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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1
IRCCS Stella Maris
Calambrone, Pisa, Italy, 56018