Social Relations Training for Children With ASD

February 19, 2024 updated by: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Enhancing Social Relations: Training Protocol for Children With ASD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98164
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Flavia Marino
        • Sub-Investigator:
          • Giovanni Pioggia
        • Sub-Investigator:
          • Paola Chilà
        • Sub-Investigator:
          • Roberta Minutoli
        • Sub-Investigator:
          • Noemi Vetrano
        • Sub-Investigator:
          • Chiara Failla
        • Sub-Investigator:
          • Germana Doria
        • Sub-Investigator:
          • Ileana Scarcella
        • Sub-Investigator:
          • Alfio Puglisi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • language in sentences
  • Griffiths: QS>75

Exclusion Criteria:

  • presence of other medical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental social relations group
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

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
Other: Control social relations group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The administration of the Vineland-II takes approximately 20-60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

Comune di Messina

Investigators

  • Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

April 28, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IRIB-PRO-2024-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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