ADHDNCT01752530
Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)
A study testing Computer program C8 and Treatment as usual in people with ADHD, run by Region Syddanmark at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Computer program C8 and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesDenmark
- Study dates
- Feb 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD- diagnosis
- age 6-13 years
- Patient has access to computer og internet from home
- Informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Child and Adolescent Mental Health Services Aabenraa
Aabenraa, 6200
Child and Adolescent Mental Health Services Augustenborg
Augustenborg, 6440
Child and Adolescent Mental Health Services Kolding
Kolding, 6000
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Computer program C8, Treatment as usual
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer program C8Other
Also called C8, ADHD, Cognitive training
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.
Treatment as usualOther
Also called TAU
Treatment as usual at the clinic
| Study group | Role | What they receive |
|---|---|---|
| Computer program C8 + treatment as usual | Experimental | 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. Receives: Other: Computer program C8; Other: Treatment as usual |
| Treatment as usual | Other | Treatment as usual at the clinic Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.
Measured: Assesment after the 8 week intervention
Secondary outcomes (4)
Behavior Rating Inventory of Executive Functions (BRIEF)
Measured: After the 8 week intervention
ADHD-Rating scale
Measured: After the 8 week intervention
CANTAB: Attention Switching Task (AST)
Measured: After the 8 week intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing
Measured: After 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionOct 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Syddanmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Bikic, Region Syddanmark
- Investigators
- Aida Bikic, Ph.D, Principal investigator, Child and Adolescent Mental Health ServicesSøren Dalsgaard, MD, Ph.D., Study chair, Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752530
- Sponsor's protocol ID
- S-20120096
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 2012
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29644473Bikic 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.
PubMed 26499057
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Computerized Cognitive Training on Cognitive Function, Symptoms and Functional Outcome in Children With ADHD.
- ClinicalTrials.gov ID
- NCT01752530
- Acronym / sponsor ID
- S-20120096
- Conditions
- ADHD
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Region SyddanmarkUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer program C8 + treatment as usual | Experimental | Other: Computer program C8, Other: Treatment as usualComputer 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 | Other | Other: Treatment as usualTreatment as usual at the clinic |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ADHD- diagnosis
- age 6-13 years
- Patient has access to computer og internet from home
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer program C8Also: C8, ADHD, Cognitive trainingExperimental: 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 | Computer program C8 + treatment as usual |
| Treatment as usualAlso: TAUTreatment as usual at the clinic | Other | Computer program C8 + treatment as usual, Treatment as usual |
Primary outcome
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.
Time frame: Assesment after the 8 week intervention
4 secondary outcomes
Behavior Rating Inventory of Executive Functions (BRIEF)
Time frame: After the 8 week intervention
ADHD-Rating scale
Time frame: After the 8 week intervention
CANTAB: Attention Switching Task (AST)
Time frame: After the 8 week intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing
Time frame: After 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 29644473Bikic 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.
- Derived from this study: PubMed 26499057Bikic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida Bikic, Ph.D principal investigator
Child and Adolescent Mental Health Services
Søren Dalsgaard, MD, Ph.D. study chair
Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer program C8 and Treatment as usual in people with ADHD, run by Region Syddanmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit. (time frame: Assesment after the 8 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.