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

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Scientific Brain Training (SBT)

Tetris

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Child and Adolescent Mental Health Services Aabenraa
Child and Adolescent Mental Health Services Augustenborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Controle

Arm Description

Scientific Brain Training (SBT)

Tetris

Outcomes

Primary Outcome Measures

Activity Perception Questionnaire

Secondary Outcome Measures

Attention Deficit/Hyperactivity Disorder-Rating Scale

Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)

CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)

CANTAB: DMS Delayed Matching to Sample (DMS)

Full Information

NCT ID

NCT02728011

First Posted

March 24, 2016

Last Updated

April 4, 2016

Sponsor

Region Syddanmark

Collaborators

Region of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02728011

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Syddanmark

Collaborators

Region of Southern Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Scientific Brain Training (SBT)

Arm Title

Controle

Arm Type

Placebo Comparator

Arm Description

Tetris

Intervention Type

Other

Intervention Name(s)

Scientific Brain Training (SBT)

Intervention Description

Cognitive training

Intervention Type

Other

Intervention Name(s)

Tetris

Primary Outcome Measure Information:

Title

Activity Perception Questionnaire

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Attention Deficit/Hyperactivity Disorder-Rating Scale

Time Frame

7 weeks

Title

Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)

Time Frame

7 weeks

Title

CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)

Time Frame

7 weeks

Title

CANTAB: DMS Delayed Matching to Sample (DMS)

Time Frame

7 weeks

Other Pre-specified Outcome Measures:

Title

CANTAB: Spatial Span (SSP)

Time Frame

7 weeks

Title

CANTAB: Intra-Extra Dimensional Set Shift (IED)

Time Frame

7 weeks

Title

CANTAB: Spatial Working Memory (SWM)

Time Frame

7 weeks

Title

Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Probability of hit

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aida Bikic, MSc

Organizational Affiliation

Region Syddanmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Child and Adolescent Mental Health Services Aabenraa

City

Aabenraa

ZIP/Postal Code

6200

Country

Denmark

Facility Name

Child and Adolescent Mental Health Services Augustenborg

City

Augustenborg

ZIP/Postal Code

6440

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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