NCT07374081

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
34mo left

Started Feb 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

January 5, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 5, 2026

Last Update Submit

January 20, 2026

Conditions

Keywords

ASD,FARAS,Italian Criminal Justice,Forensic PsychiatrySPJ

Outcome Measures

Primary Outcomes (1)

  • FARAS-IT total score

    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.

    Baseline (T0), at enrollment

Study Arms (3)

Perpetrators in Forensic Psychiatric context

Group A comprises all perpetrators of criminal offenses who, during the observation period, are subject to psychiatric security measures, both detentive (for example, REMS) and non-detentive (such as probation with therapeutic prescriptions)

Perpetrators considered criminally responsible

Group B includes subjects who are perpetrators of criminal offenses that do not result in being managed as psychiatric patients

Psychiatric patients' non-perpetrators of offenses

Group C comprises psychiatric patients who have never committed offenses, followed by territorial mental health services

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apulia, Campania and Tuscany

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Carabellese, F., & Felthous, A. R. (2016). Forensic psychiatric evaluation and criminal responsibility. *International Journal of Law and Psychiatry*, 49, 83-90.

    BACKGROUND
  • Romano, M. (2018). *Imputabilità e responsabilità penale*. Milano: Giuffrè.

    BACKGROUND
  • Fiandaca, G., & Musco, E. (2020). *Diritto penale. Parte generale*. Bologna: Zanichelli.

    BACKGROUND
  • Mantovani, F. (2019). *Diritto penale. Parte generale*. Padova: CEDAM.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Felice F Carabellese, Full Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FULL PROFESSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

January 28, 2026

Record last verified: 2026-01