Social Relations Training for Children With ASD

NCT06278155 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2024-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

autism; children; social relations; social robot; NAO

Outcome Measures

Primary Outcomes (1)

• 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.

  The administration of the Vineland-II takes approximately 20-60 minutes.

Study Arms (2)

Experimental social relations group

EXPERIMENTAL

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

Control social relations group

OTHER

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

Interventions

Social relation training with social robot OTHER

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

Experimental social relations group

Traditional social relations training OTHER

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.

Control social relations group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• language in sentences
• Griffiths: QS\>75

You may not qualify if:

• presence of other medical disorders

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Messina, Italy: collaborator

Study Sites (1)

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

Messina, 98164, Italy

RECRUITING

Related Publications (3)

• Ntaountaki, Polyxeni & Lorentzou, Georgia & Lykothanasi, Andriana & Anagnostopoulou, Panagiota & Alexandropoulou, Vasiliki & Drigas, Athanasios. (2019). Robotics in Autism Intervention. 7. 4-17. 10.3991/ijes.v7i4.11448.

  BACKGROUND

• Chung, E.Yh. Robotic Intervention Program for Enhancement of Social Engagement among Children with Autism Spectrum Disorder. J Dev Phys Disabil 31, 419-434 (2019).

  BACKGROUND

• Rakhymbayeva N, Amirova A, Sandygulova A. A Long-Term Engagement with a Social Robot for Autism Therapy. Front Robot AI. 2021 Jun 16;8:669972. doi: 10.3389/frobt.2021.669972. eCollection 2021.

  PMID: 34222353 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Robotics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Flavia Marino

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Germana Doria

CONTACT

+393465142289; germana.doria@irib.cnr.it

Maria Valeria Maiorana

CONTACT

+393285856656; mariavaleria.maiorana@irib.cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: April 17, 2023
• Primary Completion: January 15, 2025
• Study Completion: April 28, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)