Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 46
• From 10 Nov 2026 to the primary completion date, 20 Feb 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 6 years to 14 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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