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Completed

NCT Number: NCT01752530

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Mental Health Services Aabenraa, Aabenraa, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD- diagnosis
  • age 6-13 years
  • Patient has access to computer og internet from home
  • Informed consent

Exclusion criteria

  • Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
  • Head trauma or neurological disease
  • Intelligence quotient (IQ) < 80
  • Motoric or perceptual handicap
  • Medical disease requiring treatment
  • No informed consent

Treatment and study plan

Computer program C8

Other

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

Treatment as Usual

Other

Treatment as usual at the clinic

Other names: TAU

Primary outcomes

  1. Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.

    Time frame: Assesment after the 8 week intervention

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Syddanmark

Other

Registry information

Official study title

A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Children With ADHD.

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 19, 2012
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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