Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice
AUTICOPP
Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
February 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
March 16, 2026
March 1, 2026
5.8 years
October 15, 2020
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Evaluation of emotion felt by participants during blood sample
through study completion, an average of 1 to 6 months
Study Arms (1)
Epidemiology
OTHERVideo 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.
Interventions
Passing self and hetero questionnaires of emotion felt and perceived.
Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Charles PERRENS
Bordeaux, 33076, France
Related Publications (6)
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/s10803-010-0944-8.
PMID: 20108030RESULTHirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bolte 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.
PMID: 26541693RESULTBreau 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. doi: 10.1001/archpedi.157.12.1219.
PMID: 14662579RESULTBreau 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. doi: 10.1017/s001216220400060x.
PMID: 15174527RESULTDubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. doi: 10.1155/2010/749275. French.
PMID: 20808970RESULTAllely 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.
PMID: 23843740RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anouck AMESTOY, MD
Physician
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
November 20, 2020
Study Start
February 8, 2021
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share