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

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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Other: Computer program C8; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Child and Adolescent Mental Health Services Aabenraa
  • Augustenborg, Denmark, 6440
    • Child and Adolescent Mental Health Services Augustenborg
  • Kolding, Denmark, 6000
    • Child and Adolescent Mental Health Services Kolding

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Cognitive training; C8; ADHD; Other: Treatment as usual; Treatment as usual at the clinic; Other Names: TAU
Other: Treatment as usual; Treatment as usual at the clinic	Other: Treatment as usual; Treatment as usual at the clinic; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Behavior Rating Inventory of Executive Functions (BRIEF)	After the 8 week intervention
ADHD-Rating scale	After the 8 week intervention
CANTAB: Attention Switching Task (AST)	After the 8 week intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing	After 8 weeks of intervention

Other Outcome Measures

Outcome Measure	Time Frame
CANTAB: Match to sample: visual search.	After 8 weeks of intervention
CANTAB: Choice reaction time.	After 8 weeks of intervention
CANTAB: Stop Signal Task.	After 8 weeks of intervention
CANTAB: Spatial Working Memory	After the 8 weeks of intervention
CANTAB: Stockings of Cambridge.	After the 8 weeks of intervention
CANTAB: Paired Associates Learning.	After 8 weeks of intervention
Weis function scale	After 8 weeks of intervention
Behavior Rating Inventory of Executive Functions (BRIEF)	12 weeks follow up
Behavior Rating Inventory of Executive Functions (BRIEF)	24 week follow up
ADHD-Rating scale	12 week follow up
ADHD-Rating scale	24 week follow up
CANTAB: Attention Switching Task (AST)	12 week follow up
CANTAB: Attention Switching Task (AST)	24 week follow up
CANTAB: Match to sample: visual search.	12 week follow up
CANTAB: Match to sample: visual search.	24 week follow up
CANTAB: Choice reaction time.	12 weeks follow up
CANTAB: Choice reaction time.	24 week follow up
CANTAB: Stop Signal Task.	12 weeks follow up
CANTAB: Stop Signal Task.	24 week follow up
CANTAB: Spatial Working Memory	12 week follow up
CANTAB: Spatial Working Memory	24 week follow up
CANTAB: Stockings of Cambridge.	12 weeks follow up
CANTAB: Stockings of Cambridge.	24 weeks follow up
Weis function scale	12 week follow up
Weis function scale	24 week follow up

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ADHD
• Other Study ID Numbers: S-20120096