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

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).

Study Overview

• Status: Completed
• Conditions: Attention Deficit/Hyperactivity Disorder
• Intervention / Treatment: Other: Scientific Brain Training (SBT); Other: Tetris

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Child and Adolescent Mental Health Services Aabenraa
  • Augustenborg, Denmark, 6440
    • Child and Adolescent Mental Health Services Augustenborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Scientific Brain Training (SBT)	Other: Scientific Brain Training (SBT); Cognitive training
PLACEBO_COMPARATOR: Controle; Tetris	Other: Tetris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity Perception Questionnaire	7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
CANTAB: Spatial Span (SSP)	7 weeks
CANTAB: Intra-Extra Dimensional Set Shift (IED)	7 weeks
CANTAB: Spatial Working Memory (SWM)	7 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Probability of hit	7 weeks

Collaborators and Investigators

• Sponsor: Region Syddanmark
• Collaborators: Region of Southern Denmark
• Investigators: Principal Investigator: Aida Bikic, MSc, Region Syddanmark

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (ESTIMATE): April 5, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 7/6/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES