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Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD

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ClinicalTrials.gov Identifier: NCT02728011
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
Region of Southern Denmark
Information provided by (Responsible Party):
Aida Bikic, Region Syddanmark

Brief 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).

Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Other: Scientific Brain Training (SBT) Other: Tetris Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With Attention-Deficit/Hyperactivity Disorder
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: Intervention
Scientific Brain Training (SBT)
Other: Scientific Brain Training (SBT)
Cognitive training

Placebo Comparator: Controle
Tetris
Other: Tetris



Primary Outcome Measures :
  1. Activity Perception Questionnaire [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Attention Deficit/Hyperactivity Disorder-Rating Scale [ Time Frame: 7 weeks ]
  2. Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A) [ Time Frame: 7 weeks ]
  3. CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves) [ Time Frame: 7 weeks ]
  4. CANTAB: DMS Delayed Matching to Sample (DMS) [ Time Frame: 7 weeks ]

Other Outcome Measures:
  1. CANTAB: Spatial Span (SSP) [ Time Frame: 7 weeks ]
  2. CANTAB: Intra-Extra Dimensional Set Shift (IED) [ Time Frame: 7 weeks ]
  3. CANTAB: Spatial Working Memory (SWM) [ Time Frame: 7 weeks ]
  4. Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Probability of hit [ Time Frame: 7 weeks ]


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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. a clinical diagnosis of hyperkinetic disorder (F90.0, corresponding to ADHD combined type) (WHO, 1993);
  2. age between 14-17 years;
  3. IQ > 80.

Exclusion Criteria:

  1. pharmacological treatment other than methylphenidate, dexamphetamine and/or atomoxetine;
  2. comorbid conduct disorder, autism spectrum disorders or major depression;
  3. history of head trauma or verified neurological disease;
  4. motor or perceptual disabilities which prevented the use of a computer;
  5. medical illness that required treatment;
  6. no access to a computer and internet at home.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728011


Locations
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Denmark
Child and Adolescent Mental Health Services Aabenraa
Aabenraa, Denmark, 6200
Child and Adolescent Mental Health Services Augustenborg
Augustenborg, Denmark, 6440
Sponsors and Collaborators
Region Syddanmark
Region of Southern Denmark
Investigators
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Principal Investigator: Aida Bikic, MSc Region Syddanmark
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Responsible Party: Aida Bikic, psychologist, ph.d. candidate, Region Syddanmark
ClinicalTrials.gov Identifier: NCT02728011    
Other Study ID Numbers: 7/6/2010
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases