Clinical trial NCT04386681: Re-entry Continuum for Brain Injury
Official title: Re-entry Continuum for Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Recidivism
Keywords: Offenders
Lead sponsor: Rehabilitation Hospital of Indiana
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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 eight 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)

Primary outcomes:
measure: Change in Brain Injury Coping Skills Questionnaire (BICS-Q)
timeFrame: within 2 weeks, 3 months
measure: Change in Buss Perry Aggression Questionnaire (AQ)
timeFrame: within 2 weeks, 3 months
measure: Change in Attributions of Intent Hostility Questionnaire (AIHQ)
timeFrame: within 2 weeks, 3 months
measure: Change in Participation Assessment with Combined Tools - Objective (PART-O)
timeFrame: 3 months, 1 year
measure: Change in Survey of Unmet Needs and Services Utilized (SUNSU)
timeFrame: 3 months, 1 year
measure: Change in Recidivism
timeFrame: 1 year after release, 2 years after release, 3 years after release
measure: Change in Behavioral Infractions
timeFrame: 3 months
measure: Change in Employment
timeFrame: Prior to release, 1 year after release, 2 years after release, and 3 years after release
measure: Change in Violent Rearrests
timeFrame: 1 year after release, 2 years after release, 3 years after release
Secondary outcomes:
measure: Level of Service Inventory - Revised (LSI-R)
timeFrame: within 2 weeks
measure: Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: within 2 weeks, 3 months, 1 year
Other outcomes:
Locations:
city: Greencastle
country: United States
facility: Putnamville Correctional Facility
state: Indiana
Study officials:
affiliation: Indiana University
name: Devan Parrott, PhD
role: PRINCIPAL_INVESTIGATOR
References: