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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05708092
Enrollment
1022
Registered
2023-02-01
Start date
2022-03-22
Completion date
2026-12-31
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALNeuroResource Facilitation (NRF)

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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
Brain Injury Association of Pennsylvania
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Recidivismat year 1According 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

MeasureTime frameDescription
Number of Productive Activities Hoursup to 36 months post releaseProductive 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).
Number or Participants Engaged in Productive Activityup to 36 months post releaseThe number of participants who engage in vocational training program or education activity at end of program.
Number of Participants Engaged with Servicesup to 36 months post releaseEngagement 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).
Number of Participants Connected to Health/Medical Resourcesup to 36 months post releaseThe connection to Health/Medical resources will also be measured, "safety net" resources (SNAP, MA, SSI, food bank, etc).
Number of participants in Community Supportup to 36 months post releaseCommunity Support - Participation in support groups and recovery resources, including religious activities, recreation, and access to transportation.
Number of Participants in Stable Housingup to 36 months post releaseCommunity Support - whether the ex-offender has stable housing
Number of Parole Obligations Metup to 36 months post releaseParole 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
Number of Participants Discharged from Supervisionup to 36 months post releaseNumber of participants that have been or (are likely to be) discharged from supervision.
Date of Receptionup to 36 months post releaseThe day on which an individual was initially received into the custody
Date Committedup to 36 months post releaseThe day on which an individual was committed to sentenced
Date of entry into Department of Correctionsup to 36 months post releaseThe day on which an individual was admitted into the Department of Corrections
Number of Participants with particular Classification of Offenseup to 36 months post releaseNumber of Participants with particular Classification of Offense as listed by the Department of Corrections
Number of participants who are Guilty but mentally illup to 36 months post releaseNumber of participants who are guilty but mentally ill
Number of Participants Recommended for aftercareup to 36 months post releaseNumber of Participants Recommended to receive aftercare
Status of Participants after Program completionup to 36 months post releaseStatus of Participants after Program completions as determined by the Department of Corrections
Program categoryup to 36 months post releaseProgram category as as determined by the Department of Corrections

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMaria Kajankova, PhD

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026