Exploring Theatrical Expressive Tasks for Children With ASD

NCT ID: NCT06468072

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-06-30

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.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Children with autism

The experimental group consists of 10 children diagnosed with autism who voluntarily attend the CNR-IRIB in Messina. The sample is aged between 7 and 11 years with severity level 1 (minimum support required)

Group Type: EXPERIMENTAL

Expressivity protocol for children with autism

Intervention Type: OTHER

The activities proposed by this protocol stimulate different expressive skills, which are often lacking in people with autism. For this reason, the protocol is based on the strengthening of the following skills: perception of the body in movement in the space (4 sessions), the expressiveness of the body in its entirety (4 sessions), breathing and the use of the voice to express emotions in relation to the environment (4 sessions), rhythm and movement, to develop motor coordination and the expressiveness of movements (4 sessions). The protocol consists of 16 sessions: a weekly group session lasting one hour.

Non-autistic children

The comparison group consists of 10 non-autistic children with no other diagnosis, who voluntarily attend the CNR-IRIB in Messina. The sample is between 7 and 11 years old.

Group Type: OTHER

Expressivity protocol for non-autistic children

Intervention Type: OTHER

The activities proposed by this protocol stimulate different expressive skills. The protocol is based on the strengthening of the following skills: perception of the body in movement in space (4 sessions), the expressiveness of the body in its entirety (4 sessions), breathing and the use of the voice to express emotions in relation to the environment (4 sessions), rhythm and movement, to develop motor coordination and the expressiveness of movements (4 sessions). The protocol consists of 16 sessions: a weekly group session lasting one hour.

Interventions

Expressivity protocol for children with autism

The activities proposed by this protocol stimulate different expressive skills, which are often lacking in people with autism. For this reason, the protocol is based on the strengthening of the following skills: perception of the body in movement in the space (4 sessions), the expressiveness of the body in its entirety (4 sessions), breathing and the use of the voice to express emotions in relation to the environment (4 sessions), rhythm and movement, to develop motor coordination and the expressiveness of movements (4 sessions). The protocol consists of 16 sessions: a weekly group session lasting one hour.

Intervention Type: OTHER

Expressivity protocol for non-autistic children

The activities proposed by this protocol stimulate different expressive skills. The protocol is based on the strengthening of the following skills: perception of the body in movement in space (4 sessions), the expressiveness of the body in its entirety (4 sessions), breathing and the use of the voice to express emotions in relation to the environment (4 sessions), rhythm and movement, to develop motor coordination and the expressiveness of movements (4 sessions). The protocol consists of 16 sessions: a weekly group session lasting one hour.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Messina, Italy

OTHER

Sponsor Role: collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Flavia Marino

Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Locations

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Flavia Marino

Role: CONTACT

flavia.marino@irib.cnr.it

+393395798263

Maria valeria Maiorana

Role: CONTACT

mariavaleria.maiorana@irib.cnr.it

Facility Contacts

Flavia Marino

Role: primary

flavia.marino@irib.cnr.it

+393395798263

Maria Valeria Maiorana

Role: backup

mariavaleria.maiorana@irib.cnr.it

+393285856656

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 30078460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28741680 (View on PubMed)

Paul, R., & Simmons, E. (2019). Communication and its development in autism spectrum disorders. In Autism and Pervasive Developmental Disorders.

Reference Type: BACKGROUND

Other Identifiers

CNR-IRIB-PRO-2024-008

Identifier Type: -

Identifier Source: org_study_id