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Trial record 1 of 1 for:    NCT01752530
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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Other: Computer program C8 Other: Treatment as usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Children With ADHD.
Actual Study Start Date : February 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
Treatment as usual
Treatment as usual at the clinic
 Other: Treatment as usual
Treatment as usual at the clinic
Other Name: TAU


Outcome Measures
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Primary Outcome Measures :
  1. Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit. [ Time Frame: Assesment after the 8 week intervention ]

Secondary Outcome Measures :
  1. Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: After the 8 week intervention ]
  2. ADHD-Rating scale [ Time Frame: After the 8 week intervention ]
  3. CANTAB: Attention Switching Task (AST) [ Time Frame: After the 8 week intervention ]
  4. Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing [ Time Frame: After 8 weeks of intervention ]

Other Outcome Measures:
  1. CANTAB: Match to sample: visual search. [ Time Frame: After 8 weeks of intervention ]
  2. CANTAB: Choice reaction time. [ Time Frame: After 8 weeks of intervention ]
  3. CANTAB: Stop Signal Task. [ Time Frame: After 8 weeks of intervention ]
  4. CANTAB: Spatial Working Memory [ Time Frame: After the 8 weeks of intervention ]
  5. CANTAB: Stockings of Cambridge. [ Time Frame: After the 8 weeks of intervention ]
  6. CANTAB: Paired Associates Learning. [ Time Frame: After 8 weeks of intervention ]
  7. Weis function scale [ Time Frame: After 8 weeks of intervention ]
  8. Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 12 weeks follow up ]
  9. Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 24 week follow up ]
  10. ADHD-Rating scale [ Time Frame: 12 week follow up ]
  11. ADHD-Rating scale [ Time Frame: 24 week follow up ]
  12. CANTAB: Attention Switching Task (AST) [ Time Frame: 12 week follow up ]
  13. CANTAB: Attention Switching Task (AST) [ Time Frame: 24 week follow up ]
  14. CANTAB: Match to sample: visual search. [ Time Frame: 12 week follow up ]
  15. CANTAB: Match to sample: visual search. [ Time Frame: 24 week follow up ]
  16. CANTAB: Choice reaction time. [ Time Frame: 12 weeks follow up ]
  17. CANTAB: Choice reaction time. [ Time Frame: 24 week follow up ]
  18. CANTAB: Stop Signal Task. [ Time Frame: 12 weeks follow up ]
  19. CANTAB: Stop Signal Task. [ Time Frame: 24 week follow up ]
  20. CANTAB: Spatial Working Memory [ Time Frame: 12 week follow up ]
  21. CANTAB: Spatial Working Memory [ Time Frame: 24 week follow up ]
  22. CANTAB: Stockings of Cambridge. [ Time Frame: 12 weeks follow up ]
  23. CANTAB: Stockings of Cambridge. [ Time Frame: 24 weeks follow up ]
  24. Weis function scale [ Time Frame: 12 week follow up ]
  25. Weis function scale [ Time Frame: 24 week follow up ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752530


Locations
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Denmark
Child and Adolescent Mental Health Services Aabenraa
Aabenraa, Denmark, 6200
Child and Adolescent Mental Health Services Augustenborg
Augustenborg, Denmark, 6440
Child and Adolescent Mental Health Services Kolding
Kolding, Denmark, 6000
Sponsors and Collaborators
Region Syddanmark
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aida Bikic, psychologist, Ph.D. student, Region Syddanmark
ClinicalTrials.gov Identifier: NCT01752530    
Other Study ID Numbers: S-20120096
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by Aida Bikic, Region Syddanmark:
ADHD