Social Robotics Intervention for Improving Socio-Pragmatic Skills in Autism: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Wechsler Intelligence Scale for Children 4° edizione (WISC-IV)
研究概览
简要总结
Socio-pragmatics focuses on the study of language in the context of social interactions. It explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. Socio-pragmatics analyzes linguistic and nonlinguistic behaviors, such as gestures, facial expressions, tone of voice, and posture, to understand intended meaning, social implications, and shared communicative norms. Children with autism often present difficulties in social-pragmatic skills.
The integration of advanced technologies can play a crucial role in innovative approaches to the development of this skill.
In this experimental protocol, an attempt will be made to demonstrate the effectiveness of training through the use of social robots by comparing the performance of an ASD group performing a treatment using social robots with a control group performing the same in a traditional manner.
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
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 8 and 13 years
- •Clinical diagnosis of ASD according to DSM-5 criteria by a licensed child neuropsychiatrist
- •Verbal and performance IQ > 75 and total IQ > 85, assessed with the WISC-IV
- •No current aggressive behavior or severe oppositional tendencies
- •No hearing, vision, or physical impairments that could interfere with participation
- •Not currently taking any psychotropic medications
排除标准
- •Absence of a clinical diagnosis of ASD based on DSM-5 criteria
- •Verbal or performance IQ ≤ 75, or total IQ ≤ 85 as assessed by WISC-IV
- •Presence of aggressive behavior or severe oppositional tendencies
- •Hearing, vision, or physical impairments that could hinder participation in the intervention
- •Current use of psychotropic medications
结局指标
主要结局
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV)
时间窗: Baseline assessment at Day 1 (prior to intervention); the test requires approximately 56-80 minutes to complete.
Wechsler Intelligence Scale for Children 4° edizione (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
Language Pragmatic Abilities (APL) -MEDEA
时间窗: Baseline assessment at Day 1 (pre-intervention) and post-intervention assessment at 3 months (at the end of the intervention); each test session lasts approximately 30-45 minutes.
The APL MEDEA is a standardized assessment tool specifically designed to evaluate socio-pragmatic skills in individuals aged 5 to 14 years. This test measures various aspects of pragmatic language skills that are essential for effective communication within social contexts. The main objective of the APL MEDEA is to assess pragmatic language skills employed during everyday interactions, including the understanding and appropriate use of language in various social situations, recognition of social cues, and effective conversational strategies. The total score ranges from 0 to 68.
次要结局
未报告次要终点
研究者
Flavia Marino
Head of Unit
Istituto per la Ricerca e l'Innovazione Biomedica