Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aida Bikic, Region Syddanmark
ClinicalTrials.gov Identifier:
NCT01752530
First received: December 10, 2012
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
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 Intervention
ADHD
Other: Computer program C8
Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Region Syddanmark:

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

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 70
Actual Study Start Date: February 2013
Study Completion Date: September 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752530

Locations
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aida Bikic, psychologist, Ph.D. student, Region Syddanmark
ClinicalTrials.gov Identifier: NCT01752530     History of Changes
Other Study ID Numbers: S-20120096
Study First Received: December 10, 2012
Last Updated: April 26, 2017

Keywords provided by Region Syddanmark:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 25, 2017