NCT07374081Active, not recruiting
Italian Validation of the Forensic Autism Risk Assessment Scale (FARAS-IT)
Autism Spectrum Disorder and Criminal Responsibility in the Italian Forensic Context - Multicenter Study for Italian Validation of the Forensic Autism Risk Assessment Scale.
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 1 Dec 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Bari
- Diseases
- Autism
- NCT number
- NCT07374081
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Dec 2025 to the primary completion date, Feb 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.
Other illness
- acute medical conditions or clinical instability preventing participation in the evaluation;
Other
- 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.
Who the study is looking for
- 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.
- \-
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dipartimento Interdisciplinare Di Psichiatria Forense E Criminologia Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.