AutismNCT06342583
Advanced Social Relations Training
A study testing Advanced social relations training with technical device and Advanced social relations training without technical device 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
Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Advanced social relations training with technical device and Advanced social relations training without technical device
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 10 Feb 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of autism
- intelligence quotient ≥ 80
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
Maria Valeria Maiorana, +393285856656, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Advanced Social Relations Training for Children and Young People With Autism Spectrum Disorder
Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.
The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Advanced social relations training with technical device, Advanced social relations training without technical device
- Keywords
- autism, children, social relation, awareness on social media, communication, social stories
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced social relations training with technical deviceOther
15 participants from the experimental group will undergo a first part in which they will be guided through social stories to construct an appropriate conversation repertoire. In the first phase the participants will see 8 social stories with scenes from everyday life and after learning the correct mode of interaction and communication they will be asked to interact in the group by playing the roles previously seen in the social stories. These will be shown on a technological device. Participants will have the opportunity to choose the correct mode of interaction by selecting it directly on the technological device. Each selected alternative will refer to the next scenario in relation to the selected answers. In the second phase participants will be instructed on the correct use of social media. Slides will be shown to explain risks and correct use and the operator will show on the technological device (Smartphone) all the practical steps to be taken (e.g. privacy settings).
Advanced social relations training without technical deviceOther
15 participants from the control group will undergo a first part in which they will be guided through social stories to build an appropriate conversation repertoire. In the first phase, the participants will see eight social stories illustrating scenes from everyday life and, after learning the correct modes of interaction and communication, they will be invited to interact in the group by playing the roles previously seen in the social stories. These will be shown in traditional mode (flashcards). Participants will have the opportunity to choose the correct mode of interaction by touching the card showing the appropriate mode. Each selected alternative will refer to the next scenario in relation to the selected answers. In the second phase participants will be instructed on the correct use of social media (facebook, instagram, TikTok, Whatsapp, YouTube). The trainer will show images on paper related to risks and correct use of social media.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 15 children from the experimental group will see social stories on a technological device (PC, tablet) and then see slides on a technological device concerning the correct use of social media. Receives: Other: Advanced social relations training with technical device |
| Traditional group | Other | 15 children in the control group will see social stories in paper form (flashcards) and then be exposed to the explanation of risks and correct use of social media in a traditional way (flashcards). Receives: Other: Advanced social relations training without technical device |
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 (AB), 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 AB 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 AB is necessary for diagnosis of intellectual disability disorder and, in accordance with Diagnostic and Statistical Manual of Mental Disorders (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 AB index.
Measured: the administration of the Vineland-II takes approximately 20-60 minutes
Eye contact
Unit of measurement: Number of visual contacts observed during social interaction.
Rating scale: 0 to 10, where 0 indicates no eye contact and 10 indicates constant eye contact
Measured: the administration of the test takes approximately 10 minutes
Smile in relation to group members' expressions
Unit of measurement: Number of smiles observed in relation to group members' expressions.
Rating scale: 0 to 10, where 0 represents no smiles and 10 indicates constant smiling in response to others' expression Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings
Measured: the administration of the test takes approximately 10 minutes
Greeting
Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings
Measured: the administration of the test takes approximately 10 minutes
Asking a question
Unit of measurement: Number of questions asked during social interaction. Rating scale: 0 to 10, where 0 indicates no questions and 10 indicates a high number of questions
Measured: the administration of the test takes approximately 10 minutes
Proposing an idea or activity to be carried out
Unit of measurement: Number of ideas or activities proposed during social interaction.
Rating scale: 0 to 10, where 0 indicates no proposals and 10 indicates a high number of proposals
Measured: the administration of the test takes approximately 10 minutes
Answering a question
Unit of measurement: Percentage of questions answered during social interaction. Rating scale: From 0% (no response) to 100% (response to all questions)
Measured: the administration of the test takes approximately 10 minutes
Taking verbal initiative
Unit of measurement: Number of times verbal initiative is taken during social interaction.
Rating scale: 0 to 10, where 0 indicates no verbal initiative and 10 indicates high verbal initiative
Measured: the administration of the test takes approximately 10 minutes
Approval/sharing gestures
Unit of measurement: Number of approval or sharing gestures observed during social interaction.
Rating scale: 0 to 10, where 0 indicates no approval/sharing gestures and 10 indicates a high frequency of such gestures.
Measured: the administration of the test takes approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Mar 2024
- Primary completion17 Mar 2025 (estimated)
- Study completion10 Feb 2026 (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 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
- 30 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
- NCT06342583
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-004
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ALMUMEN, H., & ALMUHAREB, K. (n.d.). Intervento di storia sociale arricchita dalla tecnologia: coinvolgere i bambini con disturbi dello spettro autistico nella comunicazione sociale. International Journal of Early Childhood Special Education, 12(1), 96-119. https://doi.org/10.20489/intjecse.726397
Camilleri LJ, Maras K, Brosnan M. The impact of using digitally-mediated social stories on the perceived competence and attitudes of parents and practitioners supporting children with autism. PLoS One. 2022 Jan 18;17(1):e0262598. doi: 10.1371/journal.pone.0262598. eCollection 2022.
PubMed 35041714
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Social Relations Training for Children and Young People With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06342583
- Acronym / sponsor ID
- CNR-IRIB-PRO-2024-004
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, children, social relation, awareness on social media, communication, social stories
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 17 Mar 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 2 Apr 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.
Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.
The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Advanced social relations training with technical device15 children from the experimental group will see social stories on a technological device (PC, tablet) and then see slides on a technological device concerning the correct use of social media. |
| Traditional group | Other | Other: Advanced social relations training without technical device15 children in the control group will see social stories in paper form (flashcards) and then be exposed to the explanation of risks and correct use of social media in a traditional way (flashcards). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of autism
- intelligence quotient ≥ 80
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 |
|---|---|---|
| Advanced social relations training with technical device15 participants from the experimental group will undergo a first part in which they will be guided through social stories to construct an appropriate conversation repertoire. In the first phase the participants will see 8 social stories with scenes from everyday life and after learning the correct mode of interaction and communication they will be asked to interact in the group by playing the roles previously seen in the social stories. These will be shown on a technological device. Participants will have the opportunity to choose the correct mode of interaction by selecting it directly on the technological device. Each selected alternative will refer to the next scenario in relation to the selected answers. In the second phase participants will be instructed on the correct use of social media. Slides will be shown to explain risks and correct use and the operator will show on the technological device (Smartphone) all the practical steps to be taken (e.g. privacy settings). | Other | Experimental group |
| Advanced social relations training without technical device15 participants from the control group will undergo a first part in which they will be guided through social stories to build an appropriate conversation repertoire. In the first phase, the participants will see eight social stories illustrating scenes from everyday life and, after learning the correct modes of interaction and communication, they will be invited to interact in the group by playing the roles previously seen in the social stories. These will be shown in traditional mode (flashcards). Participants will have the opportunity to choose the correct mode of interaction by touching the card showing the appropriate mode. Each selected alternative will refer to the next scenario in relation to the selected answers. In the second phase participants will be instructed on the correct use of social media (facebook, instagram, TikTok, Whatsapp, YouTube). The trainer will show images on paper related to risks and correct use of social media. | Other | Traditional 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 (AB), 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 AB 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 AB is necessary for diagnosis of intellectual disability disorder and, in accordance with Diagnostic and Statistical Manual of Mental Disorders (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 AB index.
Eye contact
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of visual contacts observed during social interaction. Rating scale: 0 to 10, where 0 indicates no eye contact and 10 indicates constant eye contact
Smile in relation to group members' expressions
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of smiles observed in relation to group members' expressions. Rating scale: 0 to 10, where 0 represents no smiles and 10 indicates constant smiling in response to others' expression Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings
Greeting
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings
Asking a question
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of questions asked during social interaction. Rating scale: 0 to 10, where 0 indicates no questions and 10 indicates a high number of questions
Proposing an idea or activity to be carried out
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of ideas or activities proposed during social interaction. Rating scale: 0 to 10, where 0 indicates no proposals and 10 indicates a high number of proposals
Answering a question
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Percentage of questions answered during social interaction. Rating scale: From 0% (no response) to 100% (response to all questions)
Taking verbal initiative
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of times verbal initiative is taken during social interaction. Rating scale: 0 to 10, where 0 indicates no verbal initiative and 10 indicates high verbal initiative
Approval/sharing gestures
Time frame: the administration of the test takes approximately 10 minutes
Unit of measurement: Number of approval or sharing gestures observed during social interaction. Rating scale: 0 to 10, where 0 indicates no approval/sharing gestures and 10 indicates a high frequency of such gestures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- BackgroundALMUMEN, H., & ALMUHAREB, K. (n.d.). Intervento di storia sociale arricchita dalla tecnologia: coinvolgere i bambini con disturbi dello spettro autistico nella comunicazione sociale. International Journal of Early Childhood Special Education, 12(1), 96-119. https://doi.org/10.20489/intjecse.726397
- Background: PubMed 35041714Camilleri LJ, Maras K, Brosnan M. The impact of using digitally-mediated social stories on the perceived competence and attitudes of parents and practitioners supporting children with autism. PLoS One. 2022 Jan 18;17(1):e0262598. doi: 10.1371/journal.pone.0262598. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Autism
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, 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.
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 Advanced social relations training with technical device and Advanced social relations training without technical device 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 2 Apr 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 (3465142289, 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). The study lists 9 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 NCT06342583, 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 2 Apr 2024.