Brain InjuryNCT05708092
NRF for Improved Re-Entry Outcomes for Offenders With Brain Injury (Brain Injury RE)
A study testing NeuroResource Facilitation (NRF) in people with Brain Injury, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Brain Injury
- What is being tested?
- NeuroResource Facilitation (NRF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Non-English Speaking
- Under 18 years old
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brain Injury Association of Pennsylvania
Carlisle, Pennsylvania, 17015
Icahn School of Medicine at Mount Sinai
New York, New York, 10065
About this study
Official title: 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).
Read the 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.
- Conditions
- Brain Injury
- Being tested
- NeuroResource Facilitation (NRF)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroResource Facilitation (NRF)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at year 3
Secondary outcomes (16)
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: up to 36 months post release
Number of Participants in Stable Housing
Community Support - whether the ex-offender has stable housing
Measured: 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
Measured: 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.
Measured: up to 36 months post release
Date of Reception
The day on which an individual was initially received into the custody
Measured: up to 36 months post release
Date Committed
The day on which an individual was committed to sentenced
Measured: 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
Measured: 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
Measured: up to 36 months post release
Number of participants who are Guilty but mentally ill
Number of participants who are guilty but mentally ill
Measured: up to 36 months post release
Number of Participants Recommended for aftercare
Number of Participants Recommended to receive aftercare
Measured: 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
Measured: up to 36 months post release
Program category
Program category as as determined by the Department of Corrections
Measured: up to 36 months post release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start22 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Injury Association of Pennsylvania
- Responsible party
- Principal investigator, Maria Kajankova, Icahn School of Medicine at Mount Sinai
- Investigators
- Maria Kajankova, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708092
- Sponsor's protocol ID
- STUDY-21-00561
- Other IDs
- 2020-75-CX-0007
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Kajankova M, Ovalles A, Hicks AJ, Spielman L, Nagele D, Schmidt MJ, Vaccaro M, Del Pozzo J, Bucklen B, Gordon W. NeuroResource facilitation for improved re-entry outcomes for incarcerated individuals with Brain injury: Randomized controlled trial protocol. Contemp Clin Trials. 2026 Aug 10:108432. doi: 10.1016/j.cct.2026.108432. Online ahead of print.
PubMed 42575295
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroResource Facilitation for Improved Re-Entry Outcomes for Offenders With Brain Injury: A Multi-Site Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05708092
- Acronym / sponsor ID
- STUDY-21-00561
- Conditions
- Brain Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Brain Injury Association of Pennsylvania
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroResource Facilitation | Active comparator | Behavioral: NeuroResource Facilitation (NRF)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English Speaking
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | NeuroResource Facilitation |
Primary outcome
Number of Recidivism
Time frame: at year 1
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
Time frame: at year 3
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.
16 secondary outcomes
Number of Productive Activities Hours
Time frame: up to 36 months post release
Number or Participants Engaged in Productive Activity
Time frame: up to 36 months post release
Number of Participants Engaged with Services
Time frame: up to 36 months post release
Number of Participants Connected to Health/Medical Resources
Time frame: up to 36 months post release
Number of participants in Community Support
Time frame: up to 36 months post release
Number of Participants in Stable Housing
Time frame: up to 36 months post release
Number of Parole Obligations Met
Time frame: up to 36 months post release
Number of Participants Discharged from Supervision
Time frame: up to 36 months post release
Date of Reception
Time frame: up to 36 months post release
Date Committed
Time frame: up to 36 months post release
Date of entry into Department of Corrections
Time frame: up to 36 months post release
Number of Participants with particular Classification of Offense
Time frame: up to 36 months post release
Number of participants who are Guilty but mentally ill
Time frame: up to 36 months post release
Number of Participants Recommended for aftercare
Time frame: up to 36 months post release
Status of Participants after Program completion
Time frame: up to 36 months post release
Program category
Time frame: up to 36 months post release
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 42575295Kajankova M, Ovalles A, Hicks AJ, Spielman L, Nagele D, Schmidt MJ, Vaccaro M, Del Pozzo J, Bucklen B, Gordon W. NeuroResource facilitation for improved re-entry outcomes for incarcerated individuals with Brain injury: Randomized controlled trial protocol. Contemp Clin Trials. 2026 Aug 10:108432. doi: 10.1016/j.cct.2026.108432. Online ahead of print.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kajankova, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroResource Facilitation (NRF) in people with Brain Injury, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Recidivism (time frame: at year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.