Clinical trial NCT02728011: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2016-04-05
Enrollment: 18
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Activity Perception Questionnaire
timeFrame: 7 weeks
Secondary outcomes:
measure: Attention Deficit/Hyperactivity Disorder-Rating Scale
timeFrame: 7 weeks
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVP)(A)
timeFrame: 7 weeks
measure: CANTAB: Stockings of Cambridge (SOC) (problems solved in minimum moves)
timeFrame: 7 weeks
measure: CANTAB: DMS Delayed Matching to Sample (DMS)
timeFrame: 7 weeks
Other outcomes:
measure: CANTAB: Spatial Span (SSP)
timeFrame: 7 weeks
measure: CANTAB: Intra-Extra Dimensional Set Shift (IED)
timeFrame: 7 weeks
measure: CANTAB: Spatial Working Memory (SWM)
timeFrame: 7 weeks
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Probability of hit
timeFrame: 7 weeks
Locations:
city: Aabenraa
country: Denmark
facility: Child and Adolescent Mental Health Services Aabenraa
city: Augustenborg
country: Denmark
facility: Child and Adolescent Mental Health Services Augustenborg
Study officials:
affiliation: Region Syddanmark
name: Aida Bikic, MSc
role: PRINCIPAL_INVESTIGATOR
References: