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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Heart rate - Phase one (2)
研究概览
简要总结
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.
详细描述
Study goals
The current protocol consists of three phases, each with a specific goal. The first aim is to assess the differences in physiological reaction measured with a Smart Wearable Shirt (SWS) between adults with high-functioning Autism Spectrum Disorder (ASD) and typically developed peers. The second goal is to learn which physiological parameters can best predict the imminent onset of a Challenging Behavior (CB). The third aim is 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.
Study design
An observational study design will be implemented in the first two phases of the current research. In phase one, participants' physiological reactions to two visual stimuli will be collected and analyzed. In phase two, the physiological characteristics of CBs presented by people with ASD will be collected. A single case study with a mixed-method design will be implemented in phase three, where the system validity proof of concept will be performed.
Ethics and safety issues
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Heart rate - Phase one (2)
时间窗: Five-minute during the study Phase one.
Electrocardiogram (ECG) will be collected through a 1-lead electrocardiograph (256 Hz - 12 bits - Resolution LSB: 0.0064 mV). Heart rate (HR) will be calculated from the obtained ECG between two consecutive QRS complexes. Considering the time interval between two QRS complexes as "t", the corresponding temporal HR will be 60/t. ECG will be collected within the study Phase one while the participants watch a five-minute disturbing video.
Heart rate - Phase two
时间窗: Seven consecutive days during study Phase two.
Electrocardiogram (ECG) will be collected through a 1-lead electrocardiograph (256 Hz - 12 bits - Resolution LSB: 0.0064 mV). Heart rate (HR) will be calculated from the obtained ECG between two consecutive QRS complexes. Considering the time interval between two QRS complexes as "t", the corresponding temporal HR will be 60/t. ECG will be collected within the study Phase two during the participants' waking hours.
Heart rate - Phase one (1)
时间窗: Five-minute during the study Phase one.
Electrocardiogram (ECG) will be collected through a 1-lead electrocardiograph (256 Hz - 12 bits - Resolution LSB: 0.0064 mV). Heart rate (HR) will be calculated from the obtained ECG between two consecutive QRS complexes. Considering the time interval between two QRS complexes as "t", the corresponding temporal HR will be 60/t. ECG will be collected within the study Phase one while the participants watch a five-minute relaxing video.
Heart rate - Phase three
时间窗: Seven consecutive days during study Phase three.
Electrocardiogram (ECG) will be collected through a 1-lead electrocardiograph (256 Hz - 12 bits - Resolution LSB: 0.0064 mV). Heart rate (HR) will be calculated from the obtained ECG between two consecutive QRS complexes. Considering the time interval between two QRS complexes as "t", the corresponding temporal HR will be 60/t. ECG will be collected within the study Phase three during the participant's attendance at special school.
Behavioral Diary
时间窗: Seven consecutive days during study Phase two.
Participant's arousal level reported by participant's caregivers. Three arousal level will be reported: "Quiet", "Agitated", and "Challenging Behavior". The participants' behavioral diary will be collected within the study Phase two.
Quebec User Evaluation of Satisfaction with Assistive Technology second edition (QUEST 2.0)
时间窗: Phase three, at the end of the seven-day proof of concept trial - one administration.
It is a 12-item questionnaire designed to assess users' satisfaction with a wide range of assistive technology. It will be administered to healthcare professionals and teachers who interacted with the system at the participant's special school.
Focus Group
时间窗: Phase three, at the end of the seven-day proof of concept trial - one three-hour session.
It is a technique to produce a controlled discussion on specific issues within a group of people that share different relations with the focused topics. It will be conducted with the researcher and the healthcare professionals and teachers who interacted with the system at the participant's special school to answer the following research questions: a) Did wearing the SWS upset the participants? b) Was the system able to detect all relevant CB? c) Did having been informed of the occurrence of CB allow the in-time application of appropriate prevention strategies? d) Has the use of the system reduced the amount of CB? e) What improvements can be applied to the system to increase its effectiveness?
次要结局
未报告次要终点