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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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 groups in NCT04785677
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.

9 Feb 202130 Jun 2024

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.
More trials run by Florida State UniversityThe sponsor's other registered studies.
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)

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
ClinicalTrials.gov ID: NCT04785677
Acronym / sponsor ID: STUDY00001064
Conditions: Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms, Anxiety, Substance Use, Aggression
Keywords: employment stability, Housing Stability, Reentry, Trauma, psychological wel-being
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: U.S. Department of Justice
Study start: 9 Feb 2021 (actual)
Primary completion: 30 May 2023 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 8 Mar 2021 (actual)
Results: Posted 29 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Comprehensive Trauma-Based Reentry Program	Experimental	Behavioral: Resiliency in Stressful Experiences (RISE) ProgramParticipants will complete up to19 session comprehensive trauma-based reentry 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.

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resiliency in Stressful Experiences (RISE) ProgramAlso: Comprehensive Trauma-Based Reentry ProgramThe 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.	Behavioural	Comprehensive Trauma-Based Reentry Program

Primary outcome

Housing Stability
Time frame: 4 months post release
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.
Housing Stability
Time frame: 8 months post release
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.
Employment Stability
Time frame: 4 months post release
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
Employment Stability
Time frame: 8 months post release
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
Brief Symptom Inventory
Time frame: 4 months post release
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.
Brief Symptom Inventory
Time frame: 8 months post release
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.
Mini International Neuropsychiatric Interview
Time frame: 4 months post release
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.

3 secondary outcomes

Recidivism
Time frame: 1 year post release
Recidivism
Time frame: 2 year post release
Recidivism
Time frame: 3 year post release

Results and safety

Results posted to the registry on 29 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comprehensive Trauma-Based Reentry Program	196	28
Treatment as Usual (TAU)	207	179

Primary outcome: Housing Stability

Time frame: 4 months post release. Count of participants. Unit: Participants

Measure	Treatment Group n = 196	Control Group n = 207
Stable Housing	17	65
Not Housing Stable	7	23
Non-Responsive	172	119

Population analysed: Treatment group is treatment of the treated: Those who completed at least 70% of RISE programming.

Primary outcome: Housing Stability

Time frame: 8 months post release. Count of participants. Unit: Participants

Measure	Treatment Group n = 196	Control Group n = 207
Stable	18	60
Not Housing Stable	8	29
Non-responsive	170	118

Population analysed: Treatment group is treatment of the treated: those who completed at least 70% of programming

Primary outcome: Employment Stability

Time frame: 4 months post release. Count of participants. Unit: Participants

Measure	Comprehensive Trauma-Based Reentry Program n = 196	Treatment as Usual (TAU) n = 207
Employed	16	67
Not Employed	7	18
Non-Responsive	173	122

Population analysed: Treatment group is treatment of the treated: Those who completed at least 70% of programming

Primary outcome: Employment Stability

Time frame: 8 months post release. Count of participants. Unit: Participants

Measure	Comprehensive Trauma-Based Reentry Program n = 196	Treatment as Usual (TAU) n = 207
Employed	22	69
Not Employed	4	18
Non-Responsive	170	120

Population analysed: Treatment group is treatment of the treated: Those who completed at least 70% or programming

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 196 (0%)	0 of 196 (0%)	0 of 196
Control Group	0 of 207 (0%)	0 of 207 (0%)	0 of 207

Limitations and caveats (from the sponsor): The primary limitation is that there is a relatively small percentage of subjects in the treatment group that completed treatment, although this is a common limitation is reentry work.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carrie Pettus-Davis, PhD principal investigator

Florida State University College of Social Work, Institute of Justice Research & Development

Stephen Tripodi, PhD principal investigator

Florida State University College of Social Work, Institute of Justice Research & Development

Tanya Renn, PhD principal investigator

Florida State University College of Social Work, Institute of Justice Research & Development

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Housing Stability (time frame: 4 months post release). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04785677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.