Italian Adaptation and Validation of the In-person UCLA-PEERS® Model for Adolescents With Autistic Spectrum Disorder

IRCCS Fondazione Stella Maris2 个研究点分布在 1 个国家目标入组 36 人开始时间: 2026年1月1日最近更新: 2025年10月3日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: IRCCS Fondazione Stella Maris
入组人数: 36
试验地点: 2
主要终点: Test of Adolescent Social Skills Knowledge-Revised (TASSK-R)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Autism Spectrum Disorder (ASD) falls under the category of high complexity disorders which, in most cases, accompany individuals throughout their entire life with significant impacts and costs for individuals, their families, and society at large. Adolescence is a time of increasing challenge for teenagers with ASD and their families, as it is a time to lay the foundations for the transition to adulthood but at the same time, it is a period of clear mismatch between the abilities and interests of teenagers with ASD and the expectations of their peers. It becomes increasingly difficult to initiate and maintain friendships that require social skills, communicate through social media, or make appropriate use of humor. It is in peer relationships that recognizing and applying implicit social norms is more difficult, and social errors can lead to a bad reputation, exclusion, and being bullied.

This creates the need for concrete responses through evidence-based treatment programs adapted to the Italian context. In this scenario, the Program for the Education and Enrichment of Relational Skills (PEERS®) fits in, a psychosocial intervention that falls under the category of Social Skill Training (SST) conducted in a group context, evidence-based, originating from the United States for adolescents with ASD that involves structured teaching of knowledge and skills related to social relationships.

SOCIAL has three main objectives: clinical, scientific, and social. The clinical objective is articulated in the study of the effectiveness of the in-person PEERS® program on an Italian population of adolescents with ASD (aged between 10 and 14) to respond to the evident need for a psychosocial intervention adapted to the Italian context. The scientific objective aims to identify an electroencephalographic biomarker that acts as a predictor of the efficacy of PEERS® and is specific to a particular individual profile. Finally, the social objective intends to extend the support network of adolescents with ASD through meetings with schools to train Teachers, thus parallelizing the treatment for generalization of the skills acquired during clinical treatment and also to the school context where peers play a key role.

SOCIAL aims to respond to a gap that exists in Italy for a critical age group involving teenagers with ASD, proposing an evidence-based treatment that extends to family and school contexts.

详细描述

Objectives SOCIAL has 3 objectives, clinical, scientific, and social in nature. At the clinical level, its objective is to test the validity and effectiveness of the in-person PEERS® program adapted to an Italian population. The main rationale is to respond to the need for a Social Skill Training adapted to the Italian context, highly acceptable, and evidence-based.

SOCIAL involves a sample of 36 adolescents with a diagnosis of autism spectrum disorder (ASD) and their parents. The subjects will be randomized into two groups (experimental group and control group). All subjects will undergo a battery of questionnaires prescribed by the PEERS® protocol administered before treatment (T0), at the end (T1), and at the 9-month follow-up from the beginning of treatment (T2). The subjects will also undergo a high-density electroencephalographic evaluation during the viewing of social content stimuli at T0, T1, and T2. The experimental group will participate in the PEERS® protocol, while the control group will undergo the usual treatment provided by the territorial reality. Test scores will be compared within-group over time (T0-T1-T2) and between groups (experimental group vs. control group).

The second scientific objective will use the electroencephalographic signal (mu rhythm desynchronization in sensorimotor regions) as a predictor of the effectiveness of PEERS®. This measure, not strictly associated with severity, becomes an implicit predictor not mediated by cognitive factors that suggest the potential effectiveness of specific treatment for a certain individual profile. As secondary outcomes, scores related to questionnaires investigating the adolescents behavior and adaptive level will also be considered.

The last social objective aims to extend the support network of adolescents with ASD to the school context through meetings that parallel the treatment in order to (1) provide supportive strategies to teachers in continuity with clinical treatment and (2) monitor the transfer of social skills in the classroom context for generalization of the skills acquired during clinical treatment.

The hypothesis is that social skills will improve following treatment for the experimental group and that the impact will also extend to other social conditions while maintaining appropriate behavior.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Supportive Care
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 10 Years 至 14 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•(a) age between 10 and 14 years;
•clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992);
•absence of intellectual disability (IQ over 85);
•absence of a concomitant major psychiatric disorder (e.g., schizophrenia, bipolar disorder, psychiatric illness);
•absence of oppositional/aggressive behavior (outside the family context);
•difficulty developing and/or maintaining peer relationships;
•self-motivation to participate in the treatment of both the adolescent and the family;
•availability of a caregiver to regularly attend sessions with parents and to support the participant during the program;
•consent of the parents and the adolescent to participate in all evaluations and to be recorded during treatment sessions

排除标准

•Full IQ below 85;
•concomitant major psychiatric disorders