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NCT07207213Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
9 Oct 2024
Start date
1 Jan 2026
Primary completion date
30 Jan 2027
Lead sponsor
IRCCS Fondazione Stella Maris
Diseases
Autism
NCT number
NCT07207213

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 1 Jan 2026 to the primary completion date, 30 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • concomitant major psychiatric disorders

Other

  • Full IQ below 85;

Who the study is looking for

  • (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

Age in the registry: 10 years to 14 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Stella Maris
Coordinator of this site? Confirm its status
CalambroneItalyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.