Clown therapy to help kids with autism sit for dental visits

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares familiarization sessions using clown therapy with traditional familiarization approaches in children with autism who struggle with dental visits. Eligible participants are 6-14 year olds with ASD Level II-III who are initially uncooperative and unable to complete parts of the dental exam. Outcomes focus on cooperation during the dental examination and progression through the protocol. The study is conducted at a Milan dental clinic, led by the University of Milan, with caregiver involvement required.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Dental Clinic G.Vogel, saint paul and charles hospital
  Milan, Milan, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• Cardiorespiratory and muscular fitness in children with obesity and autism

  This study tests whether cardiorespiratory fitness and handgrip strength differ between children with obesity who have autism and those who do not, and how these fitness measures relate to body size, composition, and cardiometabolic health.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT07804680

• Transitional Intervention for Hyperacusis in Autism

  Aiming to see if a transitional sound-therapy approach can help adults with autism tolerate everyday sounds better and reduce loudness-related distress.

  Recruiting University of Central Florida · Orlando, Florida and 1 other locations · NCT07798297

• Museum visits to support social and emotional well‑being in autistic adults

  This study tests whether visiting the National Taiwan Museum can help improve social participation and well-being for autistic adults aged 18–50.

  Recruiting National Taiwan University Hospital · Taipei · NCT07768332

• AdiaVita and glutathione for autism in kids and teens

  This study tests whether adding AdiaVita (cord-blood stem cells and exosomes) to glutathione helps improve ASD symptoms in children and other participants compared with glutathione alone.

  Recruiting at 2 sites Phase 1 Greater Atlanta Integrative Pediatrics · Roswell, Georgia and 1 other locations · NCT07622316

• Online test of BlinkLab Dx1 for autism in kids aged 2–11

  This study tests whether the BlinkLab Dx1 smartphone app can help identify autism in children aged 2 to 11 by comparing app-based measurements with prior clinical diagnoses.

  Recruiting Blinklab Limited · Princeton, New Jersey · NCT07590973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.