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

This study is not yet open for participant recruitment.
Verified December 2012 by Region Syddanmark
Sponsor:
Information provided by (Responsible Party):
Aida Bikic, Region Syddanmark
ClinicalTrials.gov Identifier:
NCT01752530
First received: December 10, 2012
Last updated: December 14, 2012
Last verified: December 2012
  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 newly diagnosed, drug-naive 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: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Drug-naïve Children With ADHD.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: After the 8 week intervention ] [ Designated as safety issue: No ]
  • ADHD-Rating scale [ Time Frame: After the 8 week intervention ] [ Designated as safety issue: No ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: After the 8 week intervention ] [ Designated as safety issue: No ]
  • Clinical Global Improvement (CGI) [ Time Frame: After the 8 week intervention ] [ Designated as safety issue: No ]
  • Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • CANTAB: Match to sample: visual search. [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • CANTAB: Choice reaction time. [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: After the 8 week intervention ] [ Designated as safety issue: No ]
  • CANTAB: Stop Signal Task. [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • CANTAB: Spatial Working Memory [ Time Frame: After the 8 weeks of intervention ] [ Designated as safety issue: No ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: After the 8 weeks of intervention ] [ Designated as safety issue: No ]
  • CANTAB: Paired Associates Learning. [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Weis function scale [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • National Institutes of Health (NIH) test: Flanker [ Time Frame: After the 8 weeks of intervention ] [ Designated as safety issue: No ]
  • NIH: working memory [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • NIH: The dimensional change card sort (DCCS) [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • NIH: Go/No-go [ Time Frame: After the 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 12 weeks follow up ] [ Designated as safety issue: No ]
  • Behavior Rating Inventory of Executive Functions (BRIEF) [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • ADHD-Rating scale [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • ADHD-Rating scale [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Attention Switching Task (AST) [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • Clinical Global Improvement (CGI) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • Clinical Global Improvement (CGI) [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Match to sample: visual search. [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Choice reaction time. [ Time Frame: 12 weeks follow up ] [ Designated as safety issue: No ]
  • CANTAB: Choice reaction time. [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Affective Go/ No-go. [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Stop Signal Task. [ Time Frame: 12 weeks follow up ] [ Designated as safety issue: No ]
  • CANTAB: Stop Signal Task. [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Spatial Working Memory [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Spatial Working Memory [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 12 weeks follow up ] [ Designated as safety issue: No ]
  • CANTAB: Stockings of Cambridge. [ Time Frame: 24 weeks follow up ] [ Designated as safety issue: No ]
  • Weis function scale [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
  • Weis function scale [ Time Frame: 24 week follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (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 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ADHD- diagnosis
  2. age 6-12 years
  3. Patient has access to computer og internet from home
  4. Informed consent

Exclusion Criteria:

  1. receiving ADHD-medication before or at the point of recruitment
  2. Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
  3. Head trauma or neurological disease
  4. Intelligence quotient (IQ) < 80
  5. Motoric or perceptual handicap
  6. Medical disease requiring treatment
  7. No informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752530

Contacts
Contact: Aida Bikic, Ph.D stud. 0045 27577351 abikic@health.sdu.dk
Contact: Søren Dalsgaard, MD, Ph.D. 0045 24413787 sdalsgaard@health.sdu.dk

Locations
Denmark
Child and Adolescent Mental Health Services Aabenraa Not yet recruiting
Aabenraa, Denmark, 6200
Contact: Aida Bikic, Ph.D.stud    0045 27577351    abikic@health.sdu.dk   
Principal Investigator: Aida Bikic, Ph.D.stud.         
Sub-Investigator: James Leckman, professor         
Sub-Investigator: Torben Østergaard Christensen, Ph.D.         
Child and Adolescent Mental Health Services Augustenborg Not yet recruiting
Augustenborg, Denmark, 6440
Contact: Aida Bikic, Ph.D. student       abikic@health.sdu.dk   
Principal Investigator: Aida Bikic, Ph.D.stud.         
Child and Adolescent Mental Health Services Kolding Not yet recruiting
Kolding, Denmark, 6000
Contact: Aida Bikic, Ph.D student    0045 28994640    abikic@health.sdu.dk   
Principal Investigator: Aida Bikic, Ph.D. stud.         
Sponsors and Collaborators
Region Syddanmark
Investigators
Principal Investigator: Aida Bikic, Ph.D student Child and Adolescent Mental Health Services
Study Chair: Søren Dalsgaard, MD, Ph.D. Child and Adolescent Mental Health Services Odense, University of Southern Denmark.
  More Information

No publications provided

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: December 14, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Region Syddanmark:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014