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

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Double-Blind Randomized Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728011
• Other study ID #: 7/6/2010
• Status: Completed
• Phase: N/A
• First received: March 24, 2016
• Last updated: April 4, 2016
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2016
• Source: Region Syddanmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Danish Data Protection Agency, Denmark':'
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• Scientific Brain Training (SBT)
Cognitive training
• Tetris

Locations

Country	Name	City	State
Denmark	Child and Adolescent Mental Health Services Aabenraa	Aabenraa
Denmark	Child and Adolescent Mental Health Services Augustenborg	Augustenborg

Sponsors (2)

Lead Sponsor	Collaborator
Region Syddanmark	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CANTAB: Spatial Span (SSP)		7 weeks	No
Other	CANTAB: Intra-Extra Dimensional Set Shift (IED)		7 weeks	No
Other	CANTAB: Spatial Working Memory (SWM)		7 weeks	No
Other	Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Probability of hit		7 weeks	No
Primary	Activity Perception Questionnaire		7 weeks	No
Secondary	Attention Deficit/Hyperactivity Disorder-Rating Scale		7 weeks	No
Secondary	Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)		7 weeks	No
Secondary	CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)		7 weeks	No
Secondary	CANTAB: DMS Delayed Matching to Sample (DMS)		7 weeks	No