SOCIAL: Adaptation and Validation of the In-person PEERS® Program for Adolescents With Autism.

NCT07207213 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Autism Spectrum Disorder

Interventions

BEHAVIORAL

PEERS

The Program for the Education and Enrichment of Relational Skills (PEERS®) is world-renowned for providing evidence-based social skills treatment to adolescents with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), anxiety, depression, and other socio-emotional problems.

BEHAVIORAL

Control

This group will also consist of children diagnosed with high-functioning ASD. However, these children will not receive PEERS therapy. Instead, they will continue their usual treatments in their local settings without participating in the PEERS therapy sessions. This group\'s outcomes will be compared with the experimental group to assess the effectiveness of PEERS therapy.

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    lead OTHER

Principal Investigators

  • Antonio Narzisi, PhD · IRCCS Stella Maris Foundation, Pisa (Calambrone), Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-30
Completion
2027-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207213 on ClinicalTrials.gov