AutismNCT06468072
Exploring Theatrical Expressive Tasks for Children With ASD
A study testing Expressivity protocol for children with autism and Expressivity protocol for non-autistic children in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Expressivity protocol for children with autism and Expressivity protocol for non-autistic children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism spectrum disorder;
- Age between 6 and 11 years;
- IQ over 80 assessed by means of WISC-IV.
Who cannot join
- Presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Maria valeria Maiorana contact
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Maria Valeria Maiorana, +393285856656, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Exploring the Impact of Theatrical Expressive Tasks in Children With Autism Spectrum Disorder (ASD).
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
- Being tested
- Expressivity protocol for children with autism, Expressivity protocol for non-autistic children
- Keywords
- autism, children, expressiveness, theater, technology
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressivity protocol for children with autismOther
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.
Expressivity protocol for non-autistic childrenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with autism | Experimental | 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) Receives: Other: Expressivity protocol for children with autism |
| Non-autistic children | Other | 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. Receives: Other: Expressivity protocol for non-autistic children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling Elements of Prosodic Systems in Children (PEPS-C)
Profiling Elements of Prosody in Speech-Communication (PEPS-C) is a semi-automated test battery for assessing receptive and expressive prosody skills. It has been used in several studies of the speech and understanding of children with high-functioning autism/Asperger's syndrome (see Prosody and autism spectrum conditions). It is intended for use by language teachers, clinicians and researchers in assessing prosody in any conditions in both children and adults.
PEPS-C comprises 14 tasks, addressing receptive and expressive skills in parallel. The tasks are at two levels, examining prosodic function and prosodic form respectively. The assessment of skills at two levels helps to determine the level at which a testee has a problem with prosody, thus enabling better targeting of intervention. The range score is min 0 -max 192.
Measured: 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.
Pragmatic Skills in the Medea Language (APL MEDEA)
APL Medea is an assessment battery for pragmatic language skills developed at the Cognitive Psychology and Neuropsychology Service of the IRCCS 'Eugenio Medea'.
Structure:
Metaphors (M), divided into Verbal Metaphors (MV) and Figurative Metaphors (MF): investigates the ability to understand metaphorical language.
Comprehension of implicit meaning (CSI): assesses the ability to draw inferences about non-explicit content, range scores min 0 -max 72.
Comics (F): assesses the ability to understand and respect the dialogic structure in a communication, range scores min 0 -max 72.
Situations (S): assesses the ability to understand and appropriate the meaning assumed by particular expressions in social interaction, range scores min 0 -max 72.
The Colour Game (GC): assesses the ability to use language in a referential manner and use skills related to "Theory of Mind", range scores min 0 -max 72.
Measured: 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
Test for understanding emotions (TEC)
This test assesses the presence and development of emotional competence in children aged 3 to 11 years.
The test consists of 23 numbered cardboard plates. The first five boards depict four different emotional expressions each, alternating randomly. For each of them, the child is asked to identify a specific emotion. The structure of the remaining boards is instead unique: for each component, the upper part of the board represents a small story with emotional content, where the face of the protagonist is left blank. The lower part, represents four different emotional expressions, from which the child is asked to choose the corresponding one. The administration is individual.
From the application of the instrument, the authors came to the identification of a meta-emotional competence divided into three developmental areas categorisation of emotions in relation to their nature, understanding of the causes of emotions, control of emotions. The range score is min -0,3 - max 3,78.
Measured: 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.
Movement Assessment Battery for Children - Second Edition (ABC-Movement - 2)
The Movement ABC-2 battery identifies and describes the movement difficulties of children and adolescents from 3 to 16 years of age. The battery enables assessment and intervention planning in line with the bio-psycho-social model of human functioning. The Movement ABC-2 battery consists of 3 components:
A standardized test consisting of 24 tests divided into groups of 8 tasks for 3 age groups (3-6; 7-10; 11-16), for 3 competence areas (Manual Dexterity, Aiming and Grasping, Balance). In addition to the total score, it is also possible to obtain separate scores for the three competence areas. The range score is min 1- max 19.
An observational checklist consisting of 43 items divided into three sections, it must be completed by an adult who has the opportunity to observe the child in his/her daily motor activities.
A manual checklist that describes the ecological approach to intervention for children with movement difficulties.
Measured: 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.
Children's Communication Checklist - Second Edition (CCC-2)
The CCC-2 is a test that assesses the presence of communicative problems of a pragmatic nature that are difficult to assess with traditional tests. It consists of 70 multiple-choice items divided into 10 scales each containing seven items. For each scale, five items describe difficulties and two items describe strengths. The respondent is asked to rate the frequency with which different behaviors occur.
The scales are as follows: Eloquence, Syntax, Semantics, Coherence, Inappropriate beginning, Stereotyped language, Use of context, Non-verbal communication, Social relations, Interests (range score min 1 - max 280) Using these scales, two global scores can be calculated, the Global Communication Score (GCC) and the Global Social Interaction Discrepancy Score (SIDC).
The questionnaire is completed by an adult who has regular contact with the child or young person, preferably a parent.
Measured: 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
Social Responsiveness Scale (SRS)
The SRS assesses reciprocal social behavior, communication and repetitive and stereotyped behavior characteristic of autism spectrum disorders in subjects between 4 and 18 years.
A total score gives a measure of the severity of the social deficit and allows comparisons between different settings and assessors. The SRS is divided in the following subscales.
Social awareness: ability to pick up social cues (range scores min 30- max ≥ 90).
Social cognition: ability to interpret social signals once they have been perceived (range scores min 30-max ≥ 90).
Social communication: includes expressive social communication (range scores min 30-max ≥ 90).
Social motivation: indicates the extent to which a subject is generally motivated to engage in social-interpersonal behavior (range scores min 30-max ≥ 90).
Autistic mannerisms: include stereotyped behavior or highly restricted interests characteristic of autism (range scores min 30-max ≥ 90).
Measured: 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.
Khymeia Virtual Reality Rehabilitation System (VRRS)
Advanced software for analyzing facial expressions, it allows artificial intelligence technologies to accurately identify and interpret a broad spectrum of human emotions, recording facial movements, including those of the mouth, eyes and eyebrows, as well as the static balance of each child participating in the study.
Measured: 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.
NEuroPSYcology second edition (NEPSY-II) evaluations
Secondary Outcome Measure Description. NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. Neuropsychology II Edition (NESPY)' s Theory of Mind (ToM) subtest, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. The test will be given to children pre- and post-intervention.
The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468072
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-008
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 30078460Mandy 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.
PubMed 28741680Paul, R., & Simmons, E. (2019). Communication and its development in autism spectrum disorders. In Autism and Pervasive Developmental Disorders.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Theatrical Expressive Tasks in Children With Autism Spectrum Disorder (ASD).
- ClinicalTrials.gov ID
- NCT06468072
- Acronym / sponsor ID
- CNR-IRIB-PRO-2024-008
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, children, expressiveness, theater, technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with autism | Experimental | Other: Expressivity protocol for children with autismThe 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) |
| Non-autistic children | Other | Other: Expressivity protocol for non-autistic childrenThe 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of autism spectrum disorder;
- Age between 6 and 11 years;
- IQ over 80 assessed by means of WISC-IV.
Key exclusion criteria (1 listed)
- Presence of other medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressivity protocol for children with autismThe 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. | Other | Children with autism |
| Expressivity protocol for non-autistic childrenThe 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. | Other | Non-autistic children |
Primary outcome
Profiling Elements of Prosodic Systems in Children (PEPS-C)
Time frame: 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.
Profiling Elements of Prosody in Speech-Communication (PEPS-C) is a semi-automated test battery for assessing receptive and expressive prosody skills. It has been used in several studies of the speech and understanding of children with high-functioning autism/Asperger's syndrome (see Prosody and autism spectrum conditions). It is intended for use by language teachers, clinicians and researchers in assessing prosody in any conditions in both children and adults. PEPS-C comprises 14 tasks, addressing receptive and expressive skills in parallel. The tasks are at two levels, examining prosodic function and prosodic form respectively. The assessment of skills at two levels helps to determine the level at which a testee has a problem with prosody, thus enabling better targeting of intervention. The range score is min 0 -max 192.
Pragmatic Skills in the Medea Language (APL MEDEA)
Time frame: 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
APL Medea is an assessment battery for pragmatic language skills developed at the Cognitive Psychology and Neuropsychology Service of the IRCCS 'Eugenio Medea'. Structure: Metaphors (M), divided into Verbal Metaphors (MV) and Figurative Metaphors (MF): investigates the ability to understand metaphorical language. Comprehension of implicit meaning (CSI): assesses the ability to draw inferences about non-explicit content, range scores min 0 -max 72. Comics (F): assesses the ability to understand and respect the dialogic structure in a communication, range scores min 0 -max 72. Situations (S): assesses the ability to understand and appropriate the meaning assumed by particular expressions in social interaction, range scores min 0 -max 72. The Colour Game (GC): assesses the ability to use language in a referential manner and use skills related to "Theory of Mind", range scores min 0 -max 72.
Test for understanding emotions (TEC)
Time frame: 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.
This test assesses the presence and development of emotional competence in children aged 3 to 11 years. The test consists of 23 numbered cardboard plates. The first five boards depict four different emotional expressions each, alternating randomly. For each of them, the child is asked to identify a specific emotion. The structure of the remaining boards is instead unique: for each component, the upper part of the board represents a small story with emotional content, where the face of the protagonist is left blank. The lower part, represents four different emotional expressions, from which the child is asked to choose the corresponding one. The administration is individual. From the application of the instrument, the authors came to the identification of a meta-emotional competence divided into three developmental areas categorisation of emotions in relation to their nature, understanding of the causes of emotions, control of emotions. The range score is min -0,3 - max 3,78.
Movement Assessment Battery for Children - Second Edition (ABC-Movement - 2)
Time frame: 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 Movement ABC-2 battery identifies and describes the movement difficulties of children and adolescents from 3 to 16 years of age. The battery enables assessment and intervention planning in line with the bio-psycho-social model of human functioning. The Movement ABC-2 battery consists of 3 components: A standardized test consisting of 24 tests divided into groups of 8 tasks for 3 age groups (3-6; 7-10; 11-16), for 3 competence areas (Manual Dexterity, Aiming and Grasping, Balance). In addition to the total score, it is also possible to obtain separate scores for the three competence areas. The range score is min 1- max 19. An observational checklist consisting of 43 items divided into three sections, it must be completed by an adult who has the opportunity to observe the child in his/her daily motor activities. A manual checklist that describes the ecological approach to intervention for children with movement difficulties.
Children's Communication Checklist - Second Edition (CCC-2)
Time frame: 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
The CCC-2 is a test that assesses the presence of communicative problems of a pragmatic nature that are difficult to assess with traditional tests. It consists of 70 multiple-choice items divided into 10 scales each containing seven items. For each scale, five items describe difficulties and two items describe strengths. The respondent is asked to rate the frequency with which different behaviors occur. The scales are as follows: Eloquence, Syntax, Semantics, Coherence, Inappropriate beginning, Stereotyped language, Use of context, Non-verbal communication, Social relations, Interests (range score min 1 - max 280) Using these scales, two global scores can be calculated, the Global Communication Score (GCC) and the Global Social Interaction Discrepancy Score (SIDC). The questionnaire is completed by an adult who has regular contact with the child or young person, preferably a parent.
Social Responsiveness Scale (SRS)
Time frame: 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 SRS assesses reciprocal social behavior, communication and repetitive and stereotyped behavior characteristic of autism spectrum disorders in subjects between 4 and 18 years. A total score gives a measure of the severity of the social deficit and allows comparisons between different settings and assessors. The SRS is divided in the following subscales. Social awareness: ability to pick up social cues (range scores min 30- max ≥ 90). Social cognition: ability to interpret social signals once they have been perceived (range scores min 30-max ≥ 90). Social communication: includes expressive social communication (range scores min 30-max ≥ 90). Social motivation: indicates the extent to which a subject is generally motivated to engage in social-interpersonal behavior (range scores min 30-max ≥ 90). Autistic mannerisms: include stereotyped behavior or highly restricted interests characteristic of autism (range scores min 30-max ≥ 90).
Khymeia Virtual Reality Rehabilitation System (VRRS)
Time frame: 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.
Advanced software for analyzing facial expressions, it allows artificial intelligence technologies to accurately identify and interpret a broad spectrum of human emotions, recording facial movements, including those of the mouth, eyes and eyebrows, as well as the static balance of each child participating in the study.
NEuroPSYcology second edition (NEPSY-II) evaluations
Time frame: 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 Outcome Measure Description. NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. Neuropsychology II Edition (NESPY)' s Theory of Mind (ToM) subtest, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. The test will be given to children pre- and post-intervention. The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- BackgroundZanchi, 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
- Background: PubMed 30078460Lord 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.
- Background: PubMed 28741680Mandy 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.
- BackgroundPaul, R., & Simmons, E. (2019). Communication and its development in autism spectrum disorders. In Autism and Pervasive Developmental Disorders.
- Individual participant dataSharing planned: No
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Sleep, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria valeria Maiorana contact
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressivity protocol for children with autism and Expressivity protocol for non-autistic children in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Marino (+393395798263, flavia.marino@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiling Elements of Prosodic Systems in Children (PEPS-C) (time frame: 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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468072, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.