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临床试验/NCT05708092
NCT05708092进行中(未招募)不适用

NeuroResource Facilitation for Improved Re-Entry Outcomes for Offenders With Brain Injury: A Multi-Site Randomized Controlled Trial

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 1,022 人开始时间: 2022年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,022
试验地点
2
主要终点
Number of Recidivism

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of NeuroResource Facilitation, a novel/innovative intervention, in reducing recidivism in offenders with brain injury (BI).

详细描述

The prevalence of brain injury (BI) is significantly greater in justice-involved populations, and a substantial proportion of prisoners have likely experienced a BI during their lifetime. A history of BI has a statistically significant association with increased use of correctional, medical and psychological services including crisis intervention; an increased frequency of institutional misconducts; and higher recidivism rates. Brain injury in justice-involved populations is frequently undiagnosed, and therefore untreated, which contributes to the cycle of recidivism. Identifying BI opens up new resources to ex- offenders that can more effectively help them to become productive in their lives in the community. In partnership with the Icahn School of Medicine at Mount Sinai, the Brain Injury Association of Pennsylvania, and the Pennsylvania Department of Corrections (PADOC), this project will implement a randomized clinical trial to determine if a case management intervention called Neurorehabilitation Facilitation (NRF) is effective in reducing recidivism by ten percent in offenders with acquired BI. Offenders in two Pennsylvania prisons (State Correctional Institution (SCI) sites in PA, SCI Phoenix, SCI Chester, SCI Frackville, and SCI Mahanoy) will be screened for BI and cognitive impairment, and those who screen positive will be randomized to receive the intervention or to receive standard of care (SoC). Two thirds of those randomized will receive the intervention and the remaining one third will serve as controls. All participants will be followed for up to three years following their release to examine the immediate and long-term reduction in recidivism.

The primary hypothesis is that NRF, as compared to SoC, will result in a 10% reduction in average 1-year recidivism, estimated by the 2013

Department of Corrections (DOC) report as 35-38%. Understanding that additional factors will contribute to the effect of NRF, the required sample was based on the primary analysis, a logistic regression of the binary response variable recidivism, adjusted for additional independent variables (described below) in the model with estimated R-squared=0.10. An effect size of 10% reduction corresponds to an odds ratio in this model of 0.643. With two thirds (67%) of cases randomized to NRF, and one third (33%) randomized to SoC, a total sample of N=688 provides 80% power at alpha set at 0.05. Anticipating that there will be a loss of approximately 10% of randomized cases to attrition, N=764 cases will be randomized, with n=509 cases randomized to NRF and 255 randomized to SoC.

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
Single (Investigator)

盲法说明

Only the follow up data collector will be blinded to the randomization assignment of all participants. At the beginning of each interview, the participant will be instructed to not share whether they were assigned to a NRF or SOC.

入排标准

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

入选标准

  • 18+ years old
  • Proficient in English
  • History of brain injury (OSU-TBI-ID)
  • Significant cognitive impairment (RBANS and Trails A&B)
  • Within 6 months of release
  • Returning to 6 county area (Bucks, Chester, Delaware, Montgomery, Philadelphia and Schuylkill)

排除标准

  • Non-English Speaking
  • Under 18 years old

研究组 & 干预措施

NeuroResource Facilitation

Active Comparator

As part of the NRF intervention group, participants will receive specialized care management, both in prison and after the participant goes home. While in the State Correctional Institution (SCI), participants will meet weekly to monthly depending on resource needs, and how close participant is to release with a NeuroResource Facilitator in person who will help participants to understand more about their challenges. Participants may also be referred to a group run by the Facilitator in conjunction with staff from the prison. The facilitator will also tell the participant about resources that are available to help after the participant's release and help participants get connected to them.

干预措施: NeuroResource Facilitation (NRF) (Behavioral)

Standard of Care

No Intervention

As part of the SoC, participants will receive the re-entry services normally receive if not in the study including (but not limited to) Treatment Services, Educational and Vocational Training, Mental Health Management, Reentry and Transitional Services, Population Management and Community Corrections.

结局指标

主要结局

Number of Recidivism

时间窗: at year 3

According to the PADOC, rearrest is measured as the first instance of arrest after inmates are released from state prison and reincarceration is measured as the first instance of returning to state prison after an offender is released from state prison. Overall recidivism is measured as the first instance of any type of rearrest or reincarceration after inmates are released from state prison.

Number of Recidivism

时间窗: at year 1

According to the PADOC, rearrest is measured as the first instance of arrest after inmates are released from state prison and reincarceration is measured as the first instance of returning to state prison after an offender is released from state prison. Overall recidivism is measured as the first instance of any type of rearrest or reincarceration after inmates are released from state prison.

次要结局

  • Number or Participants Engaged in Productive Activity(up to 36 months post release)
  • Number of Productive Activities Hours(up to 36 months post release)
  • Number of Participants in Stable Housing(up to 36 months post release)
  • Date of Reception(up to 36 months post release)
  • Date Committed(up to 36 months post release)
  • Date of entry into Department of Corrections(up to 36 months post release)
  • Number of Participants Connected to Health/Medical Resources(up to 36 months post release)
  • Number of participants in Community Support(up to 36 months post release)
  • Number of participants who are Guilty but mentally ill(up to 36 months post release)
  • Number of Participants Engaged with Services(up to 36 months post release)
  • Number of Parole Obligations Met(up to 36 months post release)
  • Number of Participants Discharged from Supervision(up to 36 months post release)
  • Number of Participants Recommended for aftercare(up to 36 months post release)
  • Number of Participants with particular Classification of Offense(up to 36 months post release)
  • Status of Participants after Program completion(up to 36 months post release)
  • Program category(up to 36 months post release)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Kajankova

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (2)

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