Clinical trial NCT04638452: Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice
Official title: Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism spectrum disorders
behaviour
emotions
Physiological reactions
Psychological reactions
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2020-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Epidemiology
Primary purpose: OTHER

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Facial expression during blood sample
timeFrame: through study completion, an average of 1 to 6 months
measure: Body movement during blood sample
timeFrame: through study completion, an average of 1 to 6 months
Secondary outcomes:
measure: Evaluation of emotion felt by participants during blood sample
timeFrame: through study completion, an average of 1 to 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles PERRENS
Study officials:
affiliation: Physician
name: Anouck AMESTOY, MD
role: STUDY_DIRECTOR
References:
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/s10803-010-0944-8.
citation: Hirvikoski 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.
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. doi: 10.1001/archpedi.157.12.1219.
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. doi: 10.1017/s001216220400060x.
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. doi: 10.1155/2010/749275. French.
citation: 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.