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

March 13, 2026 updated by: Centre Hospitalier Charles Perrens, Bordeaux

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Centre Hospitalier Charles Perrens
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 to 6 months
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
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
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
through study completion, an average of 1 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Investigators

  • Study Director: Anouck AMESTOY, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00693-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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