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

Primary Purpose

ADHD

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Computer program C8
Treatment as usual
Sponsored by
Region Syddanmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Child and Adolescent Mental Health Services Aabenraa
  • Child and Adolescent Mental Health Services Augustenborg
  • Child and Adolescent Mental Health Services Kolding

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Computer program C8 + treatment as usual

Treatment as usual

Arm Description

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.

Treatment as usual at the clinic

Outcomes

Primary Outcome Measures

Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.

Secondary Outcome Measures

Behavior Rating Inventory of Executive Functions (BRIEF)
ADHD-Rating scale
CANTAB: Attention Switching Task (AST)
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing

Full Information

First Posted
December 10, 2012
Last Updated
April 26, 2017
Sponsor
Region Syddanmark
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1. Study Identification

Unique Protocol Identification Number
NCT01752530
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Syddanmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer program C8 + treatment as usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Treatment as usual at the clinic
Intervention Type
Other
Intervention Name(s)
Computer program C8
Other Intervention Name(s)
C8, ADHD, Cognitive training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
Treatment as usual at the clinic
Primary Outcome Measure Information:
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.
Time Frame
Assesment after the 8 week intervention
Secondary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame
After the 8 week intervention
Title
ADHD-Rating scale
Time Frame
After the 8 week intervention
Title
CANTAB: Attention Switching Task (AST)
Time Frame
After the 8 week intervention
Title
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing
Time Frame
After 8 weeks of intervention
Other Pre-specified Outcome Measures:
Title
CANTAB: Match to sample: visual search.
Time Frame
After 8 weeks of intervention
Title
CANTAB: Choice reaction time.
Time Frame
After 8 weeks of intervention
Title
CANTAB: Stop Signal Task.
Time Frame
After 8 weeks of intervention
Title
CANTAB: Spatial Working Memory
Time Frame
After the 8 weeks of intervention
Title
CANTAB: Stockings of Cambridge.
Time Frame
After the 8 weeks of intervention
Title
CANTAB: Paired Associates Learning.
Time Frame
After 8 weeks of intervention
Title
Weis function scale
Time Frame
After 8 weeks of intervention
Title
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame
12 weeks follow up
Title
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame
24 week follow up
Title
ADHD-Rating scale
Time Frame
12 week follow up
Title
ADHD-Rating scale
Time Frame
24 week follow up
Title
CANTAB: Attention Switching Task (AST)
Time Frame
12 week follow up
Title
CANTAB: Attention Switching Task (AST)
Time Frame
24 week follow up
Title
CANTAB: Match to sample: visual search.
Time Frame
12 week follow up
Title
CANTAB: Match to sample: visual search.
Time Frame
24 week follow up
Title
CANTAB: Choice reaction time.
Time Frame
12 weeks follow up
Title
CANTAB: Choice reaction time.
Time Frame
24 week follow up
Title
CANTAB: Stop Signal Task.
Time Frame
12 weeks follow up
Title
CANTAB: Stop Signal Task.
Time Frame
24 week follow up
Title
CANTAB: Spatial Working Memory
Time Frame
12 week follow up
Title
CANTAB: Spatial Working Memory
Time Frame
24 week follow up
Title
CANTAB: Stockings of Cambridge.
Time Frame
12 weeks follow up
Title
CANTAB: Stockings of Cambridge.
Time Frame
24 weeks follow up
Title
Weis function scale
Time Frame
12 week follow up
Title
Weis function scale
Time Frame
24 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD- diagnosis age 6-13 years Patient has access to computer og internet from home Informed consent Exclusion Criteria: Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia Head trauma or neurological disease Intelligence quotient (IQ) < 80 Motoric or perceptual handicap Medical disease requiring treatment No informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida Bikic, Ph.D
Organizational Affiliation
Child and Adolescent Mental Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Søren Dalsgaard, MD, Ph.D.
Organizational Affiliation
Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University
Official's Role
Study Chair
Facility Information:
Facility Name
Child and Adolescent Mental Health Services Aabenraa
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Facility Name
Child and Adolescent Mental Health Services Augustenborg
City
Augustenborg
ZIP/Postal Code
6440
Country
Denmark
Facility Name
Child and Adolescent Mental Health Services Kolding
City
Kolding
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29644473
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.
Results Reference
derived
PubMed Identifier
26499057
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.
Results Reference
derived

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

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