protocolSection identificationModule nctId: NCT06278155, orgStudyIdInfo id: CNR-IRIB-PRO-2024-001, briefTitle: Social Relations Training for Children With ASD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-04-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, collaborators name: Messina, Italy, descriptionModule briefSummary: 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., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Social relation training with social robot, interventions name: Traditional social relations training, outcomesModule primaryOutcomes measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: flavia.marino@irib.cnr.it, contacts name: Giovanni Pioggia, role: CONTACT, phone: +393203390892, email: giovanni.pioggia@irib.cnr.it, contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Alfio Puglisi, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False