Re-entry Continuum for Brain Injury

NCT ID: NCT04386681

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2027-01-01

Brief Summary

The overall research objectives of the proposed project are to decrease the rate of recidivism, defined as returning to incarceration within three years of release, as well as reduce the number of violent offenses, through the successful implementation of a continuum of services that addresses the unique needs of the TBI population. RHI, in partnership with PCF and IU, will work together to accomplish these goals. To meet study objectives, this randomized controlled trial (RCT) will enroll 102 individuals with TBI who will be randomized into the Reentry Continuum for Brain Injury (RCBI) intervention or a TAU-CG. Participants will be screened for TBI eight months prior to release from PCF. Upon consenting to participate, all subjects will be evaluated before, during, and after the intervention and recidivism data will be collected through IDOC's Data Analysis and Technology Department.

Detailed Description

Specific aims of the current proposal are as follows:

Aim 1. To examine differences in recidivism [return to incarceration within 3 years] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG.

Hypothesis 1 (H1): Participants in the RCBI group will demonstrate a lower proportion of recidivating participants than the TAU-CG one year, two years, and three years post release.

Aim 2. To examine differences in violent offenses [number of pre-release violent behavioral infractions; number of post-release felonies committed and their classifications] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG during 3 months pre-release, and one, two, and three years post-release.

Hypothesis 2A (H2A): Participants in the RCBI group will demonstrate lower rates of in-prison violent behavioral infractions between enrollment and release than participants in the control group.

Hypothesis 2B (H2B): Participants in the RCBI will commit fewer and less serious level felonies post-release than participants in the TAU-CG 1, 2, and 3 years post-release demonstrated by a lower proportion of RCBI offenders committing violent crimes than TAU-CG.

Aim 3. Examine group differences in coping [Brain Injury Coping Skills Questionnaire], aggression [Buss Perry Aggression Questionnaire], community integration [Participation Assessment with Recombined Tools-Objective], and number of basic needs unmet [Survey of Unmet Needs and Services] at time of release and 1-year post-release as well as employment [Employment acquisition and sustainability] 1, 2, and 3 years post-release.

Hypothesis 3A (H3A): Participants in the treatment group will show better scores on measures of coping and aggression compared to controls at time of release.

Hypothesis 3B (H3B): The RCBI group will show a higher proportion of participants obtaining employment compared to the TAU-CG as well as higher employment durations (total months showing employment data) one year, two years, and three years post release and better community integration one-year post release.

Hypothesis 3C (H3C): Participants in the treatment group will show lower rates of unmet needs compared to the control group one-year post release.

Aim 4 (Exploratory). Identify which factors predict recidivism in the TBI population and investigate their relationship with a validated measure of recidivism risk [Level of Service Inventory-Revised7].

Hypothesis 4 (H4): While it is hypothesized that group assignment (RCBI vs. TAU-CG) in combination with criminality risk and select demographic, injury, and/or social variables will contribute significantly to a model predicting three-year recidivism outcome, a specific model is not hypothesized and detection of specific contributing variables will be exploratory.

Conditions

Traumatic Brain Injury; Recidivism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RCBI

Receiving RCBI intervention, including BICS, ICAN, and RF.

Group Type: EXPERIMENTAL

Reentry Continuum for Brain Injury (RCBI)

Intervention Type: BEHAVIORAL

Pre-Release RCBI Treatment Procedures (BICS and ICAN). BICS: consists of 12 weekly two- hour sessions. Sessions focus on brain injury education, coping skills for the various symptoms of brain injury, depression management, stress management, and self- advocacy.

ICAN: delivered once a week for 6 weeks for 2 hours per session. ICAN primarily focuses on poor perspective-taking and inability to make social inferences about others' behaviors that are related to negative attributions, and employs role playing exercises and a novel perspective-positioning technique to elicit affective and cognitive empathy to alter negative attributions and reduce anger.

Post-Release RCBI Resource Facilitation. Working with their resource facilitator, alongside their corrections case manager, to work on brain injury specific reentry planning, resource, and needs identification.

Treatment as usual- Control group

Not receiving the RCBI intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reentry Continuum for Brain Injury (RCBI)

Pre-Release RCBI Treatment Procedures (BICS and ICAN). BICS: consists of 12 weekly two- hour sessions. Sessions focus on brain injury education, coping skills for the various symptoms of brain injury, depression management, stress management, and self- advocacy.

ICAN: delivered once a week for 6 weeks for 2 hours per session. ICAN primarily focuses on poor perspective-taking and inability to make social inferences about others' behaviors that are related to negative attributions, and employs role playing exercises and a novel perspective-positioning technique to elicit affective and cognitive empathy to alter negative attributions and reduce anger.

Post-Release RCBI Resource Facilitation. Working with their resource facilitator, alongside their corrections case manager, to work on brain injury specific reentry planning, resource, and needs identification.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of moderate to severe TBI
• Ages 18 and older
• Offenders currently serving their sentence at PCF in Greencastle, Indiana
• Approximately twelve or less months remaining in their sentence, but no fewer than 5 months remaining in sentence.

Exclusion Criteria

• In restricted housing (e.g., solitary confinement)
• Inability to comprehend the study
• Individuals requiring a legally authorized representative (LAR)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rehabilitation Hospital of Indiana

OTHER

Sponsor Role: lead

Responsible Party

Devan Parrott

Director of the Research Training and Outcome Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devan Parrott, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Putnamville Correctional Facility

Greencastle, Indiana, United States

Countries

United States

Other Identifiers

1909189045

Identifier Type: -

Identifier Source: org_study_id