Autism Spectrum DisorderAUTICOPPNCT04638452
Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice
A study testing Video & movements recording and Questionnaires in people with Autism Spectrum Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Video & movements recording and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- Participants with ASD :
- Person with ASD diagnosis
- If applicable, legal authority consent to participate in the study
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Charles PERRENS
Bordeaux, 33076
Anouck AMESTOY, MD, 05 56 56 67 19, aamestoy@ch-perrens.fr
About this study
Official title: Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
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.
Read the 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)
- Conditions
- Autism Spectrum Disorder
- Being tested
- Video & movements recording, Questionnaires
- Keywords
- autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions
- Medical subject headings
- Autism Spectrum Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video & movements recordingBehavioural
Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test
QuestionnairesBehavioural
Passing self and hetero questionnaires of emotion felt and perceived.
| Study group | Role | What they receive |
|---|---|---|
| Epidemiology | Other | 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. Receives: Behavioral: Video & movements recording; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: through study completion, an average of 1 to 6 months
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Feb 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Epidemiology
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anouck AMESTOY, MD, Study director, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638452
- Sponsor's protocol ID
- 2020-A00693-36
- Acronym
- AUTICOPP
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20108030Hirvikoski 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.
PubMed 26541693Breau 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.
PubMed 14662579Breau 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.
PubMed 15174527Dubois 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.
PubMed 20808970Allely 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.
PubMed 23843740
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
- ClinicalTrials.gov ID
- NCT04638452
- Acronym / sponsor ID
- AUTICOPP / 2020-A00693-36
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Epidemiology
| Arm | Type | Receives |
|---|---|---|
| Epidemiology | Other | Behavioral: Video & movements recording, Behavioral: QuestionnairesVideo 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. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video & movements recordingVideo recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test | Behavioural | Epidemiology |
| QuestionnairesPassing self and hetero questionnaires of emotion felt and perceived. | Behavioural | Epidemiology |
Primary outcome
Facial expression during blood sample
Time frame: through study completion, an average of 1 to 6 months
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
Time frame: through study completion, an average of 1 to 6 months
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
1 secondary outcome
Evaluation of emotion felt by participants during blood sample
Time frame: through study completion, an average of 1 to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 20108030Hilton 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 publication: PubMed 26541693Hirvikoski 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 publication: PubMed 14662579Breau 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 publication: PubMed 15174527Breau 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 publication: PubMed 20808970Dubois 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 publication: PubMed 23843740Allely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anouck AMESTOY, MD study director
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video & movements recording and Questionnaires in people with Autism Spectrum Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouck AMESTOY, MD (0556566719, aamestoy@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial expression during blood sample (time frame: through study completion, an average of 1 to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638452, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.