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

April 26, 2017 updated by: Aida Bikic, Region Syddanmark

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.
Time Frame: Assesment after the 8 week intervention
Assesment after the 8 week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame: After the 8 week intervention
After the 8 week intervention
ADHD-Rating scale
Time Frame: After the 8 week intervention
After the 8 week intervention
CANTAB: Attention Switching Task (AST)
Time Frame: After the 8 week intervention
After the 8 week intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
CANTAB: Match to sample: visual search.
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention
CANTAB: Choice reaction time.
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention
CANTAB: Stop Signal Task.
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention
CANTAB: Spatial Working Memory
Time Frame: After the 8 weeks of intervention
After the 8 weeks of intervention
CANTAB: Stockings of Cambridge.
Time Frame: After the 8 weeks of intervention
After the 8 weeks of intervention
CANTAB: Paired Associates Learning.
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention
Weis function scale
Time Frame: After 8 weeks of intervention
After 8 weeks of intervention
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame: 12 weeks follow up
12 weeks follow up
Behavior Rating Inventory of Executive Functions (BRIEF)
Time Frame: 24 week follow up
24 week follow up
ADHD-Rating scale
Time Frame: 12 week follow up
12 week follow up
ADHD-Rating scale
Time Frame: 24 week follow up
24 week follow up
CANTAB: Attention Switching Task (AST)
Time Frame: 12 week follow up
12 week follow up
CANTAB: Attention Switching Task (AST)
Time Frame: 24 week follow up
24 week follow up
CANTAB: Match to sample: visual search.
Time Frame: 12 week follow up
12 week follow up
CANTAB: Match to sample: visual search.
Time Frame: 24 week follow up
24 week follow up
CANTAB: Choice reaction time.
Time Frame: 12 weeks follow up
12 weeks follow up
CANTAB: Choice reaction time.
Time Frame: 24 week follow up
24 week follow up
CANTAB: Stop Signal Task.
Time Frame: 12 weeks follow up
12 weeks follow up
CANTAB: Stop Signal Task.
Time Frame: 24 week follow up
24 week follow up
CANTAB: Spatial Working Memory
Time Frame: 12 week follow up
12 week follow up
CANTAB: Spatial Working Memory
Time Frame: 24 week follow up
24 week follow up
CANTAB: Stockings of Cambridge.
Time Frame: 12 weeks follow up
12 weeks follow up
CANTAB: Stockings of Cambridge.
Time Frame: 24 weeks follow up
24 weeks follow up
Weis function scale
Time Frame: 12 week follow up
12 week follow up
Weis function scale
Time Frame: 24 week follow up
24 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Syddanmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-20120096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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