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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01752530
Other study ID # S-20120096
Secondary ID
Status Completed
Phase N/A
First received December 10, 2012
Last updated April 26, 2017
Start date February 2013
Est. completion date September 2016

Study information

Verified date April 2017
Source Region Syddanmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 6 Years to 13 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity

Intervention

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.
Treatment as usual
Treatment as usual at the clinic

Locations

Country Name City State
Denmark Child and Adolescent Mental Health Services Aabenraa Aabenraa
Denmark Child and Adolescent Mental Health Services Augustenborg Augustenborg
Denmark Child and Adolescent Mental Health Services Kolding Kolding

Sponsors (1)

Lead Sponsor Collaborator
Region Syddanmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other CANTAB: Match to sample: visual search. After 8 weeks of intervention
Other CANTAB: Choice reaction time. After 8 weeks of intervention
Other CANTAB: Stop Signal Task. After 8 weeks of intervention
Other CANTAB: Spatial Working Memory After the 8 weeks of intervention
Other CANTAB: Stockings of Cambridge. After the 8 weeks of intervention
Other CANTAB: Paired Associates Learning. After 8 weeks of intervention
Other Weis function scale After 8 weeks of intervention
Other Behavior Rating Inventory of Executive Functions (BRIEF) 12 weeks follow up
Other Behavior Rating Inventory of Executive Functions (BRIEF) 24 week follow up
Other ADHD-Rating scale 12 week follow up
Other ADHD-Rating scale 24 week follow up
Other CANTAB: Attention Switching Task (AST) 12 week follow up
Other CANTAB: Attention Switching Task (AST) 24 week follow up
Other CANTAB: Match to sample: visual search. 12 week follow up
Other CANTAB: Match to sample: visual search. 24 week follow up
Other CANTAB: Choice reaction time. 12 weeks follow up
Other CANTAB: Choice reaction time. 24 week follow up
Other CANTAB: Stop Signal Task. 12 weeks follow up
Other CANTAB: Stop Signal Task. 24 week follow up
Other CANTAB: Spatial Working Memory 12 week follow up
Other CANTAB: Spatial Working Memory 24 week follow up
Other CANTAB: Stockings of Cambridge. 12 weeks follow up
Other CANTAB: Stockings of Cambridge. 24 weeks follow up
Other Weis function scale 12 week follow up
Other Weis function scale 24 week follow up
Primary Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit. Assesment after the 8 week intervention
Secondary Behavior Rating Inventory of Executive Functions (BRIEF) After the 8 week intervention
Secondary ADHD-Rating scale After the 8 week intervention
Secondary CANTAB: Attention Switching Task (AST) After the 8 week intervention
Secondary Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing After 8 weeks of intervention
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