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NCT Number: NCT05708092

NRF for Improved Re-Entry Outcomes for Offenders With Brain Injury (Brain Injury RE)

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).

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Non-English Speaking
  • Under 18 years old

Treatment and study plan

NeuroResource Facilitation (NRF)

Behavioral

NRF is defined as a specialized service that promotes access to services and coordinates care specific to the needs of individuals with brain injury.

Possible resources include vocational services, medical assistance, Social Security (SSI or SSDI if appropriate), and other organizations that can support reentry. If needed to gain access to services and organizations, the facilitator will also provide participants with a summary that includes results from brain injury screenings questionnaire, neurocognitive (thinking abilities) tests, and symptoms. The researchers will share information and coordinate with prison and parole staff about participation in the study. Participant's information will also be shared with resources that could help participants after release, such as funding sources and brain injury services. After release from SCI, the NRF facilitator will assist the participant with all the preparation and logistics associated with the resources the participant applied to.

Primary outcomes

  1. Number of Recidivism

    Time frame: 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.

  2. Number of Recidivism

    Time frame: 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.

Secondary outcomes

  1. Number of Productive Activities Hours

    Time frame: up to 36 months post release

    Productive Activities Hours include competitive employment (hours worked), and volunteer work (hours worked), brain injury clubhouses (hours attended), vocational training program (hours attended), and education (hours attended).

  2. Number or Participants Engaged in Productive Activity

    Time frame: up to 36 months post release

    The number of participants who engage in vocational training program or education activity at end of program.

  3. Number of Participants Engaged with Services

    Time frame: up to 36 months post release

    Engagement with Services. Engagement with Services includes community-based specialized NeuroRehabilitation services (physical therapy, occupational therapy, speech therapy, cognitive rehabilitation therapy, neuropsychology), and vocational rehabilitation services (job development, job placement, job coaching).

  4. Number of Participants Connected to Health/Medical Resources

    Time frame: up to 36 months post release

    The connection to Health/Medical resources will also be measured, "safety net" resources (SNAP, MA, SSI, food bank, etc).

  5. Number of participants in Community Support

    Time frame: up to 36 months post release

    Community Support - Participation in support groups and recovery resources, including religious activities, recreation, and access to transportation.

  6. Number of Participants in Stable Housing

    Time frame: up to 36 months post release

    Community Support - whether the ex-offender has stable housing

  7. Number of Parole Obligations Met

    Time frame: up to 36 months post release

    Parole Obligations - the extent to which the ex- offender has satisfied the obligations of Parole will be tracked, such as whether they have completed all mandated treatment

  8. Number of Participants Discharged from Supervision

    Time frame: up to 36 months post release

    Number of participants that have been or (are likely to be) discharged from supervision.

  9. Date of Reception

    Time frame: up to 36 months post release

    The day on which an individual was initially received into the custody

  10. Date Committed

    Time frame: up to 36 months post release

    The day on which an individual was committed to sentenced

  11. Date of entry into Department of Corrections

    Time frame: up to 36 months post release

    The day on which an individual was admitted into the Department of Corrections

  12. Number of Participants with particular Classification of Offense

    Time frame: up to 36 months post release

    Number of Participants with particular Classification of Offense as listed by the Department of Corrections

  13. Number of participants who are Guilty but mentally ill

    Time frame: up to 36 months post release

    Number of participants who are guilty but mentally ill

  14. Number of Participants Recommended for aftercare

    Time frame: up to 36 months post release

    Number of Participants Recommended to receive aftercare

  15. Status of Participants after Program completion

    Time frame: up to 36 months post release

    Status of Participants after Program completions as determined by the Department of Corrections

  16. Program category

    Time frame: up to 36 months post release

    Program category as as determined by the Department of Corrections

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Brain Injury Association of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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