Study: NCT05340608

Intervention type: OTHER
Intervention: Smart, non-invasive shirt - Physiological parameters
Description: Observation Group One and Control Group - Participants in these groups will be asked to wear a smart, non-invasive shirt while watching two different five-minute videos. One video will show relaxing images and will emit relaxing music (relaxing video). The second video will present impressive human body deformities accompanied by anxious music (disturbing video). Both videos will be presented with the participant in a sitting position. The duration of the entire session will be approximately 15 minutes. For the whole duration of the session, the smart shirt will collect data on participants' physiological parameters (electrocardiogram, heart rate, heart rate variability, respiration rate, minute ventilation, and body movement). Collected data will be used to develop an ad-hoc algorithm to anticipate the challenging behavior of participants with autism spectrum disorder based on physiological data collected by the smart shirt.

Intervention type: OTHER
Intervention: Smart, non-invasive shirt - Physiological parameters
Description: Observation Group One and Control Group - Participants in these groups will be asked to wear a smart, non-invasive shirt while watching two different five-minute videos. One video will show relaxing images and will emit relaxing music (relaxing video). The second video will present impressive human body deformities accompanied by anxious music (disturbing video). Both videos will be presented with the participant in a sitting position. The duration of the entire session will be approximately 15 minutes. For the whole duration of the session, the smart shirt will collect data on participants' physiological parameters (electrocardiogram, heart rate, heart rate variability, respiration rate, minute ventilation, and body movement). Collected data will be used to develop an ad-hoc algorithm to anticipate the challenging behavior of participants with autism spectrum disorder based on physiological data collected by the smart shirt.

Intervention type: OTHER
Intervention: Smart, non-invasive shirt - Relation with challenging behaviors
Description: Observation Group Two - Each participant in this group will be asked to wear the smart, non-invasive shirt for seven consecutive days during waking hours, performing his usual daily activities. During the same seven days, the caregivers who care for the participant will be asked to accurately report the participant's status in a behavioral diary. Each evening, the data collected by the smart shirt will be uploaded to an online cloud along with the behavioral diary of the day. Collected data will be used to develop an ad-hoc algorithm able to anticipate the challenging behavior of participants with autism spectrum disorder based on physiological data collected by the smart shirt.

Intervention type: OTHER
Intervention: Smart, non-invasive shirt - Proof of Concept
Description: Proof of Concept - The participant with autism spectrum disorder enrolled in the proof-of-concept phase of this study will wear the smart, non-invasive shirt for seven days during all hours of attendance at the special school. At the end of the seven days, the healthcare professional and teacher who interacted with the developed system at the special school will participate in a focus group to analyze their experiences and opinions related to the system use.