Autism Spectrum DisorderNCT06179953
Emotional Skills Training with Social Robot
A study testing NAO intervention and Traditional intervention in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns. In particular, emotional regulation is a central developmental skill. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NAO intervention and Traditional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2023to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Language in sentences
- use of connectors
- ability to narrate events not present
- ADOS level: module 2
- Griffiths: QS>75
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, Italy, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Giovanni Pioggia, +393203390892, giovanni.pioggia@irib.cnr.it
About this study
Official title: Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills
Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.
In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.
Read more
Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).
The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NAO intervention, Traditional intervention
- Keywords
- autism, children, emotional skills, social robot
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAO interventionOther
The protocol is divided into 4 stages:
- EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions.
- EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented.
- DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thought to an emotion.
- LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The robot provides instructions and if the child requests it, it elects prompts.
Traditional interventionOther
The protocol is divided into 4 stages:
- EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions.
- EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented.
- DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thought to an emotion.
- LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The therapist provides instructions, and if the child has difficulty responding, he or she may ask the operator for prompts.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group with social robot | Experimental | The emotional skills protocol aims to achieve the following objectives:
* Acquisition of appropriate emotional skills and understanding of emotions;
* Construction of functional thoughts related to emotions;
* Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. The experimental group will carry out training through the use of social robots. The robot provides instructions and if the child requests it, it gives prompts. Receives: Other: NAO intervention |
| Control group without social robot | Other | The emotional skills protocol aims to achieve the following objectives:
* Acquisition of appropriate emotional skills and understanding of emotions; Construction of functional thoughts related to emotions;
* Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. Control group which will be conducted through traditional therapy. The therapist provides instructions, and if the child has difficulty responding, he gives prompts. Receives: Other: Traditional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Emotional Vocabulary
The Test of Emotional Vocabulary contains an initial board, with which the child is introduced to the two protagonists of the subsequent stories, a boy and a girl; there is then a pretest board and 14 storyboards. For each of them, the examiner reads the short story to the child and then asks the child to choose, from two alternative emotional words, the one that best expresses what the protagonist of the story is feeling. In the first part, the child's understanding of emotional vocabulary referring to six basic emotions plus one complex emotion (joy, happiness, sadness, anger, fear, disgust and shame) is assessed; in the second part, the emotional terms all refer to complex emotions (guilt, envy, jealousy, contempt, hate, longing and pride).
Measured: The administration has a duration of 15 minutes.
Test of emotion comprehension
The Test of emotion comprehension (TEC) is an instrument to assess a child's understanding of emotions, in its various aspects, that is, the nature, causes, and ways of controlling and regulating emotions. It is used for children aged 3-4 to 10-11 years. It is administered by telling a story in pictures, the child responds by indicating and finally, it takes about 15-20 minutes.
Measured: The administration has a duration of 15-20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start5 Jun 2023
- Primary completion6 Feb 2024
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179953
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-010
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
Berkovits, L., Eisenhower, A. e Blacher, J. (2017). Regolazione delle emozioni nei bambini piccoli con disturbi dello spettro autistico. Giornale di autismo e disturbi dello sviluppo, 47(1), 68-79.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills
- ClinicalTrials.gov ID
- NCT06179953
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-010
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, children, emotional skills, social robot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 22 Dec 2023 (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 is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.
In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.
Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).
The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group with social robot | Experimental | Other: NAO interventionThe emotional skills protocol aims to achieve the following objectives: * Acquisition of appropriate emotional skills and understanding of emotions; * Construction of functional thoughts related to emotions; * Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. The experimental group will carry out training through the use of social robots. The robot provides instructions and if the child requests it, it gives prompts. |
| Control group without social robot | Other | Other: Traditional interventionThe emotional skills protocol aims to achieve the following objectives: * Acquisition of appropriate emotional skills and understanding of emotions; Construction of functional thoughts related to emotions; * Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. Control group which will be conducted through traditional therapy. The therapist provides instructions, and if the child has difficulty responding, he gives prompts. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Language in sentences
- use of connectors
- ability to narrate events not present
- ADOS level: module 2
- Griffiths: QS>75
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 |
|---|---|---|
| NAO interventionThe protocol is divided into 4 stages: 1. EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions. 2. EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented. 3. DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thought to an emotion. 4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The robot provides instructions and if the child requests it, it elects prompts. | Other | Experimental group with social robot |
| Traditional interventionThe protocol is divided into 4 stages: 1. EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions. 2. EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented. 3. DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thought to an emotion. 4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The therapist provides instructions, and if the child has difficulty responding, he or she may ask the operator for prompts. | Other | Control group without social robot |
Primary outcome
Test of Emotional Vocabulary
Time frame: The administration has a duration of 15 minutes.
The Test of Emotional Vocabulary contains an initial board, with which the child is introduced to the two protagonists of the subsequent stories, a boy and a girl; there is then a pretest board and 14 storyboards. For each of them, the examiner reads the short story to the child and then asks the child to choose, from two alternative emotional words, the one that best expresses what the protagonist of the story is feeling. In the first part, the child's understanding of emotional vocabulary referring to six basic emotions plus one complex emotion (joy, happiness, sadness, anger, fear, disgust and shame) is assessed; in the second part, the emotional terms all refer to complex emotions (guilt, envy, jealousy, contempt, hate, longing and pride).
Test of emotion comprehension
Time frame: The administration has a duration of 15-20 minutes.
The Test of emotion comprehension (TEC) is an instrument to assess a child's understanding of emotions, in its various aspects, that is, the nature, causes, and ways of controlling and regulating emotions. It is used for children aged 3-4 to 10-11 years. It is administered by telling a story in pictures, the child responds by indicating and finally, it takes about 15-20 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
- BackgroundBerkovits, L., Eisenhower, A. e Blacher, J. (2017). Regolazione delle emozioni nei bambini piccoli con disturbi dello spettro autistico. Giornale di autismo e disturbi dello sviluppo, 47(1), 68-79.
- 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.
Flavia Marino principal investigator
Istituto per la Ricerca e l'Innovazione Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAO intervention and Traditional intervention in people with 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 5 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: looking for participants now, as of the sponsor's last update on 17 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Germana Doria (+393465142289, germana.doria@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Emotional Vocabulary (time frame: The administration has a duration of 15 minutes.). 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 NCT06179953, which also lists 2 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 17 Jan 2025.