Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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].
    

Intervention name(s): ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Attention Deficit Hyperactivity Disorder; Serious games; Machine Learning; DSM-V; WHAAM