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

Centre Hospitalier Charles Perrens, Bordeaux

Status: Unknown

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Questionnaires; Behavioral: Video & movements recording

Study type: Interventional

Funder types: Other

Identifiers

NCT04638452

2020-A00693-36

Details and patient eligibility

About

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.

Full 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)

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Epidemiology

Other group

Description:

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.

Treatment:

Behavioral: Questionnaires

Behavioral: Video & movements recording