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

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708092
• Other study ID #: STUDY-21-00561
• Secondary ID: 2020-75-CX-0007
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Annell Ovalles, MPH
• Phone: 212-241-4706
• Email: annell.ovalles[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 765
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• NeuroResource 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.

Locations

Country	Name	City	State
United States	Brain Injury Association of Pennsylvania	Carlisle	Pennsylvania
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Brain Injury Association of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Recidivism	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.	at year 1
Primary	Number of Recidivism	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.	at year 3
Secondary	Number of Productive Activities Hours	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).	up to 36 months post release
Secondary	Number or Participants Engaged in Productive Activity	The number of participants who engage in vocational training program or education activity at end of program.	up to 36 months post release
Secondary	Number of Participants Engaged with Services	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).	up to 36 months post release
Secondary	Number of Participants Connected to Health/Medical Resources	The connection to Health/Medical resources will also be measured, "safety net" resources (SNAP, MA, SSI, food bank, etc).	up to 36 months post release
Secondary	Number of participants in Community Support	Community Support - Participation in support groups and recovery resources, including religious activities, recreation, and access to transportation.	up to 36 months post release
Secondary	Number of Participants in Stable Housing	Community Support - whether the ex-offender has stable housing	up to 36 months post release
Secondary	Number of Parole Obligations Met	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	up to 36 months post release
Secondary	Number of Participants Discharged from Supervision	Number of participants that have been or (are likely to be) discharged from supervision.	up to 36 months post release
Secondary	Date of Reception	The day on which an individual was initially received into the custody	up to 36 months post release
Secondary	Date Committed	The day on which an individual was committed to sentenced	up to 36 months post release
Secondary	Date of entry into Department of Corrections	The day on which an individual was admitted into the Department of Corrections	up to 36 months post release
Secondary	Number of Participants with particular Classification of Offense	Number of Participants with particular Classification of Offense as listed by the Department of Corrections	up to 36 months post release
Secondary	Number of participants who are Guilty but mentally ill	Number of participants who are guilty but mentally ill	up to 36 months post release
Secondary	Number of Participants Recommended for aftercare	Number of Participants Recommended to receive aftercare	up to 36 months post release
Secondary	Status of Participants after Program completion	Status of Participants after Program completions as determined by the Department of Corrections	up to 36 months post release
Secondary	Program category	Program category as as determined by the Department of Corrections	up to 36 months post release