AutismYODANCT05577234
Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients (YODA)
A study testing Animal-assisted intervention and Venham scale modified by Veerkamp in people with Autism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- Animal-assisted intervention and Venham scale modified by Veerkamp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2023to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minors aged ≥ 6 to ≤ 17 years,
- Carriers of Autism Spectrum Disorder.
- Child with an average Venham scale score ≥ 3 at the end of the care of the inclusion session
- Who accept the presence of the dog
- Who declare having been in contact with a dog in the past
- Consent from the child's legal guardians for the child's participation in the study,
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- Be affiliated to a social security scheme in their own name or be the legal guardian of a person with parental authority.
- A state of health requiring a simple, non-complex dental procedure (preventive, carious, traumatic or orthodontic care, excluding complex surgery in the operating theatre)
- A state of health requiring a dental treatment protocol consisting of at least 3 scheduled treatment sessions spaced at least 7 days and no more than 21 days apart.
Who cannot join
- Child with dog allergy
- Cynophobia
- Who claims never to have been exposed to a dog (allergy risk not assessed)
- Patient on AME
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients
The purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism.
Read the detailed description
The particularity of some disabled patients, especially those with an autism spectrum disorder, is represented by anxiety, which can range from a slight tension to screaming or even extreme agitation. This behavior can make therapeutic management difficult, both for the patient and the caregiver. This is particularly true for oral health care, where the cooperation of the patient is essential. Conventional behavioral approaches, with implementation of a multitude of adaptive strategies, has a fundamental role to play. With disabled patients, these techniques are most often based on non-verbal or para-verbal communication rather than on linguistic procedures. In this context, an Animal Assisted Intervention could be of major help. The primary outcome is average child anxiety during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third session of care (without animal-assisted therapy).
- Conditions
- Autism
- Being tested
- Animal-assisted intervention, Venham scale modified by Veerkamp
- Keywords
- Animal-assisted therapy, child, autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted interventionOther
The dog accompanied by the zootherapist will participate in the care of sessions 1 and 2. During these two sessions, the dog will be present with the child in the waiting room until the end of the dental consultation. Session 3 will take place without the dog being present.The usual management with conventional behavioural strategies and possible administration of MEOPA will be implemented during the 3 treatment sessions.
Venham scale modified by VeerkampBehavioural
The Venham scale modified by Veerkamp, based on observation of one's behaviour and used in current practice, ranges from 0 (relaxed) to 5 (totally disconnected from the reality of danger).
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted intervention | Experimental | The dog accompanied by the zootherapist will participate in the care of the sessions. During these sessions, the dog will be brought into the child's presence in the waiting room until the end of the dental consultation. Receives: Other: Animal-assisted intervention; Behavioral: Venham scale modified by Veerkamp |
| Standard care | Other | The treatment sessions will only involve the use of conventional behavioural strategies. Receives: Behavioral: Venham scale modified by Veerkamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average anxiety
Average anxiety of the child during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third treatment session (without animal assisted intervention). Score on a scale : Min = 0 Max = 5 : 0 = relaxed, 1 = uneasy, 2 = tense, 3 = unwilling, 4 = very troubled, 5 = totally out of touch
Measured: through study completion, an average of 3 months
Secondary outcomes (4)
Evaluate the success of the care session (complete achievement of the planned objective)
Overall success of the session: dental care completed in its entirety
Measured: at the end of each follow-up visit, on average 3 months
Validate the use of MEOPA administration
Use of MEOPA: administration of MEOPA during the session
Measured: at the end of each follow-up visit, on average 3 months
Assess the types of acts for which animal assisted intervention reduces the child's anxiety
Types of procedures for which animal assisted intervention reduces anxiety: assessment of anxiety by the Venham scale modified by Verkamp measured at the end of each type of procedure : waiting room, entry into practice, X-rays, anaesthesia, placement of the dam, use of rotary instruments
Measured: at the end of each follow-up visit, on average 3 months
Assessing the safety of animal assisted intervention for oral care
Occurrence of undesirable events associated with the animal assisted intervention, including infectious events of the zoonosis type (assessment by the practitioner at the beginning of each session and by the accompanying person who must report to the practitioner any manifestation that has appeared since the last session), episodes of agitation linked to the presence of the dog, bites.
Measured: at the end of each follow-up visit, on average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start24 Mar 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Marc TRELUYER, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577234
- Sponsor's protocol ID
- APHP220662
- Other IDs
- 2022-A00871-42
- Acronym
- YODA
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamdan S, Nguyen J, Abdoul H, Ollivier C, Treluyer JM, Courson F, Jungo S, Salmon B, Fron-Chabouis H, Smail-Faugeron V. Dog Therapy for Dental Care Among Autistic Children: A Randomized Trial. Pediatrics. 2026 Feb 1;157(2):e2025073469. doi: 10.1542/peds.2025-073469.
PubMed 41506515
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients
- ClinicalTrials.gov ID
- NCT05577234
- Acronym / sponsor ID
- YODA / APHP220662
- Conditions
- Autism
- Keywords
- Animal-assisted therapy, child, autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 13 Oct 2022 (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 purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism.
Detailed description
The particularity of some disabled patients, especially those with an autism spectrum disorder, is represented by anxiety, which can range from a slight tension to screaming or even extreme agitation. This behavior can make therapeutic management difficult, both for the patient and the caregiver. This is particularly true for oral health care, where the cooperation of the patient is essential. Conventional behavioral approaches, with implementation of a multitude of adaptive strategies, has a fundamental role to play. With disabled patients, these techniques are most often based on non-verbal or para-verbal communication rather than on linguistic procedures. In this context, an Animal Assisted Intervention could be of major help. The primary outcome is average child anxiety during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third session of care (without animal-assisted therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted intervention | Experimental | Other: Animal-assisted intervention, Behavioral: Venham scale modified by VeerkampThe dog accompanied by the zootherapist will participate in the care of the sessions. During these sessions, the dog will be brought into the child's presence in the waiting room until the end of the dental consultation. |
| Standard care | Other | Behavioral: Venham scale modified by VeerkampThe treatment sessions will only involve the use of conventional behavioural strategies. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Minors aged ≥ 6 to ≤ 17 years,
- Carriers of Autism Spectrum Disorder.
- Child with an average Venham scale score ≥ 3 at the end of the care of the inclusion session
- Who accept the presence of the dog
- Who declare having been in contact with a dog in the past
Key exclusion criteria (4 listed)
- Child with dog allergy
- Cynophobia
- Who claims never to have been exposed to a dog (allergy risk not assessed)
- Patient on AME
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 |
|---|---|---|
| Animal-assisted interventionThe dog accompanied by the zootherapist will participate in the care of sessions 1 and 2. During these two sessions, the dog will be present with the child in the waiting room until the end of the dental consultation. Session 3 will take place without the dog being present.The usual management with conventional behavioural strategies and possible administration of MEOPA will be implemented during the 3 treatment sessions. | Other | Animal-assisted intervention |
| Venham scale modified by VeerkampThe Venham scale modified by Veerkamp, based on observation of one's behaviour and used in current practice, ranges from 0 (relaxed) to 5 (totally disconnected from the reality of danger). | Behavioural | Animal-assisted intervention, Standard care |
Primary outcome
Average anxiety
Time frame: through study completion, an average of 3 months
Average anxiety of the child during the session assessed by the Venham scale modified by Veerkamp measured at the end of the third treatment session (without animal assisted intervention). Score on a scale : Min = 0 Max = 5 : 0 = relaxed, 1 = uneasy, 2 = tense, 3 = unwilling, 4 = very troubled, 5 = totally out of touch
4 secondary outcomes
Evaluate the success of the care session (complete achievement of the planned objective)
Time frame: at the end of each follow-up visit, on average 3 months
Validate the use of MEOPA administration
Time frame: at the end of each follow-up visit, on average 3 months
Assess the types of acts for which animal assisted intervention reduces the child's anxiety
Time frame: at the end of each follow-up visit, on average 3 months
Assessing the safety of animal assisted intervention for oral care
Time frame: at the end of each follow-up visit, on average 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Results publication: PubMed 41506515Hamdan S, Nguyen J, Abdoul H, Ollivier C, Treluyer JM, Courson F, Jungo S, Salmon B, Fron-Chabouis H, Smail-Faugeron V. Dog Therapy for Dental Care Among Autistic Children: A Randomized Trial. Pediatrics. 2026 Feb 1;157(2):e2025073469. doi: 10.1542/peds.2025-073469.
- 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. This study is not recruiting at the moment.
Jean-Marc TRELUYER, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted intervention and Venham scale modified by Veerkamp in people with Autism, run by Assistance Publique - Hôpitaux de Paris 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 4 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: finished, as of the sponsor's last update on 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average anxiety (time frame: through study completion, an average of 3 months). 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 NCT05577234, which also lists 1 linked publication.
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 11 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.