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Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360) (ADHD360)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Serious games, Machine Learning, DSM-V, WHAAM

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.

Sites / Locations

  • Laboratory of Medical Physics, AUTH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADHD

non-ADHD

Arm Description

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 group will follow the same procedures as the experimental one.

Outcomes

Primary Outcome Measures

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.
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.
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.
Investigate the impact of ADHD360 platfrom as intervention on general intelligence index
Change in WISC-III

Secondary Outcome Measures

Change in attention
Changes in scores of Test of Everyday Attention for Children subtests will be evaluated before and after the intervention.
Change in the frequency of ADHD symptoms
Changes in scores of ADHD-RATING SCALE-IV will be evaluated before and after the intervention.

Full Information

First Posted
April 10, 2020
Last Updated
May 3, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT04362982
Brief Title
Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
Acronym
ADHD360
Official Title
Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Serious games, Machine Learning, DSM-V, WHAAM

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADHD
Arm Type
Experimental
Arm Description
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.
Arm Title
non-ADHD
Arm Type
Active Comparator
Arm Description
Non-ADHD group will follow the same procedures as the experimental one.
Intervention Type
Other
Intervention Name(s)
ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Explore whether the game analytics could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Description
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.
Time Frame
8 months
Title
Explore whether the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Description
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.
Time Frame
8 months
Title
Explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
Description
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.
Time Frame
8 months
Title
Investigate the impact of ADHD360 platfrom as intervention on general intelligence index
Description
Change in WISC-III
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in attention
Description
Changes in scores of Test of Everyday Attention for Children subtests will be evaluated before and after the intervention.
Time Frame
10 weeks
Title
Change in the frequency of ADHD symptoms
Description
Changes in scores of ADHD-RATING SCALE-IV will be evaluated before and after the intervention.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Vlahavas
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Medical Physics, AUTH
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36169998
Citation
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.
Results Reference
derived
Links:
URL
https://www.adhd360.eu/
Description
Related Info

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Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)

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