Clinical trial NCT06278155: Social Relations Training for Children With ASD
Official title: Enhancing Social Relations: Training Protocol for Children With ASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
children
social relations
social robot
NAO
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2024-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* language in sentences
* Griffiths: QS\>75

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)
timeFrame: The administration of the Vineland-II takes approximately 20-60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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).
citation: 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.