Stress Disorders, TraumaticNCT04785677
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
A study testing Resiliency in Stressful Experiences (RISE) Program in people with Stress Disorders, Traumatic and Stress Disorders, Traumatic, Acute, run by Florida State University at 1 site in United States.
Trial summary
The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms
- What is being tested?
- Resiliency in Stressful Experiences (RISE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 30 Jun 2024
- Phase
- Interventional
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 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males
- Ages 18-35
- Have experienced at least one lifetime traumatic event
- Released from incarceration to Suwanee, Leon, Duval or Columbia County, Florida.
- Conversational in English
- Being able to cognitively consent
Who cannot join
- Younger than 18 years old
- Older than 35 years old
- Has not experienced at least one lifetime traumatic event
- Not cognitively able to understand
- Not conversational in English
- Not releasing from incarceration to Suwanee, Leon, Duval or Columbia County, Florida.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Justice Research and Development
Tallahassee, Florida, 32310
About this study
Official title: Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.
Read the detailed description
The five-year study is a two-armed, randomized controlled trial evaluating the effectiveness of a comprehensive trauma-based reentry program for young men assessed as moderate to high risk for recidivism as they are released to the community. Four Hundred young males who were released from one of ten Florida prisons into our target counties were randomly assigned to receive a comprehensive trauma-based reentry program or treatment as usual. The effectiveness of the reentry program was evaluated on mechanisms of change (trauma symptoms, coping, impulsivity, and aggression), community stability (housing, employment), and recidivism.
Research questions are: Does a comprehensive trauma-based research program improve key mechanisms of change for moderate to high-risk young males? Does a comprehensive trauma-based reentry program improve community stability for moderate to high-risk young males? Does a comprehensive trauma-based reentry program decrease rates of recidivism for moderate to high-risk young males? Research questions 1 and 2 were analyzed using ANCOVA, and Research Question 3 will be analyzed using survival analysis. We also used a Research-to-Practice Feedback Loop to catalyze rapid assessment of intervention and implementation refinement to increase participant responsivity.
- Conditions
- Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms, Anxiety, Substance Use, Aggression
- Being tested
- Resiliency in Stressful Experiences (RISE) Program
- Keywords
- employment stability, Housing Stability, Reentry, Trauma, psychological wel-being
- Medical subject headings
- Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depression, Anxiety Disorders, Substance-Related Disorders, Aggression, Impulsive Behavior, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiliency in Stressful Experiences (RISE) ProgramBehavioural
Also called Comprehensive Trauma-Based Reentry Program
The Resiliency in Stressful Experiences (RISE) Program is a multi-phased comprehensive trauma based reentry program designed based on the transitional nature of reentry. Participants will receive up to 4 sessions prior to release and up tp 15 session post release from prison. The RISE program is a trauma intervention paired with reentry services, including housing support and employment assistance.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | Experimental | Participants will complete up to19 session comprehensive trauma-based reentry program. Receives: Behavioral: Resiliency in Stressful Experiences (RISE) Program |
| Treatment as usual (TAU) | No intervention | Participants will be receive all reentry services normally eligible to receive by the state or the community to which they are released. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Housing Stability
Stable housing was defined as living in one's own room, apartment, or house, or with family, with an expected duration of residence of 4 months or more, or tenancy rights. A 10- item measure will assess housing stability.
Measured: 4 months post release
Housing Stability
Stable housing was defined as living in one's own room, apartment, or house, or with family, with an expected duration of residence of 4 months or more, or tenancy rights. A 10- item measure will assess housing stability.
Measured: 8 months post release
Employment Stability
Employment Stability is measure on a continuum, based on the number of jobs held in the last 4 months and number of days worked at each Employment. The employment must be for at least 15 hours a week. A 10-item measure will assess employment stability
Measured: 4 months post release
Employment Stability
Employment Stability is based on the number of jobs held in the last 4 months and number of days worked at each Employment. The employment must be for at least 15 hours a week. A 10-item measure will assess employment stability
Measured: 8 months post release
Brief Symptom Inventory
Utilizing the Brief Symptom Inventory (BSI) to assess depression and anxiety symptoms in participants. The BSI is a 53-item self-report screening tool that asks respondents to rate their level of psychological distress over the past seven days based on a five-point Likert scale (0 = "not at all" to 5 = "extremely"). The BSI provides subscale scores on dimensions of somatization, depression, and anxiety as well as a Global Severity Index (GSI) that is calculated based on a sum of all items. Subscale scores range from 0 to 4. Higher scores on the BSI indicate higher levels of symptomology.
Measured: 4 months post release
Brief Symptom Inventory
Utilizing the Brief Symptom Inventory (BSI) to assess depression and anxiety symptoms in participants. The BSI is a 53-item self-report screening tool that asks respondents to rate their level of psychological distress over the past seven days based on a five-point Likert scale (0 = "not at all" to 5 = "extremely"). The BSI provides subscale scores on dimensions of somatization, depression, and anxiety as well as a Global Severity Index (GSI) that is calculated based on a sum of all items. Subscale scores range from 0 to 4. Higher scores on the BSI indicate higher levels of symptomology.
Measured: 8 months post release
Mini International Neuropsychiatric Interview
Utilizing the 9-item substance use disorder subscale of the MINI International Neuropsychiatric Interview (MINI) to assess current incidence of substance use disorders. Items are rated on a dichotomous Yes/No scale and follow psychiatric guidelines of the DSM-5.
Measured: 4 months post release
Secondary outcomes (3)
Recidivism
Number of days to reincarceration.
Measured: 1 year post release
Recidivism
Number of days to reincarceration.
Measured: 2 year post release
Recidivism
Number of days to reincarceration.
Measured: 3 year post release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start9 Feb 2021
- Primary completion30 May 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, TraumaticStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Principal investigator, Stephen Tripodi, Florida State University
- Investigators
- Carrie Pettus-Davis, PhD, Principal investigator, Florida State University College of Social Work, Institute of Justice Research & DevelopmentStephen Tripodi, PhD, Principal investigator, Florida State University College of Social Work, Institute of Justice Research & DevelopmentTanya Renn, PhD, Principal investigator, Florida State University College of Social Work, Institute of Justice Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785677
- Sponsor's protocol ID
- STUDY00001064
- Other IDs
- 2019-MU-CX-0065
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2021
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be considered for researchers and students, using the IJRD data sharing agreement. Data will be uploaded at the conclusion of the research to the National Archive of Criminal Justice Data, as required by the National Institute of Justice. Contact IJRD for additional information.