NCT07207213

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

Not yet recruiting NA Last updated 3 October 2025

What this trial tests

NA trial testing PEERS in Autism Spectrum Disorder in 36 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
30 January 2027

30 September 2027

Quick facts

Lead sponsor	IRCCS Fondazione Stella Maris
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	supportive care
Enrollment	36
Start date	1 January 2026
Primary completion	30 January 2027
Estimated completion	30 September 2027
Sites	1 location across Italy

Drugs / interventions tested

• PEERS
• Control

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

IRCCS Fondazione Stella Maris — full company profile →

Who can join

Adults 10 to 14, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.