Back to results

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

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Video & movements recording

Questionnaires

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Centre Hospitalier Charles PERRENSRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Epidemiology

Arm 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.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04638452

First Posted

October 15, 2020

Last Updated

August 17, 2021

Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT04638452

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Epidemiology

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Epidemiology

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Video & movements recording

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Questionnaires

Intervention Description

Passing self and hetero questionnaires of emotion felt and perceived.

Primary Outcome Measure Information:

Title

Facial expression during blood sample

Description

Evaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware.

Time Frame

through study completion, an average of 1 to 6 months

Title

Body movement during blood sample

Description

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

Time Frame

through study completion, an average of 1 to 6 months

Secondary Outcome Measure Information:

Title

Evaluation of emotion felt by participants during blood sample

Description

Time Frame

through study completion, an average of 1 to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anouck AMESTOY, MD

Phone

0556566719

aamestoy@ch-perrens.fr

First Name & Middle Initial & Last Name or Official Title & Degree

helen SAVARIEAU

Phone

0556563556

hsavarieau@ch-perrens.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anouck AMESTOY, MD

Organizational Affiliation

Physician

Official's Role

Study Director

Facility Information:

Facility Name

Centre Hospitalier Charles PERRENS

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anouck AMESTOY, MD

Phone

05 56 56 67 19

aamestoy@ch-perrens.fr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20108030

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.

Results Reference

result

PubMed Identifier

26541693

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.

Results Reference

result

PubMed Identifier

14662579

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.

Results Reference

result

PubMed Identifier

15174527

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.

Results Reference

result

PubMed Identifier

20808970

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.

Results Reference

result

PubMed Identifier

23843740

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs