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

April 4, 2016 updated by: Aida Bikic, Region Syddanmark

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Syddanmark

Collaborators

Region of Southern Denmark

Investigators

  • Principal Investigator: Aida Bikic, MSc, Region Syddanmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 7/6/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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