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临床试验/NCT03713398
NCT03713398已完成不适用

Improving Mental Health Services for Prisoners With Serious Mental Illnesses

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
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

Interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with serious mental illness (SMI) because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison, including improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes).

详细描述

Interventions are urgently needed to improve the delivery and impact of mental health services for persons with serious mental illnesses (SMI) in prison. Treatments addressing the symptoms of mental illness form a critical component of the continuum of services needed by prisoners with SMI. However, a growing body of literature shows that mental health treatments need to be combined with treatments that directly address criminogenic risk factors (i.e., those factors most closely associated with criminal activities). Despite promising evidence, interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with SMI because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison. This small-scale randomized controlled trail (RCT) explores the potential effectiveness of T4C-SMI towards improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes). The study will also examine whether the treatment targets for T4C-SMI mediate the intervention's impact on outcomes.

The long-term goal is to grow the evidence-base for interventions with the capacity to improve prison and community-reentry outcomes for persons with SMI. This study will provide the data needed to implement a rigorous RCT in a future study and supports NIMH's mission to develop innovative interventions in mental health services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • aged 18 years or older
  • have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features
  • have moderate to high risk levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
  • have at least one year or more remaining on their prison sentence at the time of the screening interview

排除标准

  • has participated in T4C-SMI within 6 months prior to study

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 - 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 - 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.

Number of Participants With Post Test Behavioral Infractions

时间窗: End of intervention through Month 9, approximately 6 months total

Number of participants who have at least 1 behavioral infraction following the intervention. Prison records used to ascertain the number of participants who receive behavioral infractions.

Median Number of Days in Administrative Segregation

时间窗: End of intervention through Month 9, approximately 6 months total

Prison records will be used to determine the total number of days participants are placed in administrative segregation.

次要结局

  • Change in Overall Impulsivity Score(Baseline, Month 3)
  • Change in Overall Interpersonal Problem Solving 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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