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Clinical Trials/NCT06342583
NCT06342583
Recruiting
Not Applicable

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

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country30 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
30
Locations
1
Primary Endpoint
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
February 10, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Responsible Party
Principal Investigator
Principal Investigator

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

Eligibility Criteria

Inclusion Criteria

  • diagnosis of autism
  • intelligence quotient ≥ 80

Exclusion Criteria

  • presence of other medical disorders

Outcomes

Primary Outcomes

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

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.

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

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

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)

Study Sites (1)

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