Clinical trial NCT04362982: Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
Official title: Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Serious games
Machine Learning
DSM-V
WHAAM
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 43
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: SUPPORTIVE_CARE

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 \[Τ1ΕΔΚ-01680\].

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.

Primary outcomes:
measure: Explore whether the game analytics could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
timeFrame: 8 months
measure: Explore whether the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
timeFrame: 8 months
measure: Explore whether the game analytics along with the monitoring data could discriminate the ADHD from non-ADHD users of the ADHD360 platform.
timeFrame: 8 months
measure: Investigate the impact of ADHD360 platfrom as intervention on general intelligence index
timeFrame: 12 months
Secondary outcomes:
measure: Change in attention
timeFrame: 10 weeks
measure: Change in the frequency of ADHD symptoms
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics, AUTH
Study officials:
affiliation: Professor
name: Ioannis Vlahavas
role: PRINCIPAL_INVESTIGATOR
References:
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.