At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Development and Validation of a System for the Anticipation of Challenging Behaviors of People With Autism Spectrum Disorder Based on a Smart Shirt: a Mixed-method Design
In Brief
An observational study evaluating Smart, non-invasive shirt - Physiological parameters, Smart, non-invasive shirt - Relation with challenging behaviors, and 1 other intervention for Autism Spectrum Disorder. Completed, enrolled 51 participants across 1 site.
Detailed Summary
Most people with autism spectrum disorder (ASD) present at least one form of challenging behavior (CB). Self-injurious, aggressive, and disruptive CBs linked with social interaction, community-based service exclusion, and a life quality reduction for people with ASD, their caregivers, and health professionals. The current study has three objectives: 1) to assess the differences in the physiological reaction of high-functioning adults with ASD and typically developed peers, using bio-signal measurements such as heart rate derived from wearable Smart Shirt (SS), 2) to learn which physiological parameters can best predict the imminent onset of a CB, and 3) to develop a system able to predict the incoming occurrence of a CB in real-time and inform the caregiver through an alert notification sent on a smartphone application. Methods and analysis: comparison between physiological parameters will carry out with two groups of 20 participants with and without ASD. Each participant will be asked to watch two five-minute videos while wearing the SS: one showing relaxing images and the other impressive human body deformities. To identify the matching between the physiological parameters variation collected by the SS and the CBs, ten participants with ASD and aggressive or disruptive CBs will be recruited. Each of these participants will wear the SS for seven consecutive days during waking hours, performing their usual daily activities. During the same seven days, the caregivers who care for the participant will fill a behavioral diary with the participant's status, reporting the times of the day in which he is quiet, agitated and the occurrence of CBs. A learning algorithm capable of predicting immediate CBs occurrence based on physiological parameter variations will be developed together with an ad hoc smartphone application. If the algorithm detects the possibility of an incoming CB, a notification will be sent to the caregiver's smartphone to inform of the possible advent of a CB, therefore enabling the implementation of the selected intervention strategy. After developing the algorithm and related smartphone application, a system efficiency proof of concept (POC) will be carried out with one participant with ASD and CB for seven days in a special school setting with healthcare professionals and teachers. A focus group including health professionals will be conducted after the POC to identify the strengths and weaknesses of the developed system.
Study Details
Timeline
Interventions
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.
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.
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.