Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice

Study Overview
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Brief Summary
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The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

Detailed Description
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The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice. The aim is to analyse in an automated and standardised way video recording during a blood test performed as part of routine follow-up care for people presenting ASD (children and adults), qualitative data (type of emotion) and quantitative (intensity) Emotional facial reactions Behavioural reactions (video recording of participants' movements) Physiological reactions (wireless smart watch worn on the wrist) Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)

Official Title
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Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Video & movements recording
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants : Person over 6 years of age Person who consent to participate in the study Membership of the social security scheme Person who not received analgesic treatment that may interfere with pain perception Person with medical prescription for blood sample Participants with ASD : Person with ASD diagnosis If applicable, legal authority consent to participate in the study Exclusion Criteria: All participants : Person with unstabilized drug therapy Person with acute or chronic pain Person with pathology or receiving a treatment which can have an impact in modification of the pain Person with oculomotor and/or neuro-motor disorders Pregnant or breastfeeding woman Person with deprivation of liberty Person who no consent to participate in the study or no consent to realised video recording Participants without ASD : Protected adult Person with ASD diagnosis

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Epidemiology
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Epidemiology<br>Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test Passing self and hetero questionnaires of temotion felt and perceived. | Behavioral: Video & movements recording<br>* Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test<br>Behavioral: Questionnaires<br>* Passing self and hetero questionnaires of emotion felt and perceived.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial expression during blood sample | Evaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware. | through study completion, an average of 1 to 6 months | 
| Body movement during blood sample | Evaluation of body movement during blood sample in people with ASD as compared to healthy people with EMPATICA watch and Face, Legs, Activity, Cry, Consolabilty (FLACC) scale | through study completion, an average of 1 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of emotion felt by participants during blood sample | Evaluation of emotion felt by participants (anxiety, stress, pain, apprehension…) during blood sample with implified Scale for Assessing Pain in Dyscommunicatives People with Autism Spectrum Disorders (ESSDA) and Pain Assessment Grid - Intellectual Disability (GEDDI) scales | through study completion, an average of 1 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions