Autism Spectrum Disorder (ASDASD_FARASITNCT07374081
Italian Validation of the Forensic Autism Risk Assessment Scale (FARAS-IT)
An observational study of Autism Spectrum Disorder (ASD, run by University of Bari at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to Feb 2029
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Apulia, Campania and Tuscany
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.
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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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento Interdisciplinare Di Psichiatria Forense E Criminologia
Bari, BA, 70121
About this study
Official title: Autism Spectrum Disorder and Criminal Responsibility in the Italian Forensic Context - Multicenter Study for Italian Validation of the Forensic Autism Risk Assessment Scale.
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.
Read the detailed description
The study is a multicenter, observational project aimed at translating, culturally adapting, and validating the Forensic Autism Risk Assessment Scale (FARAS-IT) for use in the Italian criminal responsibility context. It focuses on adults with Autism Spectrum Disorder (ASD) or well-founded clinical suspicion of ASD who are involved in different forensic and clinical settings, with the overarching goal of improving the structured assessment of vulnerability, risk, and protective factors relevant to criminal responsibility and judicial decision-making.
The research is designed as a non-randomized, cross-sectional, comparative cohort study with prospective enrollment of all eligible participants over a 12-month observation period (T0), with standardized data collection at the time of clinical-forensic or clinical evaluation. Participants are recruited in three Italian regions (Campania, Apulia, and Tuscany) from a range of contexts that reflect different degrees of involvement with the criminal justice and mental health systems, ensuring a heterogeneous and representative sample.
Three groups are included: Group A consists of perpetrators of criminal offenses managed in forensic psychiatric pathways and subject to detentive or non-detentive security measures (e.g., REMS, forensic residential and intermediate facilities, probation with therapeutic prescriptions); Group B includes perpetrators of offenses who are considered criminally responsible and are managed in correctional facilities or external criminal execution settings without a psychiatric treatment pathway; Group C comprises psychiatric patients with ASD who have never committed criminally relevant acts and are followed in community mental health services or non-forensic residential or semi-residential facilities. This tripartite structure allows the study to distinguish between factors associated with ASD per se and those specifically related to criminal behavior and forensic management.
The primary objective is to assess the psychometric properties of FARAS-IT, including internal consistency, reliability, convergent and discriminant validity, and its clinical-forensic utility across these settings. Secondary objectives include: clinically and forensically characterizing adults with ASD in different judicial and health contexts; exploring the associations between FARAS profiles, indicators of criminal responsibility, expert findings, and judicial outcomes; identifying under-diagnosed ASD among perpetrators not in psychiatric care; and evaluating the incremental contribution of FARAS-IT beyond traditional risk and functioning instruments such as HCR-20, SAPROF, DUNDRUM, and WHODAS 2.0.
FARAS-IT is administered to subjects with a diagnosis or well-founded suspicion of ASD and covers seven domains of autistic functioning that are particularly relevant for forensic formulations (e.g., social communication, cognitive rigidity, cognitive empathy, adaptability, sensory sensitivity, emotional regulation, and risk awareness). Data are gathered through clinical interviews, behavioral observation, and analysis of clinical and, where available, forensic documentation, and are integrated-when applicable-into existing forensic information systems such as the SMOP registry for patients in forensic psychiatric circuits.
All participants provide written informed consent, with specific attention to the vulnerability of forensic and correctional populations and to the communicative and cognitive characteristics associated with ASD. Consent procedures and information delivery are adapted using clear, concrete language, sufficient time for explanation, and, when needed, simplified communication supports; in cases of reduced decision-making capacity, legal guardians or administrators are involved in accordance with Italian law, while always seeking the participant's assent.
Data are pseudonymized and managed in line with EU Regulation 2016/679 (GDPR) and national legislation, with identifying information stored separately from clinical and psychometric datasets and accessible only to authorized personnel. Statistical analyses follow current psychometric and forensic psychiatry standards (e.g., COSMIN recommendations) and include descriptive analyses, exploratory and confirmatory factor analyses, reliability estimates, and comparative models to test the discriminatory capacity of FARAS-IT among the three groups and its relationship with judicial and clinical outcomes.
Ultimately, the study aims to provide the first systematic Italian validation of FARAS in a large, clinically and forensically diverse ASD population, contributing to more structured, transparent, and reproducible evaluations of criminal responsibility and procedural competence in individuals on the autism spectrum.
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- ASD,, FARAS,, Italian Criminal Justice,, Forensic Psychiatry, SPJ
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Dec 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felice Carabellese, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374081
- Sponsor's protocol ID
- ASD FARAS-IT
- Acronym
- ASD_FARASIT
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carabellese, F., & Felthous, A. R. (2016). Forensic psychiatric evaluation and criminal responsibility. *International Journal of Law and Psychiatry*, 49, 83-90.
Romano, M. (2018). *Imputabilità e responsabilità penale*. Milano: Giuffrè.
Fiandaca, G., & Musco, E. (2020). *Diritto penale. Parte generale*. Bologna: Zanichelli.
Mantovani, F. (2019). *Diritto penale. Parte generale*. Padova: CEDAM.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Spectrum Disorder and Criminal Responsibility in the Italian Forensic Context - Multicenter Study for Italian Validation of the Forensic Autism Risk Assessment Scale.
- ClinicalTrials.gov ID
- NCT07374081
- Acronym / sponsor ID
- ASD_FARASIT / ASD FARAS-IT
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- ASD,, FARAS,, Italian Criminal Justice,, Forensic Psychiatry, SPJ
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a multicenter, observational project aimed at translating, culturally adapting, and validating the Forensic Autism Risk Assessment Scale (FARAS-IT) for use in the Italian criminal responsibility context. It focuses on adults with Autism Spectrum Disorder (ASD) or well-founded clinical suspicion of ASD who are involved in different forensic and clinical settings, with the overarching goal of improving the structured assessment of vulnerability, risk, and protective factors relevant to criminal responsibility and judicial decision-making.
The research is designed as a non-randomized, cross-sectional, comparative cohort study with prospective enrollment of all eligible participants over a 12-month observation period (T0), with standardized data collection at the time of clinical-forensic or clinical evaluation. Participants are recruited in three Italian regions (Campania, Apulia, and Tuscany) from a range of contexts that reflect different degrees of involvement with the criminal justice and mental health systems, ensuring a heterogeneous and representative sample.
Three groups are included: Group A consists of perpetrators of criminal offenses managed in forensic psychiatric pathways and subject to detentive or non-detentive security measures (e.g., REMS, forensic residential and intermediate facilities, probation with therapeutic prescriptions); Group B includes perpetrators of offenses who are considered criminally responsible and are managed in correctional facilities or external criminal execution settings without a psychiatric treatment pathway; Group C comprises psychiatric patients with ASD who have never committed criminally relevant acts and are followed in community mental health services or non-forensic residential or semi-residential facilities. This tripartite structure allows the study to distinguish between factors associated with ASD per se and those specifically related to criminal behavior and forensic management.
The primary objective is to assess the psychometric properties of FARAS-IT, including internal consistency, reliability, convergent and discriminant validity, and its clinical-forensic utility across these settings. Secondary objectives include: clinically and forensically characterizing adults with ASD in different judicial and health contexts; exploring the associations between FARAS profiles, indicators of criminal responsibility, expert findings, and judicial outcomes; identifying under-diagnosed ASD among perpetrators not in psychiatric care; and evaluating the incremental contribution of FARAS-IT beyond traditional risk and functioning instruments such as HCR-20, SAPROF, DUNDRUM, and WHODAS 2.0.
FARAS-IT is administered to subjects with a diagnosis or well-founded suspicion of ASD and covers seven domains of autistic functioning that are particularly relevant for forensic formulations (e.g., social communication, cognitive rigidity, cognitive empathy, adaptability, sensory sensitivity, emotional regulation, and risk awareness). Data are gathered through clinical interviews, behavioral observation, and analysis of clinical and, where available, forensic documentation, and are integrated-when applicable-into existing forensic information systems such as the SMOP registry for patients in forensic psychiatric circuits.
All participants provide written informed consent, with specific attention to the vulnerability of forensic and correctional populations and to the communicative and cognitive characteristics associated with ASD. Consent procedures and information delivery are adapted using clear, concrete language, sufficient time for explanation, and, when needed, simplified communication supports; in cases of reduced decision-making capacity, legal guardians or administrators are involved in accordance with Italian law, while always seeking the participant's assent.
Data are pseudonymized and managed in line with EU Regulation 2016/679 (GDPR) and national legislation, with identifying information stored separately from clinical and psychometric datasets and accessible only to authorized personnel. Statistical analyses follow current psychometric and forensic psychiatry standards (e.g., COSMIN recommendations) and include descriptive analyses, exploratory and confirmatory factor analyses, reliability estimates, and comparative models to test the discriminatory capacity of FARAS-IT among the three groups and its relationship with judicial and clinical outcomes.
Ultimately, the study aims to provide the first systematic Italian validation of FARAS in a large, clinically and forensically diverse ASD population, contributing to more structured, transparent, and reproducible evaluations of criminal responsibility and procedural competence in individuals on the autism spectrum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Apulia, Campania and Tuscany
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FARAS-IT total score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- BackgroundCarabellese, F., & Felthous, A. R. (2016). Forensic psychiatric evaluation and criminal responsibility. *International Journal of Law and Psychiatry*, 49, 83-90.
- BackgroundRomano, M. (2018). *Imputabilità e responsabilità penale*. Milano: Giuffrè.
- BackgroundFiandaca, G., & Musco, E. (2020). *Diritto penale. Parte generale*. Bologna: Zanichelli.
- BackgroundMantovani, F. (2019). *Diritto penale. Parte generale*. Padova: CEDAM.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FARAS-IT total score (time frame: Baseline (T0), at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374081, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.