Attention Deficit/Hyperactivity DisorderNCT02728011
Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD
A study testing Scientific Brain Training (SBT) and Tetris in people with Attention Deficit/Hyperactivity Disorder, run by Region Syddanmark at 2 sites in Denmark.
Trial summary
The purpose of this study was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Scientific Brain Training (SBT) and Tetris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2010to Dec 2011
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a clinical diagnosis of hyperkinetic disorder (F90.0, corresponding to ADHD combined type) (WHO, 1993);
- age between 14-17 years;
- IQ > 80.
Who cannot join
- pharmacological treatment other than methylphenidate, dexamphetamine and/or atomoxetine;
- comorbid conduct disorder, autism spectrum disorders or major depression;
- history of head trauma or verified neurological disease;
- motor or perceptual disabilities which prevented the use of a computer;
- medical illness that required treatment;
- no access to a computer and internet at home.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Child and Adolescent Mental Health Services Aabenraa
Aabenraa, 6200
Child and Adolescent Mental Health Services Augustenborg
Augustenborg, 6440
About this study
Official title: A Double-Blind Randomized Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With Attention-Deficit/Hyperactivity Disorder
The purpose of this study was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).
Read the detailed description
Objective: To examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).
Method: Eighteen adolescents with ADHD were randomized to treatment or control intervention for seven weeks. Outcome measures were cognitive test, symptom and motivation questionnaires.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Scientific Brain Training (SBT), Tetris
- 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.
Scientific Brain Training (SBT)Other
Cognitive training
TetrisOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Scientific Brain Training (SBT) Receives: Other: Scientific Brain Training (SBT) |
| Controle | Placebo comparator | Tetris Receives: Other: Tetris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Perception Questionnaire
Measured: 7 weeks
Secondary outcomes (4)
Attention Deficit/Hyperactivity Disorder-Rating Scale
Measured: 7 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)
Measured: 7 weeks
CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)
Measured: 7 weeks
CANTAB: DMS Delayed Matching to Sample (DMS)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Syddanmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Aida Bikic, Region Syddanmark
- Investigators
- Aida Bikic, MSc, Principal investigator, Region Syddanmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728011
- Sponsor's protocol ID
- 7/6/2010
- Status last verified
- Mar 2016
- First submitted
- 24 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02728011
- Acronym / sponsor ID
- 7/6/2010
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Region SyddanmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Apr 2016 (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 was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).
Detailed description
Objective: To examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).
Method: Eighteen adolescents with ADHD were randomized to treatment or control intervention for seven weeks. Outcome measures were cognitive test, symptom and motivation questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Scientific Brain Training (SBT)Scientific Brain Training (SBT) |
| Controle | Placebo comparator | Other: TetrisTetris |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a clinical diagnosis of hyperkinetic disorder (F90.0, corresponding to ADHD combined type) (WHO, 1993);
- age between 14-17 years;
- IQ > 80.
Key exclusion criteria (6 listed)
- pharmacological treatment other than methylphenidate, dexamphetamine and/or atomoxetine;
- comorbid conduct disorder, autism spectrum disorders or major depression;
- history of head trauma or verified neurological disease;
- motor or perceptual disabilities which prevented the use of a computer;
- medical illness that required 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 |
|---|---|---|
| Scientific Brain Training (SBT)Cognitive training | Other | Intervention |
| Tetris | Other | Controle |
Primary outcome
Activity Perception Questionnaire
Time frame: 7 weeks
4 secondary outcomes
Attention Deficit/Hyperactivity Disorder-Rating Scale
Time frame: 7 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)
Time frame: 7 weeks
CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)
Time frame: 7 weeks
CANTAB: DMS Delayed Matching to Sample (DMS)
Time frame: 7 weeks
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 5 Apr 2016.
- Individual participant dataSharing planned: Yes
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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, MSc principal investigator
Region Syddanmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scientific Brain Training (SBT) and Tetris in people with Attention Deficit/Hyperactivity Disorder, run by Region Syddanmark at 2 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 3 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Activity Perception Questionnaire (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2016.