Skip to main content
OpenTrials
Completed

NCT Number: NCT06290648

Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings

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 system contact. The main question[s] it aims to answer are:

1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure). 2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)

Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

The failure of traditional mental health services to significantly reduce the disproportionate involvement of people with serious mental illnesses (MI) in the criminal justice system highlights a basic but overlooked fact: mental illness is not a primary driver of criminal justice involvement. Research has consistently shown that people with mental illness face the same risk factors for justice involvement (i.e., "criminogenic" rick factors) as those without mental illnesses. Research has also found that justice-involved people with MI have high levels of criminogenic risk factors and that these risk factors mediate their risk of recidivism. Yet, most interventions for justice-involved people with MI do not target criminogenic risk factors as a goal of treatment.

This gap between research and service provision represents untapped potential to reduce rates of justice involvement among people with MI by expanding their continuum of services to include interventions that directly target criminogenic risk factors. Given that up to 50% of people with MI receiving treatment in the community-based mental health system have had some criminal justice system involvement, developing criminogenic-focused interventions designed specifically for delivery in community mental health settings has great potential to optimize their potential impact, both in terms of numbers of people with MI who can benefit and in terms of potential reductions in future criminal justice involvement.

This study will engage a pilot effectiveness trial of a newly developed intervention to examine the extent to which Forging New Paths (FNP) impacts its intended targets (mediating mechanisms) and outcomes among individuals with MI who have been involved in the criminal justice system receiving services through the community mental health system. The study will use a randomized controlled design to assign participants to one of the two study arms: 1) the study intervention FNP and usual care (experimental condition) or 2) usual care alone (control condition). This small scale randomized controlled trial explores the potential effectiveness of FNP at improving outcomes (aggression and community tenure) and engaging treatment targets (impulsivity and criminal attitudes).

All study participants will complete a screening interview to determine study eligibility. Participants who meet the study eligibility criteria will be randomized into one of the two study arms. All participants who are randomized to a study arm will complete up to three additional interviews: the baseline interview and 3- and 6-month follow-up interviews. Additionally, administrative data related study outcomes is collected at the 9-month time point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 years or older,
  • have a diagnosis of schizophrenia spectrum and other psychotic disorders or major depression or bipolar disorder, ( - have a 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 and,
  • have moderate or higher levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI).

Exclusion criteria

  • an intellectual or developmental disability,
  • incarceration at the point of study enrollment,
  • non-English speakers.

Treatment and study plan

Forging New Paths

Behavioral

The study intervention is Forging New Paths (FNP) a newly developed intervention for people with mental illness with criminal legal system involvement that is designed to be delivered in community mental health settings. FNP combines Cognitive Behavioral Treatment (CBT) techniques with social learning principles in a group format. The intervention is organized into a modular format to create a flexible intervention structure. It includes 5 treatment modules each consisting of two to four group sessions for a total of 14-16 sessions, which may be delivered over multiple meetings at the facilitators' discretion. The intervention is designed to be delivered to 8-12 people by two intervention facilitators. It can be delivered in person, virtually, or in a hybrid format.

Primary outcomes

  1. Change in Levels of Aggression Score from Baseline to Month 3

    Time frame: Baseline, Month 3

    Aggression Questionnaire (Bryant & Smith, 2001) - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present.

  2. Change in Levels of Aggression Score From Baseline to Month 6

    Time frame: Baseline, Month 6

    Aggression Questionnaire (Bryant & Smith, 2001) - Short Form is a 12-item measure with four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 6-point Likert scale. Scores range from 12 to 72. The higher the score the more aggression present.

  3. Community Tenure

    Time frame: Month 3 through Month 9

    A dichotomous variable indicating any disruption in a person's tenure in living in the community. A disruption includes any new criminal convictions or any inpatient hospitalization for any psychiatric reason during the study follow-up period (i.e., the period extending from the 3-month follow-up period through the 9-month follow-up period).

Secondary outcomes

  1. Change in Overall Criminal Attitudes Score

    Time frame: Baseline, Month 3

    The Measure of Criminal Attitudes and Associates (MCAA) Part B, is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates. Scores range from 0 to 46. Lower scores indicate lower levels of criminal attitudes.

  2. Change in Overall Impulsivity Score

    Time frame: Baseline, Month 3

    Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure (Patton & Barratt, 1995). Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity. The total score ranges from 30 to 120. Lower scores indicate lower levels of impulsiveness.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: FNP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.