AutismSRINCT06974240
Social Robotics for Autism
A study testing Experimental Group 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
Socio-pragmatics focuses on the study of language in the context of social interactions. It explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2024to 30 Nov 2024
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 8 and 13 years
- Clinical diagnosis of ASD according to DSM-5 criteria by a licensed child neuropsychiatrist
- Verbal and performance IQ > 75 and total IQ > 85, assessed with the WISC-IV
- No current aggressive behavior or severe oppositional tendencies
- No hearing, vision, or physical impairments that could interfere with participation
- Not currently taking any psychotropic medications
Who cannot join
- Absence of a clinical diagnosis of ASD based on DSM-5 criteria
- Verbal or performance IQ ≤ 75, or total IQ ≤ 85 as assessed by WISC-IV
- Presence of aggressive behavior or severe oppositional tendencies
- Hearing, vision, or physical impairments that could hinder participation in the intervention
- Current use of psychotropic medications
Trial locations and contacts
1 site in 1 country.
Italy1 site
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
About this study
Official title: Social Robotics Intervention for Improving Socio-Pragmatic Skills in Autism: A Randomized Controlled Trial
Socio-pragmatics focuses on the study of language in the context of social interactions. It explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. Socio-pragmatics analyzes linguistic and nonlinguistic behaviors, such as gestures, facial expressions, tone of voice, and posture, to understand intended meaning, social implications, and shared communicative norms. Children with autism often present difficulties in social-pragmatic skills.
The integration of advanced technologies can play a crucial role in innovative approaches to the development of this skill.
In this experimental protocol, an attempt will be made to demonstrate the effectiveness of training through the use of social robots by comparing the performance of an ASD group performing a treatment using social robots with a control group performing the same in a traditional manner.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Experimental Group, control group
- Keywords
- autism, social robot, social pragmatic skills, intervention, social skills, educational technologies
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
The training sessions were carried out following a strict order. The first phase was dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, videos were shown and participants answered targeted questions asked by the Nao Robot to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, which re-enacted the situations seen in the videos, involving all the members of the group in turn. During the last phase, participants were asked to share experiences in their lives in which they had used or could have used the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.
control groupOther
The entire intervention was carried out in a group entirely mediated by an operator without the use of a social robot. The first phase is dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, stories were read and participants answered target questions to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, in which all members of the group participated in turn, recalling the situations seen in the videos. During the last phase, participants were asked to share experiences from their lives in which they used or could use the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group with social robot | Experimental | Ten children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. They will be randomly assigned to either the control group or the experimental group. Participants in the experimental group will undergo an intervention aimed at developing and/or enhancing socio-pragmatic skills through the mediation of a social robot. Receives: Other: Experimental Group |
| Control Group | Other | Ten children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. Children in the control group will follow the same protocol of Experimental Group delivered through a therapist-led group format. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV)
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
Measured: Baseline assessment at Day 1 (prior to intervention); the test requires approximately 56-80 minutes to complete.
Language Pragmatic Abilities (APL) -MEDEA
The APL MEDEA is a standardized assessment tool specifically designed to evaluate socio-pragmatic skills in individuals aged 5 to 14 years. This test measures various aspects of pragmatic language skills that are essential for effective communication within social contexts.
The main objective of the APL MEDEA is to assess pragmatic language skills employed during everyday interactions, including the understanding and appropriate use of language in various social situations, recognition of social cues, and effective conversational strategies. The total score ranges from 0 to 68.
Measured: Baseline assessment at Day 1 (pre-intervention) and post-intervention assessment at 3 months (at the end of the intervention); each test session lasts approximately 30-45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Jan 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 20 participants (actual)
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, Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974240
- Sponsor's protocol ID
- CNR-IRIB-PRO-2025-003
- Acronym
- SRI
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holeva V, Nikopoulou VA, Lytridis C, Bazinas C, Kechayas P, Sidiropoulos G, Papadopoulou M, Kerasidou MD, Karatsioras C, Geronikola N, Papakostas GA, Kaburlasos VG, Evangeliou A. Effectiveness of a Robot-Assisted Psychological Intervention for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2024 Feb;54(2):577-593. doi: 10.1007/s10803-022-05796-5. Epub 2022 Nov 4.
PubMed 36331688Taheri, A., Shariati, A., Heidari, R., Shahab, M., Alemi, M., & Meghdari, A. (2021). Impacts of using a social robot to teach music to children with low-functioning autism. Paladyn, Journal of Behavioral Robotics, 12(1), 256-275.
So WC, Cheng CH, Law WW, Wong T, Lee C, Kwok FY, Lee SH, Lam KY. Robot dramas may improve joint attention of Chinese-speaking low-functioning children with autism: stepped wedge trials. Disabil Rehabil Assist Technol. 2023 Feb;18(2):195-204. doi: 10.1080/17483107.2020.1841836. Epub 2020 Nov 13.
PubMed 33186058
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Robotics Intervention for Improving Socio-Pragmatic Skills in Autism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06974240
- Acronym / sponsor ID
- SRI / CNR-IRIB-PRO-2025-003
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, social robot, social pragmatic skills, intervention, social skills, educational technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 May 2025 (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.
Socio-pragmatics focuses on the study of language in the context of social interactions. It explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. Socio-pragmatics analyzes linguistic and nonlinguistic behaviors, such as gestures, facial expressions, tone of voice, and posture, to understand intended meaning, social implications, and shared communicative norms. Children with autism often present difficulties in social-pragmatic skills.
The integration of advanced technologies can play a crucial role in innovative approaches to the development of this skill.
In this experimental protocol, an attempt will be made to demonstrate the effectiveness of training through the use of social robots by comparing the performance of an ASD group performing a treatment using social robots with a control group performing the same in a traditional manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group with social robot | Experimental | Other: Experimental GroupTen children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. They will be randomly assigned to either the control group or the experimental group. Participants in the experimental group will undergo an intervention aimed at developing and/or enhancing socio-pragmatic skills through the mediation of a social robot. |
| Control Group | Other | Other: control groupTen children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. Children in the control group will follow the same protocol of Experimental Group delivered through a therapist-led group format. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 8 and 13 years
- Clinical diagnosis of ASD according to DSM-5 criteria by a licensed child neuropsychiatrist
- Verbal and performance IQ > 75 and total IQ > 85, assessed with the WISC-IV
- No current aggressive behavior or severe oppositional tendencies
- No hearing, vision, or physical impairments that could interfere with participation
Key exclusion criteria (5 listed)
- Absence of a clinical diagnosis of ASD based on DSM-5 criteria
- Verbal or performance IQ ≤ 75, or total IQ ≤ 85 as assessed by WISC-IV
- Presence of aggressive behavior or severe oppositional tendencies
- Hearing, vision, or physical impairments that could hinder participation in the intervention
- Current use of psychotropic medications
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 |
|---|---|---|
| Experimental GroupThe training sessions were carried out following a strict order. The first phase was dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, videos were shown and participants answered targeted questions asked by the Nao Robot to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, which re-enacted the situations seen in the videos, involving all the members of the group in turn. During the last phase, participants were asked to share experiences in their lives in which they had used or could have used the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week. | Other | Experimental Group with social robot |
| control groupThe entire intervention was carried out in a group entirely mediated by an operator without the use of a social robot. The first phase is dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, stories were read and participants answered target questions to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, in which all members of the group participated in turn, recalling the situations seen in the videos. During the last phase, participants were asked to share experiences from their lives in which they used or could use the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week. | Other | Control Group |
Primary outcome
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV)
Time frame: Baseline assessment at Day 1 (prior to intervention); the test requires approximately 56-80 minutes to complete.
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
Language Pragmatic Abilities (APL) -MEDEA
Time frame: Baseline assessment at Day 1 (pre-intervention) and post-intervention assessment at 3 months (at the end of the intervention); each test session lasts approximately 30-45 minutes.
The APL MEDEA is a standardized assessment tool specifically designed to evaluate socio-pragmatic skills in individuals aged 5 to 14 years. This test measures various aspects of pragmatic language skills that are essential for effective communication within social contexts. The main objective of the APL MEDEA is to assess pragmatic language skills employed during everyday interactions, including the understanding and appropriate use of language in various social situations, recognition of social cues, and effective conversational strategies. The total score ranges from 0 to 68.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 36331688Holeva V, Nikopoulou VA, Lytridis C, Bazinas C, Kechayas P, Sidiropoulos G, Papadopoulou M, Kerasidou MD, Karatsioras C, Geronikola N, Papakostas GA, Kaburlasos VG, Evangeliou A. Effectiveness of a Robot-Assisted Psychological Intervention for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2024 Feb;54(2):577-593. doi: 10.1007/s10803-022-05796-5. Epub 2022 Nov 4.
- BackgroundTaheri, A., Shariati, A., Heidari, R., Shahab, M., Alemi, M., & Meghdari, A. (2021). Impacts of using a social robot to teach music to children with low-functioning autism. Paladyn, Journal of Behavioral Robotics, 12(1), 256-275.
- Background: PubMed 33186058So WC, Cheng CH, Law WW, Wong T, Lee C, Kwok FY, Lee SH, Lam KY. Robot dramas may improve joint attention of Chinese-speaking low-functioning children with autism: stepped wedge trials. Disabil Rehabil Assist Technol. 2023 Feb;18(2):195-204. doi: 10.1080/17483107.2020.1841836. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No
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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.
Flavia Marino principal investigator
Italy 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 Experimental Group 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV) (time frame: Baseline assessment at Day 1 (prior to intervention); the test requires approximately 56-80 minutes to complete.). The study lists 2 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 NCT06974240, which also lists 3 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 15 May 2025.