Autism Spectrum Disorder (ASDNCT07906288
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
A study testing Familiarization sessions using clown therapy and Familiarization sessions with conventional methods in people with Autism Spectrum Disorder (ASD, run by University of Milan at 1 site in Italy.
Trial summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interaction, as well as repetitive and stereotyped behaviors. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- What is being tested?
- Familiarization sessions using clown therapy and Familiarization sessions with conventional methods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2026to 30 Mar 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children aged 6-14 years;
- Diagnosis of Autism Spectrum Disorder (ASD) Level II-III;
- Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 1-2 (uncooperative child);
- Failure to complete at least two steps of the dental examination protocol;
- Absence of coulrophobia (fear of clowns);
- Absence of dental emergencies requiring immediate treatment;
- Availability of a parent or caregiver to accompany the child to the familiarization sessions;
- Written informed consent signed by the parent or caregiver for participation in the study.
Who cannot join
- Diagnosis of Autism Spectrum Disorder (ASD) Level I;
- Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 3-4 (cooperative child);
- Completion of more than two steps of the dental examination protocol;
- Presence of coulrophobia (fear of clowns);
- Presence of dental emergencies requiring immediate treatment;
- Unavailability of a parent or caregiver to accompany the child to the familiarization sessions;
- Lack of written informed consent signed by the parent or caregiver for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dental Clinic G.Vogel, saint paul and charles hospital
Milan, Milan, 20142
Aesha Allam, Doctor, 3276218958, aesha.allam@unimi.it
About this study
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interaction, as well as repetitive and stereotyped behaviors. Home oral hygiene procedures are often resisted by children with ASD; consequently, maintaining an adequate level of oral hygiene can be challenging, leading to an increased risk of dental caries and gingivitis compared with children without ASD.
Children with ASD frequently experience difficulties attending dental appointments, as the dental setting falls outside their usual routine. Furthermore, the smells, sounds, and visual stimuli present in the dental environment may be overwhelming for a child with ASD, causing anxiety that can exacerbate stereotyped behaviors and self-injurious actions, thereby making completion of the dental examination difficult. Given the sensory processing challenges commonly experienced by children with ASD, it is essential that dental professionals are aware of these difficulties and adopt specific strategies to reduce anxiety and promote cooperation during dental visits. Despite the use of traditional behavioral techniques, such as desensitization, modeling, and the tell-show-do approach, the management of these patients remains challenging. Clown therapy, which has already demonstrated effectiveness in reducing anxiety and pain in pediatric hospital settings, represents a potentially innovative intervention in this context, although evidence regarding its use in children with special healthcare needs remains limited. The primary objective of this study is to evaluate the number of completed steps of a dental visit protocol, comparing a familiarization pathway conducted through clown therapy with a conventional familiarization pathway conducted by dental staff in patients with ASD.
Read more
The secondary objectives are to assess the level of cooperation during the familiarization sessions and to evaluate parent/caregiver satisfaction with the two proposed approaches.This study is designed as a pilot randomized controlled trial (RCT) with two parallel arms and a 1:1 allocation ratio.
A total of 46 children (23 per group) aged 6 to 14 years with a diagnosis of moderate to severe Autism Spectrum Disorder (ASD Level II-III) who are uncooperative during the initial dental examination (Frankl Behavior Rating Scale score 1-2) will be recruited from the Dental Clinic of San Paolo Hospital .
Eligible participants will be male or female children aged 6-14 years with a diagnosis of ASD Level II-III, a baseline Frankl score of 1-2 indicating non-cooperative behavior, inability to complete at least two steps of the dental examination, absence of coulrophobia (fear of clowns), absence of dental emergencies requiring immediate treatment, availability of a parent or caregiver to accompany the child to the familiarization sessions, and written informed consent provided by the parent or caregiver. Exclusion criteria include a diagnosis of ASD Level I, a baseline Frankl score of 3-4 indicating cooperative behavior, completion of more than two steps of the dental examination, presence of coulrophobia, dental emergencies requiring immediate treatment, lack of parental or caregiver availability for attendance at the familiarization sessions, or absence of written informed consent.
Following acquisition of written informed consent from the parent or caregiver and assent from the child whenever appropriate, participants will be randomized into one of two study groups. The control group will undergo a conventional familiarization pathway based on standard behavioral management techniques delivered by dental staff, whereas the intervention group will undergo a familiarization pathway involving clown therapy, conducted collaboratively by dental professionals and professional clown therapists from Fondazione Dottor Sorriso.
Both groups will attend three consecutive weekly sessions (T1-T3) following a gradual and non-coercive approach. For each participant, at the end of every session, a standardized data collection form will be completed to record the number of dental examination steps successfully completed and the level of cooperation. Upon completion of the three familiarization sessions, parents or caregivers in both study groups will be asked to complete a satisfaction questionnaire to evaluate their perceptions of the intervention received.
- Conditions
- Autism Spectrum Disorder (ASD
- Being tested
- Familiarization sessions using clown therapy, Familiarization sessions with conventional methods
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familiarization sessions using clown therapyBehavioural
The familiarization activities will be conducted by two dentists and medical clowns.
T1 ( Session 1): The session will be conducted exclusively by the medical clowns, who will perform a brief educational and playful show aimed at explaining the steps of a dental visit in an engaging manner, using toys. Interaction with the clowns through games and sketches will be encouraged. No direct intervention by the dentist or active involvement of the child will occur during this session.
T2 (Session 2): The session will involve interaction among the patient, the clown therapists, and the parent. The parent will be gradually engaged, while the dentist's intervention will be directed primarily toward thoward the clown therapists and/or the parent, maintaining an indirect approach toward the child.
T3 (Session 3): The session will include interaction with the medical clowns, intervention by the dentist directed toward the clowns and the parent, and finally direct involvement of the child.
Familiarization sessions with conventional methodsBehavioural
Patients will participate in three consecutive sessions (T1, T2, and T3), scheduled at weekly intervals. The familiarization activities will be conducted exclusively by two dentists, in the presence of at least one parent or legal guardian.
T1 (Session 1): Introduction to the dental operatory and dental chair using basic behavioral management techniques, including tell-show-do and desensitization. The instruments required for a dental examination (mouth mirror and dental explorer) will also be introduced.
T2 (Session 2): Repetition of the activities performed during T1, with a simulated dental examination carried out on the parent (modeling technique) to encourage patient cooperation.
T3 (Session 3): Following a brief review of the activities completed during T1 and T2, the patient will be invited to sit in the dental chair and undergo a clinical examination according to standard assessment procedures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group: familiarization sessions with dentists only | Other | Patients will participate in three consecutive sessions (T1, T2, and T3), scheduled at weekly intervals. The familiarization activities will be conducted exclusively by two dentists, in the presence of at least one parent or legal guardian.
T1 (Session 1): Introduction to the dental operatory and dental chair using basic behavioral management techniques, including tell-show-do and desensitization. The instruments required for a dental examination (mouth mirror and dental explorer) will also be introduced.
T2 (Session 2): Repetition of the activities performed during T1, with a simulated dental examination carried out on the parent (modeling technique) to encourage patient cooperation.
T3 (Session 3): Following a brief review of the activities completed during T1 and T2, the patient will be invited to sit in the dental chair and undergo a clinical examination according to standard assessment procedures. Receives: Behavioral: Familiarization sessions with conventional methods |
| Clown group: familiarization sessions with dentists and medical clowns | Experimental | The familiarization activities will be conducted by two dentists and medical clowns.
T1 ( Session 1): The session will be conducted exclusively by the medical clowns, who will perform a brief educational and playful show aimed at explaining the steps of a dental visit in an engaging manner, using toys. Interaction with the clowns through games and sketches will be encouraged. No direct intervention by the dentist or active involvement of the child will occur during this session.
T2 (Session 2): The session will involve interaction among the patient, the clown therapists, and the parent. The parent will be gradually engaged, while the dentist's intervention will be directed primarily toward thoward the clown therapists and/or the parent, maintaining an indirect approach toward the child.
T3 (Session 3): The session will include interaction with the medical clowns, intervention by the dentist directed toward the clowns and the parent, and finally direct involvement of the child. Receives: Behavioral: Familiarization sessions using clown therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of completed steps of the the dental visit
Total number of completed steps of the dental visit. The dental visit is divided into 8 steps: entering the room, sitting on the dental chair, reclining in the dental chair, accepting the dental operating light, opening the mouth, accepting an oral examination with gloves, and accepting the dental mirror and probe. The number of completed steps will be recorded at the first dental visit (baseline) and at each of the three familiarization sessions, each one week apart.
Measured: Baseline (first dental visit), Week 1, Week 2, and Week 3
Secondary outcomes (2)
The level of cooperation during the familiarization sessions, as assessed using the Frankl Behavior Rating Scale (Frankl Scale)
Level of cooperation during the familiarization sessions, assessed using the Frankl Behavior Rating Scale: 1 = definitely negative, 2 = negative, 3 = positive, 4 = definitely positive. Higher scores indicate a better outcome (greater cooperation). The coperation level will be assessed at the first dental visit (baseline) and at each of the three familiarization sessions, each one week apart.
Measured: Baseline (first dental visit), Week 1, Week 2, and Week 3
Caregivers' and/or parents' feedback (satisfaction) on the sessions
Caregivers' and/or parents' feedback (satisfaction) on the sessions, measured with an 8-item questionnaire administered at the end of the three familiarization sessions. Each item is rated on a Likert scale from 0 to 5: 0 = definitely disagree, 1 = disagree, 2 = neutral, 3 = agree, 4 = totally agree. Minimum score per item is 0 and maximum is 5. Higher scores indicate greater satisfaction (a better outcome).
Measured: Week 3 (end of the third familiarization session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aesha Allam, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906288
- Sponsor's protocol ID
- CET 225-2026
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07906288
- Acronym / sponsor ID
- CET 225-2026
- Conditions
- Autism Spectrum Disorder (ASD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interaction, as well as repetitive and stereotyped behaviors. Home oral hygiene procedures are often resisted by children with ASD; consequently, maintaining an adequate level of oral hygiene can be challenging, leading to an increased risk of dental caries and gingivitis compared with children without ASD.
Children with ASD frequently experience difficulties attending dental appointments, as the dental setting falls outside their usual routine. Furthermore, the smells, sounds, and visual stimuli present in the dental environment may be overwhelming for a child with ASD, causing anxiety that can exacerbate stereotyped behaviors and self-injurious actions, thereby making completion of the dental examination difficult. Given the sensory processing challenges commonly experienced by children with ASD, it is essential that dental professionals are aware of these difficulties and adopt specific strategies to reduce anxiety and promote cooperation during dental visits. Despite the use of traditional behavioral techniques, such as desensitization, modeling, and the tell-show-do approach, the management of these patients remains challenging. Clown therapy, which has already demonstrated effectiveness in reducing anxiety and pain in pediatric hospital settings, represents a potentially innovative intervention in this context, although evidence regarding its use in children with special healthcare needs remains limited. The primary objective of this study is to evaluate the number of completed steps of a dental visit protocol, comparing a familiarization pathway conducted through clown therapy with a conventional familiarization pathway conducted by dental staff in patients with ASD.
The secondary objectives are to assess the level of cooperation during the familiarization sessions and to evaluate parent/caregiver satisfaction with the two proposed approaches.This study is designed as a pilot randomized controlled trial (RCT) with two parallel arms and a 1:1 allocation ratio.
A total of 46 children (23 per group) aged 6 to 14 years with a diagnosis of moderate to severe Autism Spectrum Disorder (ASD Level II-III) who are uncooperative during the initial dental examination (Frankl Behavior Rating Scale score 1-2) will be recruited from the Dental Clinic of San Paolo Hospital .
Eligible participants will be male or female children aged 6-14 years with a diagnosis of ASD Level II-III, a baseline Frankl score of 1-2 indicating non-cooperative behavior, inability to complete at least two steps of the dental examination, absence of coulrophobia (fear of clowns), absence of dental emergencies requiring immediate treatment, availability of a parent or caregiver to accompany the child to the familiarization sessions, and written informed consent provided by the parent or caregiver. Exclusion criteria include a diagnosis of ASD Level I, a baseline Frankl score of 3-4 indicating cooperative behavior, completion of more than two steps of the dental examination, presence of coulrophobia, dental emergencies requiring immediate treatment, lack of parental or caregiver availability for attendance at the familiarization sessions, or absence of written informed consent.
Following acquisition of written informed consent from the parent or caregiver and assent from the child whenever appropriate, participants will be randomized into one of two study groups. The control group will undergo a conventional familiarization pathway based on standard behavioral management techniques delivered by dental staff, whereas the intervention group will undergo a familiarization pathway involving clown therapy, conducted collaboratively by dental professionals and professional clown therapists from Fondazione Dottor Sorriso.
Both groups will attend three consecutive weekly sessions (T1-T3) following a gradual and non-coercive approach. For each participant, at the end of every session, a standardized data collection form will be completed to record the number of dental examination steps successfully completed and the level of cooperation. Upon completion of the three familiarization sessions, parents or caregivers in both study groups will be asked to complete a satisfaction questionnaire to evaluate their perceptions of the intervention received.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group: familiarization sessions with dentists only | Other | Behavioral: Familiarization sessions with conventional methodsPatients will participate in three consecutive sessions (T1, T2, and T3), scheduled at weekly intervals. The familiarization activities will be conducted exclusively by two dentists, in the presence of at least one parent or legal guardian. T1 (Session 1): Introduction to the dental operatory and dental chair using basic behavioral management techniques, including tell-show-do and desensitization. The instruments required for a dental examination (mouth mirror and dental explorer) will also be introduced. T2 (Session 2): Repetition of the activities performed during T1, with a simulated dental examination carried out on the parent (modeling technique) to encourage patient cooperation. T3 (Session 3): Following a brief review of the activities completed during T1 and T2, the patient will be invited to sit in the dental chair and undergo a clinical examination according to standard assessment procedures. |
| Clown group: familiarization sessions with dentists and medical clowns | Experimental | Behavioral: Familiarization sessions using clown therapyThe familiarization activities will be conducted by two dentists and medical clowns. T1 ( Session 1): The session will be conducted exclusively by the medical clowns, who will perform a brief educational and playful show aimed at explaining the steps of a dental visit in an engaging manner, using toys. Interaction with the clowns through games and sketches will be encouraged. No direct intervention by the dentist or active involvement of the child will occur during this session. T2 (Session 2): The session will involve interaction among the patient, the clown therapists, and the parent. The parent will be gradually engaged, while the dentist's intervention will be directed primarily toward thoward the clown therapists and/or the parent, maintaining an indirect approach toward the child. T3 (Session 3): The session will include interaction with the medical clowns, intervention by the dentist directed toward the clowns and the parent, and finally direct involvement of the child. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female children aged 6-14 years;
- Diagnosis of Autism Spectrum Disorder (ASD) Level II-III;
- Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 1-2 (uncooperative child);
- Failure to complete at least two steps of the dental examination protocol;
- Absence of coulrophobia (fear of clowns);
Key exclusion criteria (7 listed)
- Diagnosis of Autism Spectrum Disorder (ASD) Level I;
- Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 3-4 (cooperative child);
- Completion of more than two steps of the dental examination protocol;
- Presence of coulrophobia (fear of clowns);
- Presence of dental emergencies requiring immediate treatment;
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 |
|---|---|---|
| Familiarization sessions using clown therapyThe familiarization activities will be conducted by two dentists and medical clowns. T1 ( Session 1): The session will be conducted exclusively by the medical clowns, who will perform a brief educational and playful show aimed at explaining the steps of a dental visit in an engaging manner, using toys. Interaction with the clowns through games and sketches will be encouraged. No direct intervention by the dentist or active involvement of the child will occur during this session. T2 (Session 2): The session will involve interaction among the patient, the clown therapists, and the parent. The parent will be gradually engaged, while the dentist's intervention will be directed primarily toward thoward the clown therapists and/or the parent, maintaining an indirect approach toward the child. T3 (Session 3): The session will include interaction with the medical clowns, intervention by the dentist directed toward the clowns and the parent, and finally direct involvement of the child. | Behavioural | Clown group: familiarization sessions with dentists and medical clowns |
| Familiarization sessions with conventional methodsPatients will participate in three consecutive sessions (T1, T2, and T3), scheduled at weekly intervals. The familiarization activities will be conducted exclusively by two dentists, in the presence of at least one parent or legal guardian. T1 (Session 1): Introduction to the dental operatory and dental chair using basic behavioral management techniques, including tell-show-do and desensitization. The instruments required for a dental examination (mouth mirror and dental explorer) will also be introduced. T2 (Session 2): Repetition of the activities performed during T1, with a simulated dental examination carried out on the parent (modeling technique) to encourage patient cooperation. T3 (Session 3): Following a brief review of the activities completed during T1 and T2, the patient will be invited to sit in the dental chair and undergo a clinical examination according to standard assessment procedures. | Behavioural | Conventional group: familiarization sessions with dentists only |
Primary outcome
Total number of completed steps of the the dental visit
Time frame: Baseline (first dental visit), Week 1, Week 2, and Week 3
Total number of completed steps of the dental visit. The dental visit is divided into 8 steps: entering the room, sitting on the dental chair, reclining in the dental chair, accepting the dental operating light, opening the mouth, accepting an oral examination with gloves, and accepting the dental mirror and probe. The number of completed steps will be recorded at the first dental visit (baseline) and at each of the three familiarization sessions, each one week apart.
2 secondary outcomes
The level of cooperation during the familiarization sessions, as assessed using the Frankl Behavior Rating Scale (Frankl Scale)
Time frame: Baseline (first dental visit), Week 1, Week 2, and Week 3
Caregivers' and/or parents' feedback (satisfaction) on the sessions
Time frame: Week 3 (end of the third familiarization session)
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familiarization sessions using clown therapy and Familiarization sessions with conventional methods in people with Autism Spectrum Disorder (ASD, run by University of Milan at 1 site in Italy.
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 8 inclusion and 7 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 30 Oct 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of completed steps of the the dental visit (time frame: Baseline (first dental visit), Week 1, Week 2, and Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.