Clinical trial NCT01752530: Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)
Official title: A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Children With ADHD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.
timeFrame: Assesment after the 8 week intervention
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Functions (BRIEF)
timeFrame: After the 8 week intervention
measure: ADHD-Rating scale
timeFrame: After the 8 week intervention
measure: CANTAB: Attention Switching Task (AST)
timeFrame: After the 8 week intervention
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing
timeFrame: After 8 weeks of intervention
Other outcomes:
measure: CANTAB: Match to sample: visual search.
timeFrame: After 8 weeks of intervention
measure: CANTAB: Choice reaction time.
timeFrame: After 8 weeks of intervention
measure: CANTAB: Stop Signal Task.
timeFrame: After 8 weeks of intervention
measure: CANTAB: Spatial Working Memory
timeFrame: After the 8 weeks of intervention
measure: CANTAB: Stockings of Cambridge.
timeFrame: After the 8 weeks of intervention
measure: CANTAB: Paired Associates Learning.
timeFrame: After 8 weeks of intervention
measure: Weis function scale
timeFrame: After 8 weeks of intervention
measure: Behavior Rating Inventory of Executive Functions (BRIEF)
timeFrame: 12 weeks follow up
measure: Behavior Rating Inventory of Executive Functions (BRIEF)
timeFrame: 24 week follow up
measure: ADHD-Rating scale
timeFrame: 12 week follow up
measure: ADHD-Rating scale
timeFrame: 24 week follow up
measure: CANTAB: Attention Switching Task (AST)
timeFrame: 12 week follow up
measure: CANTAB: Attention Switching Task (AST)
timeFrame: 24 week follow up
measure: CANTAB: Match to sample: visual search.
timeFrame: 12 week follow up
measure: CANTAB: Match to sample: visual search.
timeFrame: 24 week follow up
measure: CANTAB: Choice reaction time.
timeFrame: 12 weeks follow up
measure: CANTAB: Choice reaction time.
timeFrame: 24 week follow up
measure: CANTAB: Stop Signal Task.
timeFrame: 12 weeks follow up
measure: CANTAB: Stop Signal Task.
timeFrame: 24 week follow up
measure: CANTAB: Spatial Working Memory
timeFrame: 12 week follow up
measure: CANTAB: Spatial Working Memory
timeFrame: 24 week follow up
measure: CANTAB: Stockings of Cambridge.
timeFrame: 12 weeks follow up
measure: CANTAB: Stockings of Cambridge.
timeFrame: 24 weeks follow up
measure: Weis function scale
timeFrame: 12 week follow up
measure: Weis function scale
timeFrame: 24 week follow up
Locations:
city: Aabenraa
country: Denmark
facility: Child and Adolescent Mental Health Services Aabenraa
city: Augustenborg
country: Denmark
facility: Child and Adolescent Mental Health Services Augustenborg
city: Kolding
country: Denmark
facility: Child and Adolescent Mental Health Services Kolding
Study officials:
affiliation: Child and Adolescent Mental Health Services
name: Aida Bikic, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University
name: Søren Dalsgaard, MD, Ph.D.
role: STUDY_CHAIR
References:
citation: Bikic A, Leckman JF, Christensen TO, Bilenberg N, Dalsgaard S. Attention and executive functions computer training for attention-deficit/hyperactivity disorder (ADHD): results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2018 Dec;27(12):1563-1574. doi: 10.1007/s00787-018-1151-y. Epub 2018 Apr 11.
citation: Bikic A, Leckman JF, Lindschou J, Christensen TO, Dalsgaard S. Cognitive computer training in children with attention deficit hyperactivity disorder (ADHD) versus no intervention: study protocol for a randomized controlled trial. Trials. 2015 Oct 24;16:480. doi: 10.1186/s13063-015-0975-8.