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

Autism Spectrum Disorder Clinical Trial

— AUTICOPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638452
• Other study ID #: 2020-A00693-36
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: Anouck AMESTOY, MD
• Phone: 0556566719
• Email: aamestoy[@]ch-perrens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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
• Questionnaires
Passing self and hetero questionnaires of emotion felt and perceived.

Locations

Country	Name	City	State
France	Centre Hospitalier Charles PERRENS	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (6)

Allely CS. Pain sensitivity and observer perception of pain in individuals with autistic spectrum disorder. ScientificWorldJournal. 2013 Jun 13;2013:916178. doi: 10.1155/2013/916178. Print 2013. Review. — View Citation

Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. — View Citation

Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. — View Citation

Dubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. Review. French. — View Citation

Hilton CL, Harper JD, Kueker RH, Lang AR, Abbacchi AM, Todorov A, LaVesser PD. Sensory responsiveness as a predictor of social severity in children with high functioning autism spectrum disorders. J Autism Dev Disord. 2010 Aug;40(8):937-45. doi: 10.1007/s — View Citation

Hirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bölte S. Premature mortality in autism spectrum disorder. Br J Psychiatry. 2016 Mar;208(3):232-8. doi: 10.1192/bjp.bp.114.160192. Epub 2015 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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