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

NCT04362982 | Completed

• 1 other identifier: 5162.18.12.2019
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Serious games; Machine Learning; DSM-V; WHAAM

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  8 months

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

  Change in WISC-III

  12 months

Secondary Outcomes (2)

• Change in attention

  10 weeks

• Change in the frequency of ADHD symptoms

  10 weeks

Study Arms (2)

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.

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.

Other: ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.

Interventions

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.

ADHD; non-ADHD

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

Location

Related Publications (1)

• 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.

  PMID: 36169998 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ioannis Vlahavas

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 27, 2020
• Study Start: April 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)