Advanced Social Relations Training

Autism Spectrum Disorder Clinical Trial

Official title:

Advanced Social Relations Training for Children and Young People With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342583
• Other study ID #: CNR-IRIB-PRO-2024-004
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: February 10, 2026

Study information

• Verified date: March 2024
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Germana Doria
• Phone: 3465142289
• Email: germana.doria[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 10, 2026
• Est. primary completion date: March 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• diagnosis of autism

• intelligence quotient = 80

Exclusion Criteria:

• presence of other medical disorders

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Advanced social relations training with technical device
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 device
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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Messina, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Erratum In: PLoS One. 2022 Jun 29;17(6):e0270948. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the administration of the Vineland-II takes approximately 20-60 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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)	the administration of the test takes approximately 10 minutes
Primary	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	the administration of the test takes approximately 10 minutes
Primary	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.	the administration of the test takes approximately 10 minutes