The objective of the current study is to evaluate QbTest on a smartphone (QbMT), in terms of: 1. The feasibility of QbMT as a smartphone software that incorporates the Quantified behavioral Test (QbTest *)2. The validity of QbMT in individuals…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The QbMT feasibility examination will involve as a primary objective, the
examination of the data flow in the use of QbMT to identify potential errors or
technical issues that may be associated with the data collection and QbTest
parameter calculation. We will further examine the validity of QbMT in
individuals diagnosed with ADHD. All the available QbTest measures of activity,
impulsivity, and attention will be included as measures of interest in this
study. These are described in the *Measures* section of the protocol.
Secondary outcome
The secondary objective of the QbMT study is to explore additional eye-movement
variables and parameters that can be calculated from a mobile camera device and
the mobile use of QbTest such as indices of activity, attention, and
impulsivity, and compare this with individuals with and without ADHD.
Background summary
QbTest is a computer-administered test that objectively measures the three
cardinal symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD);
inattention, hyperactivity, and impulsivity. The implementation of QbTest in
the clinical setting has been shown to improve the efficiency,
cost-effectiveness, and accuracy of the diagnostic process.
Recent reviews emphasize the need to further examine technology-based tools in
the assessment and treatment evaluation of ADHD by objective monitoring and
quantification of complex behavioural and cognitive processes in real-time.
Addressing this need to further improve the accuracy and objective
identification of ADHD symptoms, a smartphone-based test, which incorporates
QbTest, was developed (*QbMT` - Quantified behavioral Mobile Test).
Study objective
The objective of the current study is to evaluate QbTest on a smartphone
(QbMT), in terms of:
1. The feasibility of QbMT as a smartphone software that incorporates the
Quantified behavioral Test (QbTest *)
2. The validity of QbMT in individuals diagnosed with ADHD
3. The association between QbMT and QbTest parameters
4. An exploration of additional eye-movement parameters that could be used as
indices of activity, attention, and impulsivity measures in QbMT for
individuals with ADHD.
Study design
Non-interventional cross-sectional clinical study
Study burden and risks
This study has a low risk of causing adverse events to the participants and
does not impact their clinical care and treatment. There are no significant
hazards in the proposed study. A minor risk is that participants may experience
some discomfort and boredom due to the length of the tests. The tests and tools
implemented as part of this study are non-invasive and safe for the test
taker. As the study involves the use of personal information, there is a
slight risk of loss of confidentiality. Data will be collected, stored, and
maintained according to the data protection regulations of the country in which
the site is located.
Cardellgatan 1
Stockholm 114 36
SE
Cardellgatan 1
Stockholm 114 36
SE
Listed location countries
Age
Inclusion criteria
•Provide written informed consent (including parent/legally authorized
representative (LAR) consent when this is required for individuals under 18
years old and assent as is required based on the age of participant) for QbMT;
•Aged > 6 years and < 60 years old;
•Referred for initial ADHD assessment;
•Have no prior diagnosis of ADHD;
•Have adequate sensory and physical ability to complete QbMT;
•Have not used psychostimulant medication for one month prior to test
completion.
Exclusion criteria
•intellectual disability designated by IQ<75);
•a concurrent medical diagnosis that could significantly affect test
performance (brain injuries, Parkinson*s disease, current epilepsy or active
seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias
(e.g., vascular dementia, Alzheimer disease, etc);
•other conditions that could affect test performance (migraine or other types
of severe headache, chronic or acute pain);
•substance use (e.g., alcohol, drugs) that may affect performance on the day of
the test.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81608.000.22 |