Development and Validation of a System for the Anticipation of Challenging Behaviors
NCT05340608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51
Last updated 2022-12-30
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.
Conditions
Interventions
- OTHER
-
Smart, non-invasive shirt - Physiological parameters
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.
- OTHER
-
Smart, non-invasive shirt - Relation with challenging behaviors
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.
- OTHER
-
Smart, non-invasive shirt - Proof of Concept
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.
Sponsors & Collaborators
-
Ariel University
lead OTHER
Principal Investigators
-
Meir Lotan, PhD · Department of Physiotherapy, School of Health Sciences, Ariel University
-
Moti Zwilling, PhD · Department of Economics and Business Administration, Ariel University
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2022-09-30
- Completion
- 2022-09-30
Countries
- Israel
Study Locations
More Related Trials
-
Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
NCT00404846 ·Status: UNKNOWN ·Phase: NA
-
The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders
NCT03323931 ·Status: COMPLETED ·Phase: NA
-
Examining an Adaptive Telehealth Intervention
NCT03840642 ·Status: COMPLETED ·Phase: NA
-
Effects of Parent-Mediated Intervention on Restricted and Repetitive Behaviors in Children With ASD
NCT05960981 ·Status: COMPLETED ·Phase: NA
-
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
NCT04992169 ·Status: COMPLETED ·Phase: NA
-
A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
NCT03486860 ·Status: COMPLETED ·Phase: NA
-
A Pilot Trial Examining Digital Parent Training Programs
NCT05344885 ·Status: COMPLETED ·Phase: NA
-
Using the Prevent-Teach-Reinforce Model to Reduce Problem Behaviors in Children With Autism Spectrum Disorders
NCT02153203 ·Status: COMPLETED ·Phase: NA
-
Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms
NCT06311370 ·Status: COMPLETED
-
Optimizing Outcomes for Young Autistic Children
NCT05926687 ·Status: RECRUITING ·Phase: PHASE2
-
Equine-Assisted Therapy in the Behavior of Individuals With Autism
NCT07131436 ·Status: COMPLETED ·Phase: NA
-
Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder
NCT06438120 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Developing Mental Health Supports for Autistic Students
NCT04926090 ·Status: COMPLETED ·Phase: NA
-
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
NCT05268796 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation
NCT05371912 ·Status: COMPLETED ·Phase: NA
-
Harnessing Communication Preferences
NCT07278544 ·Status: RECRUITING ·Phase: NA
-
Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism
NCT03152383 ·Status: COMPLETED ·Phase: NA
-
Group Based Parent Training for Children With Autism and Disruptive Behaviors
NCT04097457 ·Status: UNKNOWN ·Phase: NA
-
Engaging Siblings of Adults With Autism in Future Planning
NCT03374072 ·Status: COMPLETED ·Phase: NA
-
The Effects of Exercise in Anxiety in Children With ASD
NCT03860389 ·Status: UNKNOWN ·Phase: NA
-
Investigation of Brain Plasticity in Autism Spectrum Disorders
NCT04706364 ·Status: UNKNOWN
-
Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients
NCT06712784 ·Status: RECRUITING ·Phase: NA
-
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
NCT04369417 ·Status: COMPLETED ·Phase: NA
-
Robot-Mediated Intervention for Children With Autism Spectrum Disorders
NCT02617342 ·Status: COMPLETED ·Phase: NA
-
Effects of Multiple-Session Transcranial Direct Current Stimulation (tDCS) on Behavioral, Physiological, and Electrophysiological Measures With Adults With Autism Spectrum Disorder (ASD)
NCT06495684 ·Status: RECRUITING ·Phase: NA