Forging New Paths for Mental Illness

(FNP Trial)

Overseen By Jonathan Phillips, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Intellectual disability, Incarceration, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Forging New Paths, designed to assist people with mental illness who have interacted with the criminal justice system. The study aims to determine if this approach can reduce aggression and help participants remain in their communities longer. It also seeks to assess changes in impulsive behaviors and criminal attitudes. Participants will receive either Forging New Paths alongside their usual mental health care or just their usual care. Individuals with schizophrenia, major depression, or bipolar disorder who have been involved with the criminal justice system might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mental health care for individuals with similar experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Forging New Paths is safe for people with mental illness?

Research shows that "Forging New Paths" is a new program designed for individuals with serious mental health issues who might interact with the criminal justice system. Studies have examined its effectiveness in reducing aggression and supporting longer community stays.

Detailed safety information is not yet available, but the program includes group sessions and regular community mental health services, similar to other generally well-tolerated mental health treatments. As the trial is in an early stage, researchers are still gathering evidence on its safety for participants. Early-phase trials are typically conducted with caution and closely monitored for any potential issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Forging New Paths" treatment because it offers a unique approach to managing mental illness. Unlike standard care options, which typically involve medication and therapy, this treatment combines innovative techniques with usual community-based mental health services. This dual approach might enhance the effectiveness of traditional care by providing additional support and resources tailored to an individual's needs. By integrating new strategies with existing methods, "Forging New Paths" has the potential to improve outcomes for individuals with mental health conditions, making it an exciting development in the field.

What evidence suggests that Forging New Paths might be an effective treatment for mental illness?

Research has shown that Forging New Paths (FNP) is designed to help people with serious mental illness (SMI) who have interacted with the criminal justice system. This trial will compare two groups: one receiving the FNP program in addition to usual care, and a control group receiving usual care alone. The FNP program aims to reduce aggressive behavior and help participants avoid trouble while living in the community. Early results suggest that FNP addresses important issues like impulsive actions and criminal thinking, which are linked to aggression. By focusing on these areas, FNP aims to help participants make positive life changes. While detailed results on FNP’s success are still being collected, its approach appears promising in meeting the unique needs of this group. ^{1 2 3 6 7}

Who Is on the Research Team?

Amy Wilson, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals with mental health disorders who have had contact with the criminal legal system. They must pass a screening interview to participate. The study will involve those willing to be randomly assigned to either the new intervention, Forging New Paths plus usual care, or to receive usual care alone.

Inclusion Criteria

History of any type of criminal justice system involvement (i.e., arrest, conviction, incarceration, or probation/parole)

Reside in the community and receive services from the Center for Excellence in Community Mental Health or one of their partner agencies

Have moderate or higher levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)

Exclusion Criteria

Intellectual or developmental disability

Incarceration at the point of study enrollment

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the Forging New Paths intervention in addition to usual care or usual care alone

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 9 months

3 months

1 visit (in-person) at 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Forging New Paths

Trial Overview The clinical trial is testing 'Forging New Paths,' an intervention aimed at reducing aggression and increasing community tenure among people with mental illness. It compares this approach against standard care practices by assessing changes in impulsivity and criminal attitudes.

How Is the Trial Designed?

Group I: Experimental: Forging New Paths + Usual Care Experimental Treatment 1 Intervention

The experimental condition receives Forging New Paths in addition to community based mental health services as determined by their treatment providers.

Group II: Control: Usual Care Alone Active Control 1 Intervention

The control condition receives community based mental health services as determined by their treatment providers.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The 'number needed to harm' (NNH) metric has significant limitations in assessing the risks of adverse drug events (ADEs) from psychotropic medications, including arbitrary cutoffs and limited adjustments for confounding factors.

Postmarketing surveillance using case-control studies offers more reliable data on serious ADEs compared to the NNH, highlighting the need for better risk assessment methods in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Number needed to harm: its limitations in psychotropic drug safety research. Safer, DJ., Zito, JM.[2013]

The implementation of an integrated care pathway (ICP) for 224 patients with schizophrenia aimed to improve collaboration between hospital and community mental health services, but showed minimal effectiveness in reducing re-hospitalization rates or inpatient costs.

Despite efforts to enhance compliance with established procedures during hospitalization, significant disagreements between sectors persisted, indicating that the ICP did not achieve its intended goals and led to the phasing out of ineffective initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Alliance Programme: an integrated care pathway for patients with schizophrenia]. Nielsen, B., Sigsgaard, A., Gregersen, J., et al.[2019]

A consensus among schizophrenia researchers identified four key outcome domains for measuring clinical effectiveness: symptoms of disease, treatment burden, disease burden, and health and wellness.

The Global Outcome Assessment of Life in Schizophrenia (GOALS) was developed as a clinical tool to objectively measure these domains, aiming to enhance treatment expectations beyond just symptom control to include functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and measuring clinical effectiveness in the treatment of schizophrenia. Nasrallah, HA., Targum, SD., Tandon, R., et al.[2022]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

In a study of 227 patient admissions across three mental health trusts, the rate of confirmed adverse drug events (ADEs) was found to be 12.6 per 100 admissions, with nearly 20% of these events deemed preventable, highlighting a significant safety concern in mental health settings.

The majority of ADEs were linked to medications affecting the central nervous system, particularly antipsychotics and antidepressants, and longer hospital stays increased the risk of experiencing an ADE, indicating a need for targeted interventions to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, Nature, Severity and Preventability of Adverse Drug Events in Mental Health Settings: Findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) Study. Alshehri, GH., Ashcroft, DM., Nguyen, J., et al.[2022]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The implementation of a clinical care pathway for 114 patients with schizophrenia led to more frequent diagnostic tests and a significant reduction in the number of patients who were over- or undermedicated, indicating improved adherence to treatment guidelines.

Despite these process improvements, the patients' reported outcomes and assessments of their condition worsened after the pathway was implemented, suggesting that the pathway did not translate into better treatment efficacy or patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a clinical care pathway for schizophrenia: a before and after study in 114 patients. Steinacher, B., Mausolff, L., Gusy, B.[2022]

The study highlights the need for individualized care pathways for inpatients with schizophrenia, as opposed to a one-size-fits-all approach, emphasizing the importance of tailoring treatment to each patient's unique needs.

Key barriers to developing effective care pathways for mental health services were identified, including the necessity for workforce consent and commitment, indicating that successful implementation will require addressing these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues for the development of care pathways in mental health services. Jones, A., Kamath, PD.[2019]

A patient-centered approach to treating schizophrenia, which includes simplifying medication regimens and involving patients in decision-making, can lead to improved clinical and functional outcomes.

Incorporating psychosocial interventions alongside medication may further enhance the effectiveness of treatment for individuals with schizophrenia, addressing their cognitive, behavioral, and emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia. Harvey, PD.[2021]

Citations

1. healthandjusticejournal.biomedcentral.com healthandjusticejournal.biomedcentral.com/articles/10.1186/s40352-025-00315-x

Forging new paths in the development of community mental ... The proposed study will examine the capacity of Forging New Paths (FNP), a novel criminogenic-focused group intervention developed for individuals with SMI.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39794641/

Forging new paths in the development of community mental ... The proposed study will examine the capacity of Forging New Paths (FNP), a novel criminogenic-focused group intervention developed for individuals with SMI.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06290648

NCT06290648 | Forging New Paths: Building Interventions ... The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal ...

4. researchgate.net researchgate.net/publication/387934916_Forging_new_paths_in_the_development_of_community_mental_health_interventions_for_people_with_mental_illness_at_risk_of_criminal_legal_system_contact

(PDF) Forging new paths in the development of community ... This study will examine the extent to which FNP is able to engage its primary (aggression and community tenure) and secondary (criminal ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06290648/forging-new-paths-building-interventions-to-treat-criminogenic-needs-in-community-based-mental-health-settings

Forging New Paths: Building Interventions to Treat ... The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/48/NCT06290648/ICF_000.pdf

Forging New Paths: Building Interventions to Treat ... The purpose of this research study is to develop a new program for people with mental illnesses and examine its effectiveness. The study is interested in ...

7. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1177/0890117119847584?download=true

Forging New Paths Between Social Determinism and Well- ... This editorial argues that we must think more deliberately about the causal chain that links neighborly social support and collective well-being if we are ever ...