NCT06854133Active, not recruiting
Factors of Effectiveness in Italian Forensic Treatment
Longitudinal Study Comparing an Italian and a Californian Population of Mentally Ill Offenders: Identification of Forensic Treatment Effectiveness Factors
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
Over recent years, in Italy, the treatment of mentally ill offenders has undergone profound changes following successive legislative interventions, culminating in Law no. 81/2014, which closed all high-security psychiatric hospitals (OPG) and established a community-based forensic care model managed exclusively by the National Health Service. This model, centred on REMS and territorial mental health services, is unique in the Western context and emphasises rehabilitation, recovery, and time-limited custodial measures. In California, forensic treatment is regulated by the California Penal Code and delivered mainly within high-security state hospitals coordinated by the Department of State Hospitals (DSH), with long average lengths of stay and strong standardisation of security procedures. The two systems therefore differ markedly in structure, duration of stay, and balance between security and rehabilitative goals, raising questions about their respective effectiveness in terms of clinical outcomes, functional recovery, and violent recidivism. This multicentre, prospective cohort study compares Italian forensic patients (Group I) and Californian forensic patients (Group C), enrolled at first entry into forensic care and followed longitudinally for three years with assessments at T0, T1, T2, and T3 using harmonised tools (BPRS 4.0, WHODAS 2.0, HCR-20 V3, SAPROF, DUNDRUM Toolkit, MOAS) and a common data collection form. Primary aims include a detailed epidemiological characterisation of the Italian forensic population and a systematic comparison of outcomes between the Italian and Californian models with respect to violent recidivism, length of stay in forensic settings, clinical and functional improvement, and recovery indicators. Comparative analyses focus on subgroups of participants with psychotic disorders and mental disorders directly related to the index offence, in order to examine differences in outcomes attributable to systemic and organisational features of the two forensic treatment models rather than to diagnostic or criminological heterogeneity.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- University of Bari
- NCT number
- NCT06854133
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Feb 2025 to the primary completion date, 31 Dec 2030
- 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
- MMSE score below 18 (severe cognitive impairment preventing administration of study instruments)
- Acute medical conditions preventing the administration of the evaluation instruments specified in the research protocol
Age
- Age under 18 years
Other
- Inability to provide written informed consent and absence of a legal guardian or Support Administrator available to provide substitute consent
Who the study is looking for
- Group I - Italy:
- All subjects subject to custodial security measures (e.g., REMS) or non-custodial security measures (e.g., supervised liberty, placement in dedicated forensic community residential facilities - CRAP), regardless of clinical diagnosis or type of offence committed
- Both definitive and provisional security measures are included
- Management contexts include residential, semi-residential, and community-based settings
- Age ≥ 18 years
- Group C - California:
- Patients admitted to secure hospitals or community forensic facilities for incompetency to stand trial (IST) or not guilty by reason of insanity (NGRI), pursuant to the California Penal Code
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 Medicina, 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.