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

NCT06290648 | Active Not Recruiting DMC

• 2 other identifiers: 22-08685R34MH130555
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Illness

Outcome Measures

Primary Outcomes (3)

• Change in Levels of Aggression Score from Baseline to 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.

  Baseline, Month 3

• Change in Levels of Aggression Score From Baseline to 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.

  Baseline, Month 6

• Community Tenure

  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).

  Month 3 through Month 9

Secondary Outcomes (2)

• Change in Overall Criminal Attitudes Score

  Baseline, Month 3

• Change in Overall Impulsivity Score

  Baseline, Month 3

Study Arms (2)

Experimental: Forging New Paths + Usual Care

EXPERIMENTAL

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

Behavioral: Forging New Paths

Control: Usual Care Alone

NO INTERVENTION

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

Interventions

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.

Experimental: Forging New Paths + Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

• Bryant, F. B., & Smith, B. D. (2001). Refining the architecture of aggression: A measurement model for the Buss-Perry Aggression Questionnaire. Journal of Research in Personality, 35(2), 138-167.

  BACKGROUND

• Mills JF, Kroner DG, Forth AE. Measures of Criminal Attitudes and Associates (MCAA): development, factor structure, reliability, and validity. Assessment. 2002 Sep;9(3):240-53. doi: 10.1177/1073191102009003003.

  PMID: 12216781 BACKGROUND

• Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.

  PMID: 8778124 BACKGROUND

• Wilson AB, Bonfine N, Phillips J, Swaine J, Scanlon F, Parisi A, Ginley C, Morgan R. Forging new paths in the development of community mental health interventions for people with mental illness at risk of criminal legal system contact. Health Justice. 2025 Jan 11;13(1):3. doi: 10.1186/s40352-025-00315-x.

  PMID: 39794641 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Amy Wilson, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: April 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The NIMH National Data Archives policies will dictate when and for how long de-identified data will be available.
• Access Criteria: The NIMH National Data Archives policies will dictate criteria for accessing data shored on the National Data Archive.

Locations

US (1)