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

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ClinicalTrials.gov Identifier: NCT04638452
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Charles Perrens, Bordeaux

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Video & movements recording Behavioral: Questionnaires Not Applicable

Detailed Description:

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)

  1. Emotional facial reactions
  2. Behavioural reactions (video recording of participants' movements)
  3. Physiological reactions (wireless smart watch worn on the wrist)
  4. Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Epidemiology
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Epidemiology
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
Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test

Behavioral: Questionnaires
Passing self and hetero questionnaires of emotion felt and perceived.


Outcome Measures
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Primary Outcome Measures :
  1. Facial expression during blood sample [ Time Frame: through study completion, an average of 1 to 6 months ]
    Evaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware.

  2. Body movement during blood sample [ Time Frame: through study completion, an average of 1 to 6 months ]
    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


Secondary Outcome Measures :
  1. Evaluation of emotion felt by participants during blood sample [ Time Frame: through study completion, an average of 1 to 6 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638452


Contacts
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Contact: Anouck AMESTOY, MD 0556566719 aamestoy@ch-perrens.fr
Contact: helen SAVARIEAU 0556563556 hsavarieau@ch-perrens.fr

Locations
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France
Centre Hospitalier Charles PERRENS Recruiting
Bordeaux, France, 33076
Contact: Anouck AMESTOY, MD    05 56 56 67 19    aamestoy@ch-perrens.fr   
Sponsors and Collaborators
Centre Hospitalier Charles Perrens, Bordeaux
Investigators
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Study Director: Anouck AMESTOY, MD Physician
More Information
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Publications of Results:

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Responsible Party: Centre Hospitalier Charles Perrens, Bordeaux
ClinicalTrials.gov Identifier: NCT04638452    
Other Study ID Numbers: 2020-A00693-36
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Charles Perrens, Bordeaux:
autism spectrum disorders
behaviour
emotions
Physiological reactions
Psychological reactions
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders