AutismNCT06278155
Social Relations Training for Children With ASD
A study testing Social relation training with social robot and Traditional social relations training 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
The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Social relation training with social robot and Traditional social relations training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2023to 28 Apr 2025
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- language in sentences
- Griffiths: QS>75
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
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
Giovanni Pioggia, +393203390892, giovanni.pioggia@irib.cnr.it
About this study
Official title: Enhancing Social Relations: Training Protocol for Children With ASD
The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.
The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.
Read more
The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.
The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.
In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Social relation training with social robot, Traditional social relations training
- Keywords
- autism, children, social relations, social robot, NAO
- 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.
Social relation training with social robotOther
The protocol is divided in two sections: basic and advanced social relations.
The "basic social relations"section consists of 4 stages:
Stage 1 focuses on spontaneous eye contact between the child and the robot Strage 2 introduces the goal of spontaneously looking at a peer Stage 3 focuses on respecting the turn between children Stage 4 aims to encourage peer cooperation Nao social robot helps children to develop specific social skills.
The "advanced social relation" section consists of 5 stages:
Stage 1: The goal is to initiate physical interaction with a peer during a game Stage 2 is focused on mand (verbal requests) directed to peers Stage 3: The goal is to respond spontaneously to questions or statements from peers In the Stage 4 the child should to play with peers for at least 5 minutes Stage 5: the goal is to conduct at least 4 verbal exchanges on a given topic with peers At each stage, Nao provides verbal prompts to guide the child toward the appropriate response
Traditional social relations trainingOther
Traditional social relations training is the same as the experimental one, however in this context the entire protocol is conducted without the aid of social robot NAO.
| Study group | Role | What they receive |
|---|---|---|
| Experimental social relations group | Experimental | In the experimental group, a social robot is expected to mediate the relationship among peers. Its task is to prompt, reinforce and support the participants' responses. In this case, it is the therapist who mediates the relationship by prompting, reinforcing and supporting the participants' responses. Receives: Other: Social relation training with social robot |
| Control social relations group | Other | In the control group, the therapist is expected to act as a mediator of the relationship, prompting, reinforcing and supporting the participants' responses. Receives: Other: Traditional social relations training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)
The Vineland-II, a revision of the Vineland Adaptive Behavior Scales (Vineland ABS), assess adaptive behavior (AC), i.e., the activities that the individual habitually performs to meet the expectations of personal autonomy and social responsibility characteristic of people of the same age and cultural background.
Specifically, they aim to measure CA in the domains Communication, Skills of Daily Living, Socialization (in individuals from 0 to 90 years of age) and Motor Skills (in individuals from 0 to 7 years of age and 56 to 90 years of age). Assessment of CA is necessary for diagnosis of intellectual disability disorder and, in accordance with DSM-5, for assessment of the level of severity of the disorder.
The Vineland-IIs consist of 4 scales divided into 11 subscales. They also provide an overall CA index.
Measured: The administration of the Vineland-II takes approximately 20-60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start17 Apr 2023
- Primary completion15 Jan 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT06278155
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-001
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ntaountaki, Polyxeni & Lorentzou, Georgia & Lykothanasi, Andriana & Anagnostopoulou, Panagiota & Alexandropoulou, Vasiliki & Drigas, Athanasios. (2019). Robotics in Autism Intervention. 7. 4-17. 10.3991/ijes.v7i4.11448.
Chung, E.Yh. Robotic Intervention Program for Enhancement of Social Engagement among Children with Autism Spectrum Disorder. J Dev Phys Disabil 31, 419-434 (2019).
Rakhymbayeva N, Amirova A, Sandygulova A. A Long-Term Engagement with a Social Robot for Autism Therapy. Front Robot AI. 2021 Jun 16;8:669972. doi: 10.3389/frobt.2021.669972. eCollection 2021.
PubMed 34222353
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Social Relations: Training Protocol for Children With ASD
- ClinicalTrials.gov ID
- NCT06278155
- Acronym / sponsor ID
- CNR-IRIB-PRO-2024-001
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, children, social relations, social robot, NAO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 26 Feb 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.
The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.
The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.
The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.
The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.
In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental social relations group | Experimental | Other: Social relation training with social robotIn the experimental group, a social robot is expected to mediate the relationship among peers. Its task is to prompt, reinforce and support the participants' responses. In this case, it is the therapist who mediates the relationship by prompting, reinforcing and supporting the participants' responses. |
| Control social relations group | Other | Other: Traditional social relations trainingIn the control group, the therapist is expected to act as a mediator of the relationship, prompting, reinforcing and supporting the participants' responses. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- language in sentences
- 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 |
|---|---|---|
| Social relation training with social robotThe protocol is divided in two sections: basic and advanced social relations. The "basic social relations"section consists of 4 stages: Stage 1 focuses on spontaneous eye contact between the child and the robot Strage 2 introduces the goal of spontaneously looking at a peer Stage 3 focuses on respecting the turn between children Stage 4 aims to encourage peer cooperation Nao social robot helps children to develop specific social skills. The "advanced social relation" section consists of 5 stages: Stage 1: The goal is to initiate physical interaction with a peer during a game Stage 2 is focused on mand (verbal requests) directed to peers Stage 3: The goal is to respond spontaneously to questions or statements from peers In the Stage 4 the child should to play with peers for at least 5 minutes Stage 5: the goal is to conduct at least 4 verbal exchanges on a given topic with peers At each stage, Nao provides verbal prompts to guide the child toward the appropriate response | Other | Experimental social relations group |
| Traditional social relations trainingTraditional social relations training is the same as the experimental one, however in this context the entire protocol is conducted without the aid of social robot NAO. | Other | Control social relations group |
Primary outcome
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)
Time frame: The administration of the Vineland-II takes approximately 20-60 minutes.
The Vineland-II, a revision of the Vineland Adaptive Behavior Scales (Vineland ABS), assess adaptive behavior (AC), i.e., the activities that the individual habitually performs to meet the expectations of personal autonomy and social responsibility characteristic of people of the same age and cultural background. Specifically, they aim to measure CA in the domains Communication, Skills of Daily Living, Socialization (in individuals from 0 to 90 years of age) and Motor Skills (in individuals from 0 to 7 years of age and 56 to 90 years of age). Assessment of CA is necessary for diagnosis of intellectual disability disorder and, in accordance with DSM-5, for assessment of the level of severity of the disorder. The Vineland-IIs consist of 4 scales divided into 11 subscales. They also provide an overall CA index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- BackgroundNtaountaki, Polyxeni & Lorentzou, Georgia & Lykothanasi, Andriana & Anagnostopoulou, Panagiota & Alexandropoulou, Vasiliki & Drigas, Athanasios. (2019). Robotics in Autism Intervention. 7. 4-17. 10.3991/ijes.v7i4.11448.
- BackgroundChung, E.Yh. Robotic Intervention Program for Enhancement of Social Engagement among Children with Autism Spectrum Disorder. J Dev Phys Disabil 31, 419-434 (2019).
- Background: PubMed 34222353Rakhymbayeva N, Amirova A, Sandygulova A. A Long-Term Engagement with a Social Robot for Autism Therapy. Front Robot AI. 2021 Jun 16;8:669972. doi: 10.3389/frobt.2021.669972. eCollection 2021.
- 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
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 Social relation training with social robot and Traditional social relations training 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 2 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 26 Feb 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 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?
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) (time frame: The administration of the Vineland-II takes approximately 20-60 minutes.). 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 NCT06278155, 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 26 Feb 2024.