跳至主要内容
临床试验/NCT06290648
NCT06290648已完成不适用

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

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Change in Levels of Aggression Score from Baseline to Month 3

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

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

研究组 & 干预措施

Control: Usual Care Alone

No Intervention

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

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.

干预措施: Forging New Paths (Behavioral)

结局指标

主要结局

Change in Levels of Aggression Score from Baseline to Month 3

时间窗: 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.

Change in Levels of Aggression Score From Baseline to Month 6

时间窗: 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.

Community Tenure

时间窗: 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).

次要结局

  • Change in Overall Impulsivity Score(Baseline, Month 3)
  • Change in Overall Criminal Attitudes Score(Baseline, Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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