Recruiting

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

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What is being tested

Advanced social relations training with technical device

+ Advanced social relations training without technical device

Other
Who is being recruted

Autism Spectrum Disorder+4

+ Autistic Disorder

+ Behavior

From 9 to 12 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorIstituto per la Ricerca e l'Innovazione Biomedica
Study ContactGermana DoriaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2024

Actual date on which the first participant was enrolled.

The study aims to help children and young people aged 9 to 12 with Autism Spectrum Disorder improve their social interactions. This group of participants is chosen because they have an average or above-average intelligence as indicated by an IQ of 80 or higher. The study uses both technology-based and traditional methods to teach social skills. The importance of this study lies in its potential to enhance the participants' ability to communicate effectively and navigate social situations, which can significantly improve their quality of life and help them connect better with others. Participants in the study attend weekly sessions lasting 45 minutes each, over a total of 23 sessions. In the initial sessions, they learn essential communication skills. As the sessions progress, they engage with social stories that depict everyday situations and practice these scenarios through role-playing. In the final part of the study, the sessions focus on teaching safe and effective use of social media, highlighting the potential risks and best practices for online interactions. This structured approach aims to equip participants with practical tools for real-life social interactions and responsible digital communication.

Official TitleAdvanced Social Relations Training for Children and Young People With Autism Spectrum Disorder
NCT06342583
Principal SponsorIstituto per la Ricerca e l'Innovazione Biomedica
Study ContactGermana DoriaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 9 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderAutistic DisorderBehaviorMental DisordersChild Development Disorders, PervasiveCommunicationNeurodevelopmental Disorders

Criteria

2 inclusion criteria required to participate
diagnosis of autism

intelligence quotient ≥ 80

1 exclusion criteria prevent from participating
presence of other medical disorders

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, ItalyOpen Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) in Google Maps
Recruiting
One Study Center