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Active, not recruiting Observational

Italian Validation of the Forensic Autism Risk Assessment Scale (FARAS-IT)

NCT07374081 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-12-01
Last updated
2026-06-04

Condition(s) studied

Autism Spectrum Disorder (ASD

Study summary

The study is a multicenter observational project designed to translate, culturally adapt, and validate the Italian version of the FARAS (FARAS-IT), a structured framework for assessing risk and protective factors specific to individuals with Autism Spectrum Disorder (ASD) involved in the Italian criminal justice system.

Adult participants (≥18 years) with a diagnosis or well-founded clinical suspicion of ASD are consecutively enrolled over 12 months into three groups: offenders in forensic psychiatric settings under security measures, offenders considered criminally responsible and not under psychiatric care, and psychiatric patients with ASD without any history of criminal behavior followed by community mental health services or non-forensic residential facilities.

All participants undergo assessment with FARAS-IT and complementary clinical and forensic instruments (e.g., WHODAS 2.0, BPRS or equivalents, HCR-20, SAPROF, DUNDRUM), alongside collection of clinical, functional, and judicial variables, in order to evaluate the psychometric properties of FARAS-IT (factor structure, internal consistency, test-retest and inter-rater reliability, convergent and discriminant validity) and its clinical-forensic usefulness in understanding criminal responsibility and judicial decision-making trajectories in individuals with ASD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: Subjects will be included in the study who meet all of the following criteria: * age 18 years or older; * diagnosis of Autism Spectrum Disorder formally made according to DSM-5-TR criteria or well-founded clinical suspicion of ASD, documented by specialist evaluation; * insertion in one of the contexts provided for groups A, B, or C; * capacity to provide valid informed consent, clinically assessed, or presence of guardian/administrator of substance in cases provided by current law; * sufficient language and cognitive competence to participate in the evaluation, including with autism-informed communicative adaptations. The inclusion criterion based on \*well-founded clinical suspicion\* is consistent with the study's objective of intercepting the phenomenon of ASD under-diagnosis in adulthood, particularly in forensic and correctional contexts. \- Exclusion Criteria: Subjects presenting one or more of the following conditions will be excluded from the study: * acute medical conditions or clinical instability preventing participation in the evaluation; * acute psychotic state, severe disorganization of thought, or substance intoxication not stabilized at the time of assessment (with possibility of subsequent re-evaluation); * severe intellectual disability or cognitive compromise making any structured data collection impossible, even with adaptive supports; * refusal of informed consent. Exclusion will not be based on the type of offense, in order to avoid selective bias in the sample composition.

Primary outcome measure(s)

  • FARAS-IT total score — Baseline (T0), at enrollment
    Total score on the Italian version of the Forensic Autism Risk Assessment Scale (FARAS-IT), calculated as the sum of item ratings across seven domains (social communication, cognitive rigidity, cognitive empathy, adaptability, sensory sensitivity, emotional regulation, risk awareness). Higher total scores indicate greater autism-related vulnerability in the forensic context.

Trial sites (1)

FacilityCityRegionStatus
Dipartimento Interdisciplinare Di Psichiatria Forense E Criminologia Bari BA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374081 on ClinicalTrials.gov ↗ ← All trials in Italy