Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD
A Double-Blind Randomized Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With Attention-Deficit/Hyperactivity Disorder
1 other identifier
interventional
18
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedApril 5, 2016
March 1, 2016
2 months
March 24, 2016
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Activity Perception Questionnaire
7 weeks
Secondary Outcomes (4)
Attention Deficit/Hyperactivity Disorder-Rating Scale
7 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)
7 weeks
CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)
7 weeks
CANTAB: DMS Delayed Matching to Sample (DMS)
7 weeks
Other Outcomes (4)
CANTAB: Spatial Span (SSP)
7 weeks
CANTAB: Intra-Extra Dimensional Set Shift (IED)
7 weeks
CANTAB: Spatial Working Memory (SWM)
7 weeks
- +1 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALScientific Brain Training (SBT)
Controle
PLACEBO COMPARATORTetris
Interventions
Eligibility Criteria
You may qualify if:
- a clinical diagnosis of hyperkinetic disorder (F90.0, corresponding to ADHD combined type) (WHO, 1993);
- age between 14-17 years;
- IQ \> 80.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Syddanmarklead
- Region of Southern Denmarkcollaborator
Study Sites (2)
Child and Adolescent Mental Health Services Aabenraa
Aabenraa, 6200, Denmark
Child and Adolescent Mental Health Services Augustenborg
Augustenborg, 6440, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aida Bikic, MSc
Region Syddanmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- psychologist, ph.d. candidate
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 5, 2016
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
April 5, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share