Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

IRCCS Fondazione Stella Maris

Conditions:

Autism Spectrum Disorder

Eligibility:

All Genders

10-14 years

Phase:

NA

Brief 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 ind...

Detailed Description

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 t...

Eligibility Criteria

Inclusion

  • (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

Exclusion

  • Full IQ below 85;
  • concomitant major psychiatric disorders

Key Trial Info

Start Date :

January 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2027

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT07207213

Start Date

January 1 2026

End Date

September 30 2027

Last Update

October 3 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

IRCCS Stella Maris

Calambrone, Pisa, Italy, 56018