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

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).

Study Overview

• Status: Recruiting
• Conditions: Brain Injury
• Intervention / Treatment: Behavioral: NeuroResource Facilitation (NRF)

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.

• Study Type: Interventional
• Enrollment (Estimated): 765
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annell Ovalles, MPH; Phone Number: 212-241-4706; Email: annell.ovalles@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Annell Ovalles, MPH; Phone Number: 212-241-4706; Email: annell.ovalles@mountsinai.org
      • Principal Investigator: Maria Kajankova
  • Pennsylvania
    • Carlisle, Pennsylvania, United States, 17015
      • Recruiting
      • Brain Injury Association of Pennsylvania
      • Sub-Investigator: Drew Nagele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NeuroResource Facilitation; 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.	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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Number of Participants in Stable Housing	Community Support - whether the ex-offender has stable housing	up to 36 months post release
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
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
Date of Reception	The day on which an individual was initially received into the custody	up to 36 months post release
Date Committed	The day on which an individual was committed to sentenced	up to 36 months post release
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
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
Number of participants who are Guilty but mentally ill	Number of participants who are guilty but mentally ill	up to 36 months post release
Number of Participants Recommended for aftercare	Number of Participants Recommended to receive aftercare	up to 36 months post release
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
Program category	Program category as as determined by the Department of Corrections	up to 36 months post release

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Brain Injury Association of Pennsylvania
• Investigators: Principal Investigator: Maria Kajankova, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: STUDY-21-00561; 2020-75-CX-0007 (Other Grant/Funding Number: National Institute of Justice)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to maria.kajankova@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No