Clinical trial NCT06468072: Exploring Theatrical Expressive Tasks for Children With ASD
Official title: Exploring the Impact of Theatrical Expressive Tasks in Children With Autism Spectrum Disorder (ASD).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
children
expressiveness
theater
technology
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2024-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Profiling Elements of Prosodic Systems in Children (PEPS-C)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.
measure: Pragmatic Skills in the Medea Language (APL MEDEA)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change
measure: Test for understanding emotions (TEC)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.
measure: Movement Assessment Battery for Children - Second Edition (ABC-Movement - 2)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.
measure: Children's Communication Checklist - Second Edition (CCC-2)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.T
measure: Social Responsiveness Scale (SRS)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.
measure: Khymeia Virtual Reality Rehabilitation System (VRRS)
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change.
measure: NEuroPSYcology second edition (NEPSY-II) evaluations
timeFrame: The test will be scheduled pre intervention (T0) and at the study conclusion, about 1 year (T1). The T0 and T1 evaluations were conducted to determine whether the protocols carried out made a change. The test needs about 120-180 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zanchi, P., Peppé, S., & Zampini, L. (2022). Prosodic development from 4 to 10 years: Data from the Italian adaptation of the PEPS-C. Speech Communication, 144, 10-19. https://doi.org/10.1016/j.specom.2022.08.007
citation: Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
citation: Mandy W, Wang A, Lee I, Skuse D. Evaluating social (pragmatic) communication disorder. J Child Psychol Psychiatry. 2017 Oct;58(10):1166-1175. doi: 10.1111/jcpp.12785. Epub 2017 Jul 25.
citation: Paul, R., & Simmons, E. (2019). Communication and its development in autism spectrum disorders. In Autism and Pervasive Developmental Disorders.