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

Primary Purpose

Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroResource Facilitation (NRF)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting
  • Brain Injury Association of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NeuroResource Facilitation

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Number or Participants Engaged in Productive Activity
The number of participants who engage in vocational training program or education activity at end of program.
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).
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).
Number of participants in Community Support
Community Support - Participation in support groups and recovery resources, including religious activities, recreation, and access to transportation.
Number of Participants in Stable Housing
Community Support - whether the ex-offender has stable housing
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
Number of Participants Discharged from Supervision
Number of participants that have been or (are likely to be) discharged from supervision.
Date of Reception
The day on which an individual was initially received into the custody
Date Committed
The day on which an individual was committed to sentenced
Date of entry into Department of Corrections
The day on which an individual was admitted into the Department of Corrections
Number of Participants with particular Classification of Offense
Number of Participants with particular Classification of Offense as listed by the Department of Corrections
Number of participants who are Guilty but mentally ill
Number of participants who are guilty but mentally ill
Number of Participants Recommended for aftercare
Number of Participants Recommended to receive aftercare
Status of Participants after Program completion
Status of Participants after Program completions as determined by the Department of Corrections
Program category
Program category as as determined by the Department of Corrections

Full Information

First Posted
January 23, 2023
Last Updated
June 27, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Brain Injury Association of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05708092
Brief Title
NRF for Improved Re-Entry Outcomes for Offenders With Brain Injury (Brain Injury RE)
Official Title
NeuroResource Facilitation for Improved Re-Entry Outcomes for Offenders With Brain Injury: A Multi-Site Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Brain Injury Association of Pennsylvania

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
765 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroResource Facilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NeuroResource Facilitation (NRF)
Intervention Description
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 Outcome Measure Information:
Title
Number of Recidivism
Description
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.
Time Frame
at year 1
Title
Number of Recidivism
Description
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.
Time Frame
at year 3
Secondary Outcome Measure Information:
Title
Number of Productive Activities Hours
Description
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).
Time Frame
up to 36 months post release
Title
Number or Participants Engaged in Productive Activity
Description
The number of participants who engage in vocational training program or education activity at end of program.
Time Frame
up to 36 months post release
Title
Number of Participants Engaged with Services
Description
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).
Time Frame
up to 36 months post release
Title
Number of Participants Connected to Health/Medical Resources
Description
The connection to Health/Medical resources will also be measured, "safety net" resources (SNAP, MA, SSI, food bank, etc).
Time Frame
up to 36 months post release
Title
Number of participants in Community Support
Description
Community Support - Participation in support groups and recovery resources, including religious activities, recreation, and access to transportation.
Time Frame
up to 36 months post release
Title
Number of Participants in Stable Housing
Description
Community Support - whether the ex-offender has stable housing
Time Frame
up to 36 months post release
Title
Number of Parole Obligations Met
Description
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
Time Frame
up to 36 months post release
Title
Number of Participants Discharged from Supervision
Description
Number of participants that have been or (are likely to be) discharged from supervision.
Time Frame
up to 36 months post release
Title
Date of Reception
Description
The day on which an individual was initially received into the custody
Time Frame
up to 36 months post release
Title
Date Committed
Description
The day on which an individual was committed to sentenced
Time Frame
up to 36 months post release
Title
Date of entry into Department of Corrections
Description
The day on which an individual was admitted into the Department of Corrections
Time Frame
up to 36 months post release
Title
Number of Participants with particular Classification of Offense
Description
Number of Participants with particular Classification of Offense as listed by the Department of Corrections
Time Frame
up to 36 months post release
Title
Number of participants who are Guilty but mentally ill
Description
Number of participants who are guilty but mentally ill
Time Frame
up to 36 months post release
Title
Number of Participants Recommended for aftercare
Description
Number of Participants Recommended to receive aftercare
Time Frame
up to 36 months post release
Title
Status of Participants after Program completion
Description
Status of Participants after Program completions as determined by the Department of Corrections
Time Frame
up to 36 months post release
Title
Program category
Description
Program category as as determined by the Department of Corrections
Time Frame
up to 36 months post release

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annell Ovalles, MPH
Phone
212-241-4706
Email
annell.ovalles@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Kajankova, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annell Ovalles, MPH
Phone
212-241-4706
Email
annell.ovalles@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Maria Kajankova
Facility Name
Brain Injury Association of Pennsylvania
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew Nagele

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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