An interventional study of Familiarization sessions using clown therapy and Familiarization sessions with conventional methods in Autism Spectrum Disorder (ASD, sponsored by University of Milan. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Milan · Not applicable, Interventional, and Other
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 46 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Familiarization sessions with conventional methods
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.
Behavioral: Familiarization sessions using clown therapy
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.
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.
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.
Time frame: Baseline (first dental visit), Week 1, Week 2, and Week 3
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.
Time frame: 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).
Time frame: Week 3 (end of the third familiarization session)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 3 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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