: visual search. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Choice reaction time. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Stop Signal Task. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Spatial Working Memory [ Time Frame: After the 8 weeks of intervention ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: After the 8 weeks of intervention ]
  • CANTAB: Paired Associates Learning. [ Time Frame: After 8 weeks of intervention ]
  • Weis function scale [ Time Frame: After 8 weeks of intervention ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 12 weeks follow up ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 24 week follow up ]
  • ADHD-Rating scale [ Time Frame: 12 week follow up ]
  • ADHD-Rating scale [ Time Frame: 24 week follow up ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 12 week follow up ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 24 week follow up ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 12 week follow up ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 24 week follow up ]
  • CANTAB: Choice reaction time. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Choice reaction time. [ Time Frame: 24 week follow up ]
  • CANTAB: Stop Signal Task. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Stop Signal Task. [ Time Frame: 24 week follow up ]
  • CANTAB: Spatial Working Memory [ Time Frame: 12 week follow up ]
  • CANTAB: Spatial Working Memory [ Time Frame: 24 week follow up ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 24 weeks follow up ]
  • Weis function scale [ Time Frame: 12 week follow up ]
  • Weis function scale [ Time Frame: 24 week follow up ]
Original Other Pre-specified Outcome Measures
 (submitted: December 14, 2012)
  • CANTAB: Match to sample: visual search. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Choice reaction time. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: After the 8 week intervention ]
  • CANTAB: Stop Signal Task. [ Time Frame: After 8 weeks of intervention ]
  • CANTAB: Spatial Working Memory [ Time Frame: After the 8 weeks of intervention ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: After the 8 weeks of intervention ]
  • CANTAB: Paired Associates Learning. [ Time Frame: After 8 weeks of intervention ]
  • Weis function scale [ Time Frame: After 8 weeks of intervention ]
  • National Institutes of Health (NIH) test: Flanker [ Time Frame: After the 8 weeks of intervention ]
  • NIH: working memory [ Time Frame: After 8 weeks of intervention ]
  • NIH: The dimensional change card sort (DCCS) [ Time Frame: After 8 weeks of intervention ]
  • NIH: Go/No-go [ Time Frame: After the 8 weeks of intervention ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 12 weeks follow up ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 24 week follow up ]
  • ADHD-Rating scale [ Time Frame: 12 week follow up ]
  • ADHD-Rating scale [ Time Frame: 24 week follow up ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 12 week follow up ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 24 week follow up ]
  • Clinical Global Improvement (CGI) [ Time Frame: 12 week follow up ]
  • Clinical Global Improvement (CGI) [ Time Frame: 24 week follow up ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 12 week follow up ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 24 week follow up ]
  • CANTAB: Choice reaction time. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Choice reaction time. [ Time Frame: 24 week follow up ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: 12 week follow up ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: 24 week follow up ]
  • CANTAB: Stop Signal Task. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Stop Signal Task. [ Time Frame: 24 week follow up ]
  • CANTAB: Spatial Working Memory [ Time Frame: 12 week follow up ]
  • CANTAB: Spatial Working Memory [ Time Frame: 24 week follow up ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 12 weeks follow up ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 24 weeks follow up ]
  • Weis function scale [ Time Frame: 12 week follow up ]
  • Weis function scale [ Time Frame: 24 week follow up ]
 
Descriptive Information
Brief Title  ICMJE Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Children With ADHD.
Brief Summary The purpose of this study is to determine the effect of computer program C8 on specific cognitive functions, symptoms and functional outcome compared to treatment as usual in children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training. In addition, it will be investigated, whether younger children benefit more from training than older children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Other: Computer program C8
    Experimental: Computer program C8 + treatment as usual: Playing a special computer program C8 40 min a day for 6 days a week for 8 weeks.
    Other Names:
    • C8
    • ADHD
    • Cognitive training
  • Other: Treatment as usual
    Treatment as usual at the clinic
    Other Name: TAU
Study Arms  ICMJE
  • Experimental: Computer program C8 + treatment as usual
    Computer program C 8 + treatment as usual. Subjects in the intervention group will be playing a special computer program C8 for 40 min a day, 6 times a week for 8 weeks in addition to treatment as usual.
    Interventions:
    • Other: Computer program C8
    • Other: Treatment as usual
  • Treatment as usual
    Treatment as usual at the clinic
    Intervention: Other: Treatment as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2012)
92
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ADHD- diagnosis
  2. age 6-13 years
  3. Patient has access to computer og internet from home
  4. Informed consent

Exclusion Criteria:

  1. Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
  2. Head trauma or neurological disease
  3. Intelligence quotient (IQ) < 80
  4. Motoric or perceptual handicap
  5. Medical disease requiring treatment
  6. No informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01752530
Other Study ID Numbers  ICMJE S-20120096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aida Bikic, Region Syddanmark
Study Sponsor  ICMJE Region Syddanmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aida Bikic, Ph.D Child and Adolescent Mental Health Services
Study Chair: Søren Dalsgaard, MD, Ph.D. Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University
PRS Account Region Syddanmark
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP