NCT04785677

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

February 5, 2021

Results QC Date

March 7, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

employment stabilityHousing StabilityReentryTraumapsychological wel-being

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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

    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

    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.

    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.

    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.

    4 months post release

Secondary Outcomes (6)

  • Recidivism-violation

    1 year post release

  • Recidivism-violation

    2 year post release

  • Recidivism-violation

    3 year post release

  • Recidivism-new Crime

    1 year post release

  • Recidivism-new Crime

    2 year post release

  • +1 more secondary outcomes

Other Outcomes (9)

  • Depressive Symptoms

    8 months post release

  • Anxiety Symptoms

    8 months post release

  • Incidence of Substance Use Disorder

    8 months post release

  • +6 more other outcomes

Study Arms (2)

Comprehensive Trauma-Based Reentry Program

EXPERIMENTAL

Participants will complete up to19 session comprehensive trauma-based reentry program.

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.

Interventions

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.

Also known as: Comprehensive Trauma-Based Reentry Program
Comprehensive Trauma-Based Reentry Program

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Justice Research and Development

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Stress Disorders, TraumaticStress Disorders, Traumatic, AcuteDepressionAnxiety DisordersSubstance-Related DisordersAggressionImpulsive BehaviorRecidivismOccupational StressWounds and Injuries

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorChemically-Induced DisordersAberrant Motor Behavior in DementiaSocial BehaviorCriminal BehaviorOccupational DiseasesStress, Psychological

Limitations and Caveats

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.

Results Point of Contact

Title
Stephen Tripodi
Organization
Florida State University

Study Officials

  • Carrie Pettus-Davis, PhD

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

    PRINCIPAL INVESTIGATOR
  • Stephen Tripodi, PhD

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

    PRINCIPAL INVESTIGATOR
  • Tanya Renn, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor;

Study Record Dates

First Submitted

February 5, 2021

First Posted

March 8, 2021

Study Start

February 9, 2021

Primary Completion

May 30, 2023

Study Completion

June 30, 2024

Last Updated

March 11, 2026

Results First Posted

October 29, 2025

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be accessible for at least 6 years after the primary analyses have been published.

Locations