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Clinical Trials/NCT06278155
NCT06278155
Recruiting
N/A

Enhancing Social Relations: Training Protocol for Children With ASD

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country60 target enrollmentApril 17, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
60
Locations
1
Primary Endpoint
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
April 28, 2025
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

  • language in sentences
  • Griffiths: QS\>75

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 (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.

Study Sites (1)

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