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RCBI Program for TBI Recidivism Reduction (RCBI Trial)
N/A
Recruiting
Led By Devan Parrott, PhD
Research Sponsored by Rehabilitation Hospital of Indiana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18 and older
Be older than 18 years old
Must not have
Individuals requiring a legally authorized representative (LAR)
Inability to comprehend the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 weeks, 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help people with brain injuries who are being released from prison by providing a special program that supports their unique needs. The goal is to reduce their chances of going back to prison and committing violent crimes by offering tailored services that help them manage their behavior and integrate into the community.
Who is the study for?
This trial is for adults with a history of moderate to severe traumatic brain injury (TBI) who are currently serving sentences at PCF in Greencastle, Indiana and have 5 to 8 months left in their sentence. It's not for those in solitary confinement or unable to understand the study.
What is being tested?
The trial tests if the Reentry Continuum for Brain Injury (RCBI) program can reduce re-incarceration and violent offenses among TBI patients post-release. Participants will be randomly assigned to RCBI or typical aftercare and tracked for three years.
What are the potential side effects?
Since this intervention involves social support services rather than medication, traditional side effects aren't expected. However, participants may experience varying psychological impacts from involvement in the program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need someone legally authorized to make decisions for me.
Select...
I understand the details of the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Attributions of Intent Hostility Questionnaire (AIHQ)
Change in Behavioral Infractions
Change in Brain Injury Coping Skills Questionnaire (BICS-Q)
+6 moreSecondary study objectives
Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Level of Service Inventory - Revised (LSI-R)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RCBIExperimental Treatment1 Intervention
Receiving RCBI intervention, including BICS, ICAN, and RF.
Group II: Treatment as usual- Control groupActive Control1 Intervention
Not receiving the RCBI intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Traumatic Brain Injury (TBI) include multidisciplinary rehabilitation, cognitive-behavioral therapy (CBT), and community-based support services. Multidisciplinary rehabilitation involves a team of healthcare professionals who address the physical, cognitive, and emotional aspects of TBI, promoting overall recovery and functional independence.
CBT helps patients modify negative thought patterns and behaviors, improving coping strategies and reducing symptoms of anxiety and depression. Community-based support services provide tailored assistance to help individuals reintegrate into society, addressing unique needs such as vocational training, social skills development, and mental health support.
These treatments are crucial for TBI patients as they facilitate comprehensive recovery, enhance quality of life, and reduce the risk of recidivism by addressing the multifaceted challenges faced by individuals with TBI.
The effectiveness of traumatic brain injury rehabilitation: a review.Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Neurotherapeutic capacity of P7C3 agents for the treatment of Traumatic Brain Injury.
The effectiveness of traumatic brain injury rehabilitation: a review.Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Neurotherapeutic capacity of P7C3 agents for the treatment of Traumatic Brain Injury.
Find a Location
Who is running the clinical trial?
Rehabilitation Hospital of IndianaLead Sponsor
12 Previous Clinical Trials
5,462 Total Patients Enrolled
Devan Parrott, PhDPrincipal Investigator - Indiana University
Rehabilitation Hospital of Indiana
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need someone legally authorized to make decisions for me.I am 18 years old or older.I understand the details of the study.
Research Study Groups:
This trial has the following groups:- Group 1: RCBI
- Group 2: Treatment as usual- Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.