Re-entry Continuum for Brain Injury

NCT04386681 | Active Not Recruiting

• 1 other identifier: 1909189045
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Recidivism

Keywords

Offenders

Outcome Measures

Primary Outcomes (9)

• Change in Brain Injury Coping Skills Questionnaire (BICS-Q)

  Designed to measure self-efficacy related to brain injury. BICS-Q was designed based on Bandura's Guide for developing self-efficacy scales. Participants rate 20 items using a 5-point Likert-scale resulting in a total score. BICS-Q has shown significant change across BICS participants in multiple studies. Participants rate each statement from 0 (Not at all) to 4 (Extremely). Higher scores suggest greater self-efficacy.

  within 2 weeks, 3 months

• Change in Aggression Questionnaire (AQ)

  A standardized measure comprised of 34 statements to assess anger, hostile thoughts, and physical and verbal aggression.10 Participants rate statements using a 5-point scale (1 - Extremely uncharacteristic of me to 5 - Extremely characteristic of me). Raw and scaled scores (adjusted by age and gender) are provided for aggression subcomponents and total aggression. Total aggression will be used for our analyses. The AQ is a widely used measure, including for TBI studies.11 It has good test-retest reliability (.72-.80), and good internal consistency (.76-.94). Higher scores suggest higher aggression tendencies

  within 2 weeks, 3 months

• Change in Attributions of Intent Hostility Questionnaire (AIHQ)

  This consists of 5 written vignettes describing ambiguous actions/ situations (unclear intent behind actions). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by an independent rater; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended response).

  within 2 weeks, 3 months

• Change in Participation Assessment with Combined Tools - Objective (PART-O)

  This is a 17-item measure developed and validated by the NIDILRR-sponsored TBI Model Systems13 to evaluate participation in the community with three domains: Productivity, Social Relations, and Out and About. Each item is scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.

  3 months, 1 year

• Change in Survey of Unmet Needs and Services Utilized (SUNSU)

  This measure is designed to assess both the usage of and desire for services unique to brain injury. The SUNSU includes a comprehensive list of 27 service needs and results in two scores: the number of met needs and the number of unmet needs. The measure shows good internal consistency as well as validity when compared to other needs assessments in the brain injury population. Participants decide if they : currently want help for the need, currently receiving help for the need, or it is not a need at all.

  3 months, 1 year

• Change in Recidivism

  This is defined as return to incarceration within three years of release and is the primary outcome to be collected through the IDOC Research and Technology Division for all participants at three time points: one, two, and three years after release.

  1 year after release, 2 years after release, 3 years after release

• Change in Behavioral Infractions

  This is collected from PCF directly for each participant at time of release. The number and type of infractions will be counted between study enrollment and release.

  3 months

• Change in Employment

  This includes acquisition and sustainability (i.e., duration of employment) data will be collected through the IDOC Research and Technology Division for all offenders at three time points: one year, two years, and three years after release from IDOC.

  Prior to release, 1 year after release, 2 years after release, and 3 years after release

• Change in Violent Rearrests

  This is collected for each participant through the IDOC Data Analysis and Technology Department for all offenders at three time points: one year, two years, and three years after release from IDOC. Offenses are coded between 1 and 6 with 1 being the highest level of violence and 6 being the lowest level/non-violent. Type of offense in criminal history (violent vs. nonviolent) will also be collected as a covariate.

  1 year after release, 2 years after release, 3 years after release

Secondary Outcomes (2)

• Level of Service Inventory - Revised (LSI-R)

  within 2 weeks

• Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)

  within 2 weeks, 3 months, 1 year

Study Arms (2)

RCBI

EXPERIMENTAL

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

Behavioral: Reentry Continuum for Brain Injury (RCBI)

Treatment as usual- Control group

NO INTERVENTION

Not receiving the RCBI intervention

Interventions

Reentry Continuum for Brain Injury (RCBI) 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.

RCBI

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rehabilitation Hospital of Indiana: lead

Study Sites (1)

Putnamville Correctional Facility

Greencastle, Indiana, 46135, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Recidivism

Condition Hierarchy (Ancestors)

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

Study Officials

• Devan Parrott, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Research Training and Outcome Center

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 13, 2020
• Study Start: March 1, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)