跳至主要内容
临床试验/NCT06278155
NCT06278155Unknown不适用

Enhancing Social Relations: Training Protocol for Children With ASD

Istituto per la Ricerca e l'Innovazione Biomedica2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • language in sentences
  • Griffiths: QS>75

排除标准

  • presence of other medical disorders

研究组 & 干预措施

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.

干预措施: Traditional social relations training (Other)

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.

干预措施: Social relation training with social robot (Other)

结局指标

主要结局

Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istituto per la Ricerca e l'Innovazione Biomedica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

研究点 (2)

Loading locations...

相似试验