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NCT Number: NCT04638452

Evaluation of Behavioural Psycho & Physiological Responses in People With 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.

Recruiting

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

Location status: Recruiting

Location contact

Anouck AMESTOY, MD

CONTACT

[email protected]

05 56 56 67 19

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video & movements recording

Behavioral

Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test

Questionnaires

Behavioral

Passing self and hetero questionnaires of emotion felt and perceived.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Anouck AMESTOY, MD

CONTACT

[email protected]

0556566719

helen SAVARIEAU

CONTACT

[email protected]

0556563556

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Other Gov

Registry information

Official study title

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

Acronym: AUTICOPP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2020
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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