NCT06468072 Exploring Theatrical Expressive Tasks for Children With ASD
| NCT ID | NCT06468072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-05-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Autism Spectrum Disorder (ASD), according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders- V Edition (DSM-5), is a disorder involving (a) persistent deficits in social communication, social interaction and (b) patterns of restricted and stereotyped behavior and/or interests and/or activities. Specifically, impairment in social interaction manifests itself in different areas of individual functioning and through various facets: social-emotional reciprocity, poor understanding of social rules, reduced sharing of interests, emotions or feelings, reduced or absent theory of mind, inability to initiate or respond to social interactions (turn-taking in conversation), and difficulties in the use of communication. Facial expressions, vocal intonation, postures and gestures are crucial components of non-verbal communication that play a fundamental role in social-communicative functions. However, people with ASD may show significant deficits in these forms of expression, negatively affecting the ability to generate an appropriate social response, which is essential for initiating and maintaining social interactions. Children with ASD tend to avoid eye contact with others and show little or no interest in people, often looking past them or away from them. This behavior contributes to presenting them as "markedly aloof and distant". The aim of the study is to explore the effect of specific expressive tasks, conducted by highly qualified personnel, in a group setting, by means of targeted theatrical activities. These activities include exercises focusing on the use of voice and posture, the variety of vocal intonations and the harmonization between verbal production and facial expressiveness. In the context of this study, 20 children will be involved, divided into an experimental group and a control group. The experimental group will include 10 children with ASD who voluntarily participate in activities organized by the IRIB-CNR of Messina. These children, aged between 6 and 11 years, present a medium-high level of cognitive functioning, as assessed by the Wechsler Intelligence Scale for Children- IV Edition (WISC-IV) cognitive test. In parallel, the control group will consist of 10 normo-typical children, selected from the Istituto Comprensivo San Francesco di Paola of Messina, having the same age group, who will not participate in the experimental activities.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of autism spectrum disorder; * Age between 6 and 11 years; * IQ over 80 assessed by means of WISC-IV. Exclusion Criteria: * Presence of other medical disorders
Contact & Investigator
Flavia Marino
PRINCIPAL INVESTIGATOR
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Frequently Asked Questions
Who can join the NCT06468072 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06468072 currently recruiting?
Yes, NCT06468072 is actively recruiting participants. Contact the research team at flavia.marino@irib.cnr.it for enrollment information.
Where is the NCT06468072 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT06468072 clinical trial?
NCT06468072 is sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. The principal investigator is Flavia Marino at Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR). The trial plans to enroll 20 participants.