Social Relations Training for Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Enhancing Social Relations: Training Protocol for Children With ASD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278155
• Other study ID #: CNR-IRIB-PRO-2024-001
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: April 28, 2025

Study information

• Verified date: February 2024
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Germana Doria
• Phone: +393465142289
• Email: germana.doria[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 28, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• language in sentences

• Griffiths: QS>75

Exclusion Criteria:

• presence of other medical disorders

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Social relation training with social robot
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
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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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).

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.