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Completed

NCT Number: NCT04362982

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Investigate the impact of ADHD360 platfrom as intervention on general intelligence index

    Time frame: 12 months

    Change in WISC-III

Secondary outcomes

  1. Change in attention

    Time frame: 10 weeks

    Changes in scores of Test of Everyday Attention for Children subtests will be evaluated before and after the intervention.

  2. Change in the frequency of ADHD symptoms

    Time frame: 10 weeks

    Changes in scores of ADHD-RATING SCALE-IV will be evaluated before and after the intervention.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Acronym: ADHD360

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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