An interventional study of Social relation training with social robot and Traditional social relations training in Autism and Autism Spectrum Disorder, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Not applicable, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 46 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
In the experimental group, a social robot is expected to mediate the relationship among peers. Its task is to prompt, reinforce and support the participants' responses. In this case, it is the therapist who mediates the relationship by prompting, reinforcing and supporting the participants' responses.
Other: Social relation training with social robot
In the control group, the therapist is expected to act as a mediator of the relationship, prompting, reinforcing and supporting the participants' responses.
Other: Traditional social relations training
The protocol is divided in two sections: basic and advanced social relations. The "basic social relations"section consists of 4 stages: Stage 1 focuses on spontaneous eye contact between the child and the robot Strage 2 introduces the goal of spontaneously looking at a peer Stage 3 focuses on respecting the turn between children Stage 4 aims to encourage peer cooperation Nao social robot helps children to develop specific social skills. The "advanced social relation" section consists of 5 stages: Stage 1: The goal is to initiate physical interaction with a peer during a game Stage 2 is focused on mand (verbal requests) directed to peers Stage 3: The goal is to respond spontaneously to questions or statements from peers In the Stage 4 the child should to play with peers for at least 5 minutes Stage 5: the goal is to conduct at least 4 verbal exchanges on a given topic with peers At each stage, Nao provides verbal prompts to guide the child toward the appropriate response
Traditional social relations training is the same as the experimental one, however in this context the entire protocol is conducted without the aid of social robot NAO.
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 (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.
Time frame: The administration of the Vineland-II takes approximately 20-60 minutes.
Plan to share: No
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Istituto per la Ricerca e l'Innovazione Biomedica