Attention Deficit Hyperactivity DisorderADHD360NCT04362982
Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
A study testing ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring. in people with Attention Deficit Hyperactivity Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (1) Participants should be between 7 and 16 years old
- (2) Diagnosed ADHD by an approved body of Ministry of Health
- (3) Participants willing to follow the study protocol and procedures
- (4) Participants with ADHD symptoms that they are not induced by an organic disease
- (5) Participants' parents voluntarily provided written consent for their children's participation in the study.
Who cannot join
- (1) Participants in ADHD group having other disorders apart from ADHD
- (2) Parents who refuse to give written consent for their children's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention.
Read the detailed description
The ADHD360 project develop an integrated platform having as core elements a serious game along with a mobile application for monitoring of ADHD behaviors in a SMART (Specific, Measurable, Attainable, Realistic and Timely) way. The design of the serious game is based on both Diagnostic and Statistical Manual of Mental Disorders (version V(American Psychiatric Association, 2013)) along with neuropsychological tools, easily transferred to game, on a specific ADHD behavior. The primary objective of the project is to explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users. The secondary objective is to use the platform as an intervention. To this scope, a two-phase pilot study will be performed recruiting at least twenty (20) participants (10 ADHD; 10 non-ADHD) with ages ranging from 7 to 16 years. In the first stage, participants will undergo a neuropsychological evaluation as well as interact with the serious game two times (30-45 minutes/each time). After all participants have completed the first part of the pilot tests, a preliminary analysis of the data will be carried out using modern Machine Learning Methods in order to explore the discriminating capacity of the game. In the second stage, participants will interact with the platform for ten (10) weeks in total (2-3 times/30-45 minutes each). At the end of the second stage, the participants will undergo a neuropsychological evaluation following the procedures of the first one. The partners involved in the implementation of the project are the Intelligent Systems Lab (School of Computer Science, AUTH), the MEDPHYS Laboratory (School of Medicine, AUTH) and the Second Method (TSM) company. The partners cover the expertise required in data analysis, machine learning, medical record keeping, software development and game design (gamification). ADHD360 is co-financed by the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH - CREATE - INNOVATE [Τ1ΕΔΚ-01680].
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.
- Keywords
- Attention Deficit Hyperactivity Disorder, Serious games, Machine Learning, DSM-V, WHAAM
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.Other
Clinical trials will include two parts. The first part includes three visits. In the first visit, children and their parents will come to the Laboratory of Medical Physics to be informed regarding the experimental procedures, sign the consent form and familiarize with the scientific staff involved in the project as well as the lab enviroment. In the second visit, children will undergo an neuropsychological assessment delivered by an experienced pscychologist. Afterwards, they will interact with the ADHD360 platfrom for 30-45 minutes. In the third visit, participants will interact with the ADHD360 platfrom for 30-45 minutes. In the second part, participants will use the ADHD360 platfrom two or three times per week for about 30-45 minutes. At the end of the second part, participants will undergo a neuropsychological evalutation following the same procedures as the first one.
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Experimental | In the first part of the clinical trials, ADHD cohorts are going to undergo a neuropsychological assessement. Moreover, they will interact with the serious game twice (30-45 minutes/each time). In the second part, participants will interact with game two or three times per week (30-45 minutes/each time). Finally, a neuropsychological assessment will be administered following the procedures of the first one. Receives: Other: ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring. |
| non-ADHD | Active comparator | Non-ADHD group will follow the same procedures as the experimental one. Receives: Other: ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore whether the game analytics could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded gameplay scores for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Measured: 8 months
Explore whether the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded data of attention for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Measured: 8 months
Explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded gameplay time for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Measured: 8 months
Investigate the impact of ADHD360 platfrom as intervention on general intelligence index
Change in WISC-III
Measured: 12 months
Secondary outcomes (2)
Change in attention
Changes in scores of Test of Everyday Attention for Children subtests will be evaluated before and after the intervention.
Measured: 10 weeks
Change in the frequency of ADHD symptoms
Changes in scores of ADHD-RATING SCALE-IV will be evaluated before and after the intervention.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
- Investigators
- Ioannis Vlahavas, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362982
- Sponsor's protocol ID
- 5162.18.12.2019
- Acronym
- ADHD360
- Status last verified
- May 2023
- First submitted
- 10 Apr 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandria N, Petronikolou V, Lazaridis A, Karapiperis C, Kouloumpris E, Spachos D, Fachantidis A, Vasiliou D, Vlahavas I, Bamidis P. Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder: Protocol for a Nonrandomized Controlled Pilot Study. JMIR Res Protoc. 2022 Sep 28;11(9):e40189. doi: 10.2196/40189.
PubMed 36169998
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
- ClinicalTrials.gov ID
- NCT04362982
- Acronym / sponsor ID
- ADHD360 / 5162.18.12.2019
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Serious games, Machine Learning, DSM-V, WHAAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention.
Detailed description
The ADHD360 project develop an integrated platform having as core elements a serious game along with a mobile application for monitoring of ADHD behaviors in a SMART (Specific, Measurable, Attainable, Realistic and Timely) way. The design of the serious game is based on both Diagnostic and Statistical Manual of Mental Disorders (version V(American Psychiatric Association, 2013)) along with neuropsychological tools, easily transferred to game, on a specific ADHD behavior. The primary objective of the project is to explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users. The secondary objective is to use the platform as an intervention. To this scope, a two-phase pilot study will be performed recruiting at least twenty (20) participants (10 ADHD; 10 non-ADHD) with ages ranging from 7 to 16 years. In the first stage, participants will undergo a neuropsychological evaluation as well as interact with the serious game two times (30-45 minutes/each time). After all participants have completed the first part of the pilot tests, a preliminary analysis of the data will be carried out using modern Machine Learning Methods in order to explore the discriminating capacity of the game. In the second stage, participants will interact with the platform for ten (10) weeks in total (2-3 times/30-45 minutes each). At the end of the second stage, the participants will undergo a neuropsychological evaluation following the procedures of the first one. The partners involved in the implementation of the project are the Intelligent Systems Lab (School of Computer Science, AUTH), the MEDPHYS Laboratory (School of Medicine, AUTH) and the Second Method (TSM) company. The partners cover the expertise required in data analysis, machine learning, medical record keeping, software development and game design (gamification). ADHD360 is co-financed by the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH - CREATE - INNOVATE [Τ1ΕΔΚ-01680].
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| ADHD | Experimental | Other: ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.In the first part of the clinical trials, ADHD cohorts are going to undergo a neuropsychological assessement. Moreover, they will interact with the serious game twice (30-45 minutes/each time). In the second part, participants will interact with game two or three times per week (30-45 minutes/each time). Finally, a neuropsychological assessment will be administered following the procedures of the first one. |
| non-ADHD | Active comparator | Other: ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.Non-ADHD group will follow the same procedures as the experimental one. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- (1) Participants should be between 7 and 16 years old
- (2) Diagnosed ADHD by an approved body of Ministry of Health
- (3) Participants willing to follow the study protocol and procedures
- (4) Participants with ADHD symptoms that they are not induced by an organic disease
- (5) Participants' parents voluntarily provided written consent for their children's participation in the study.
Key exclusion criteria (2 listed)
- (1) Participants in ADHD group having other disorders apart from ADHD
- (2) Parents who refuse to give written consent for their children's participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.Clinical trials will include two parts. The first part includes three visits. In the first visit, children and their parents will come to the Laboratory of Medical Physics to be informed regarding the experimental procedures, sign the consent form and familiarize with the scientific staff involved in the project as well as the lab enviroment. In the second visit, children will undergo an neuropsychological assessment delivered by an experienced pscychologist. Afterwards, they will interact with the ADHD360 platfrom for 30-45 minutes. In the third visit, participants will interact with the ADHD360 platfrom for 30-45 minutes. In the second part, participants will use the ADHD360 platfrom two or three times per week for about 30-45 minutes. At the end of the second part, participants will undergo a neuropsychological evalutation following the same procedures as the first one. | Other | ADHD, non-ADHD |
Primary outcome
Explore whether the game analytics could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Time frame: 8 months
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded gameplay scores for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Explore whether the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Time frame: 8 months
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded data of attention for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Time frame: 8 months
After all participants completed the first part of the clinical trials, an analysis of the data collected from the platform will be carried out. This includes processing recorded gameplay time for the extraction of useful features that, in turn, shall be used for training and evaluating modern Machine Learning methods, such as Neural Networks, Support Vector Machines (SVMs), Random Forests, Decision Trees, and/or k-Nearest Neighbors (kNN), in order to learn the differentiating properties of ADHD cases against non-ADHD cases within the game.
Investigate the impact of ADHD360 platfrom as intervention on general intelligence index
Time frame: 12 months
Change in WISC-III
2 secondary outcomes
Change in attention
Time frame: 10 weeks
Change in the frequency of ADHD symptoms
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 36169998Pandria N, Petronikolou V, Lazaridis A, Karapiperis C, Kouloumpris E, Spachos D, Fachantidis A, Vasiliou D, Vlahavas I, Bamidis P. Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder: Protocol for a Nonrandomized Controlled Pilot Study. JMIR Res Protoc. 2022 Sep 28;11(9):e40189. doi: 10.2196/40189.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Vlahavas principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring. in people with Attention Deficit Hyperactivity Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore whether the game analytics could discriminate the ADHD from non-ADHD users of the ADHD360 platform. (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.