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Not recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06290648

Conditions

Mental Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Forging New Paths

Study Details

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. 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.

Conditions

Mental Illness

Study ID

NCT06290648

Start date

Apr 1, 2024

Status verified date

Jun, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Forging New Paths + Usual Care

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

no intervention: Control: Usual Care Alone

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

Interventions

Forging New Paths

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 outcome measure

  • Change in Levels of Aggression Score from Baseline to Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change in Levels of Aggression Score From Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]
  • Community Tenure [ Time Frame: Month 3 through Month 9 ]

Central Contacts and Locations

Central contacts

Amy Wilson, PhD

919-962-3598amyblank@email.unc.edu

Jonathan Phillips, PhD

phil0309@d.umn.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 13, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2024-06-13.