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

NCT05708092 | Active Not Recruiting

• 2 other identifiers: STUDY-21-005612020-75-CX-0007
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 2

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).

Conditions

Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Number of Productive Activities Hours

  up to 36 months post release

• Number or Participants Engaged in Productive Activity

  up to 36 months post release

• Number of Participants Engaged with Services

  up to 36 months post release

• Number of Participants Connected to Health/Medical Resources

  up to 36 months post release

• Number of participants in Community Support

  up to 36 months post release

Study Arms (2)

NeuroResource Facilitation

ACTIVE COMPARATOR

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)

Standard of Care

NO INTERVENTION

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.

Interventions

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.

NeuroResource Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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)

You may not qualify if:

• Non-English Speaking
• Under 18 years old

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Brain Injury Association of Pennsylvania: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10065, United States

Location

Brain Injury Association of Pennsylvania

Carlisle, Pennsylvania, 17015, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria Kajankova, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: March 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (2)