Status:
COMPLETED
Development and Validation of a System for the Anticipation of Challenging Behaviors
Lead Sponsor:
Ariel University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
20-40 years
Brief 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 s...
Detailed Description
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) b...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Observation Group One:
- diagnosis of High Functioning Autism Spectrum Disorder;
- age between 20 and 40 years.
- Exclusion Criteria for Observation Group One:
- the presence of heart disease;
- comorbidity with other neurodevelopmental disorders.
- Inclusion Criteria for Observation Group Two:
- diagnosis of Autism Spectrum Disorder;
- frequent emission of aggressive and disruptive challenging behaviors (at least three times per week);
- age between 20 and 40 years.
- Exclusion Criteria for Observation Group Two:
- the presence of heart disease;
- comorbidity with other neurodevelopmental disorders.
- Inclusion Criteria for Proof of Concept:
- diagnosis of Autism Spectrum Disorder;
- frequent emission of aggressive and disruptive challenging behaviors (at least three times per week);
- attending a special school for at least eight hours a day;
- age between 20 and 40 years.
- Exclusion Criteria for Proof of Concept:
- the presence of heart disease;
- comorbidity with other neurodevelopmental disorders.
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05340608
Start Date
June 1 2022
End Date
September 30 2022
Last Update
December 30 2022
Active Locations (1)
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1
Ariel University
Ariel, Israel, 4070000