- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04785677
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
August 11, 2023 updated by: Stephen Tripodi, Florida State University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
402
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32310
- Institute for Justice Research and Development
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive Trauma-Based Reentry Program
Participants will complete up to19 session 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.
Other Names:
|
No Intervention: Treatment as usual (TAU)
Participants will be receive all reentry services normally eligible to receive by the state or the community to which they are released.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 months post release
|
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.
|
8 months post release
|
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
|
4 months post release
|
employment stability
Time Frame: 8 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
|
8 months post release
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recidivism-violation
Time Frame: 1 year post release
|
Number of days to reincarceration for a technical violation.
|
1 year post release
|
Recidivism-violation
Time Frame: 2 year post release
|
Number of days to reincarceration for a technical violation.
|
2 year post release
|
Recidivism-violation
Time Frame: 3 year post release
|
Number of days to reincarceration for a technical violation.
|
3 year post release
|
Recidivism-new crime
Time Frame: 1 year post release
|
Number of days to reincarceration for a new crime.
|
1 year post release
|
Recidivism-new crime
Time Frame: 2 year post release
|
Number of days to reincarceration for a new crime.
|
2 year post release
|
Recidivism-new crime
Time Frame: 3 year post release
|
Number of days to reincarceration for a new crime.
|
3 year post release
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depressive symptoms
Time Frame: 2 weeks post release
|
Depressive symptoms marked by dysphoric mood, inactivity, lack of interest, insomnia, feelings of worthlessness, diminished ability to think, and thoughts of suicide.
Depressive symptoms will be measured using the Brief Symptom Inventory, a 53-items with a 6 question sub-scale of depressive symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").The higher score the more depressive symptoms.
|
2 weeks post release
|
depressive symptoms
Time Frame: 4 months post release
|
Depressive symptoms marked by dysphoric mood, inactivity, lack of interest, insomnia, feelings of worthlessness, diminished ability to think, and thoughts of suicide.
Depressive symptoms will be measured using the Brief Symptom Inventory, a 53-items with a 6 question sub-scale of depressive symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").
The higher score the more depressive symptoms.
|
4 months post release
|
depressive symptoms
Time Frame: 8 months post release
|
Depressive symptoms marked by dysphoric mood, inactivity, lack of interest, insomnia, feelings of worthlessness, diminished ability to think, and thoughts of suicide.
Depressive symptoms will be measured using the Brief Symptom Inventory, a 53-items with a 6 question sub-scale of depressive symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").The higher score the more depressive symptoms.
|
8 months post release
|
anxiety symptoms
Time Frame: 2 weeks post release
|
Anxiety symptoms identified as apprehension or fear of impending actual or imagined danger, vulnerability, or uncertainty.
Anxiety Symptoms will be measured using the Brief Symptom Inventory is a 53-items with a 6 question sub-scale of anxiety symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").The higher score the more symptoms of anxiety.
|
2 weeks post release
|
anxiety symptoms
Time Frame: 4 months post release
|
Anxiety symptoms identified as apprehension or fear of impending actual or imagined danger, vulnerability, or uncertainty.
Anxiety Symptoms will be measured using the Brief Symptom Inventory is a 53-items with a 6 question sub-scale of anxiety symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").The higher score the more symptoms of anxiety.
|
4 months post release
|
anxiety symptoms
Time Frame: 8 months post release
|
Anxiety symptoms identified as apprehension or fear of impending actual or imagined danger, vulnerability, or uncertainty.
Anxiety Symptoms will be measured using the Brief Symptom Inventory is a 53-items with a 6 question sub-scale of anxiety symptoms were a respondent characterizes the intensity of distress (0 ="not at all" to 4="extremely").The higher score the more symptoms of anxiety.
|
8 months post release
|
incidence of substance use disorder
Time Frame: 2 weeks post release
|
A pathological pattern of impairment related to the overuse of, or dependence on, psychoactive drugs, prescription medications, or other substances.
A 9-item substance use disorder subscale of the MINI assesses current incidence of substance use disorders.
Items are rated on a dichotomous Yes/No scale and follow psychiatric guidelines of the DSM-5.
|
2 weeks post release
|
incidence of substance use disorder
Time Frame: 4 months post release
|
A pathological pattern of impairment related to the overuse of, or dependence on, psychoactive drugs, prescription medications, or other substances.
A 9-item substance use disorder subscale of the MINI assesses 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
|
incidence of substance use disorder
Time Frame: 8 months post release
|
A pathological pattern of impairment related to the overuse of, or dependence on, psychoactive drugs, prescription medications, or other substances.
A 9-item substance use disorder subscale of the MINI assesses current incidence of substance use disorders.
Items are rated on a dichotomous Yes/No scale and follow psychiatric guidelines of the DSM-5.
|
8 months post release
|
coping self-efficacy
Time Frame: 2 weeks post release
|
Self- efficacy is a cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect.
The 26-item Coping Self-Efficacy Scale assesses self-efficacy and confidence in coping with stress.
Participants pick a number from 0-10 with 0 being Cannot Do at All and 10 being Certain Can Do.
The higher the score, the higher the level of coping self-efficacy.
|
2 weeks post release
|
coping self-efficacy
Time Frame: 4 months post release
|
Self- efficacy is a cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect.
The 26-item Coping Self-Efficacy Scale assesses self-efficacy and confidence in coping with stress.
Participants pick a number from 0-10 with 0 being Cannot Do at All and 10 being Certain Can Do.
The higher the score, the higher the level of coping self-efficacy.
|
4 months post release
|
coping self-efficacy
Time Frame: 8 months post release
|
Self- efficacy is a cognitive mechanism based on expectations or beliefs about one's ability to perform actions necessary to produce a given effect.
The 26-item Coping Self-Efficacy Scale assesses self-efficacy and confidence in coping with stress.
Participants pick a number from 0-10 with 0 being Cannot Do at All and 10 being Certain Can Do.
The higher the score, the higher the level of coping self-efficacy.
|
8 months post release
|
Impulsivity
Time Frame: 2 weeks post release
|
Impulsivity is defined as a predisposition toward rapid, unplanned reactions to internal or external stimuli without regard to the negative consequences of these reactions to the impulsive individual or to others.
Impulsivity will be measured using the Barratt Impulsivity Scale (BIS).
The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences.
Participants select a number on the following scale.1 if you rarely or never act or think that way, 2 if you occasionally think that way, 3 if you often think that way, or 4 if you almost or always think that way.
A higher scores indicate greater impulsivity.
The BIS assesses general impulsiveness on six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).
|
2 weeks post release
|
Impulsivity
Time Frame: 4 months post release
|
Impulsivity is defined as a predisposition toward rapid, unplanned reactions to internal or external stimuli without regard to the negative consequences of these reactions to the impulsive individual or to others.
Impulsivity will be measured using the Barratt Impulsivity Scale (BIS).
The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences.
Participants select a number on the following scale.1 if you rarely or never act or think that way, 2 if you occasionally think that way, 3 if you often think that way, or 4 if you almost or always think that way.
A higher scores indicate greater impulsivity.
The BIS assesses general impulsiveness on six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).
|
4 months post release
|
Impulsivity
Time Frame: 8 months post release
|
Impulsivity is defined as a predisposition toward rapid, unplanned reactions to internal or external stimuli without regard to the negative consequences of these reactions to the impulsive individual or to others.
Impulsivity will be measured using the Barratt Impulsivity Scale (BIS).
The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences.
Participants select a number on the following scale.1 if you rarely or never act or think that way, 2 if you occasionally think that way, 3 if you often think that way, or 4 if you almost or always think that way.
A higher scores indicate greater impulsivity.
The BIS assesses general impulsiveness on six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).
|
8 months post release
|
psychological well-being
Time Frame: 2 weeks post release
|
Psychological Well-being is a complex combination of various psychological and personality characteristics.
It will be measured using the Ryff scale of psychological well-being, a 54- item inventory of six areas of psychological well-being.
Autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
|
2 weeks post release
|
psychological well-being
Time Frame: 4 months post release
|
Psychological Well-being is a complex combination of various psychological and personality characteristics.
It will be measured using the Ryff scale of psychological well-being, a 54- item inventory of six areas of psychological well-being.
Autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
|
4 months post release
|
psychological well-being
Time Frame: 8 months post release
|
Psychological Well-being is a complex combination of various psychological and personality characteristics.
It will be measured using the Ryff scale of psychological well-being, a 54- item inventory of six areas of psychological well-being.
Autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
|
8 months post release
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2021
Primary Completion (Actual)
May 30, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001064
- 2019-MU-CX-0065 (Other Grant/Funding Number: National Institute of Justice)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Data will be accessible for at least 6 years after the primary analyses have been published.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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