Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
Primary Purpose
Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resiliency in Stressful Experiences (RISE) Program
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Traumatic focused on measuring employment stability, Housing Stability, Reentry, Trauma, psychological wel-being
Eligibility Criteria
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.
Sites / Locations
- Institute for Justice Research and Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Comprehensive Trauma-Based Reentry Program
Treatment as usual (TAU)
Arm Description
Participants will complete up to19 session comprehensive trauma-based reentry program.
Participants will be receive all reentry services normally eligible to receive by the state or the community to which they are released.
Outcomes
Primary Outcome Measures
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.
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.
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
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
Secondary Outcome Measures
Recidivism-violation
Number of days to reincarceration for a technical violation.
Recidivism-violation
Number of days to reincarceration for a technical violation.
Recidivism-violation
Number of days to reincarceration for a technical violation.
Recidivism-new crime
Number of days to reincarceration for a new crime.
Recidivism-new crime
Number of days to reincarceration for a new crime.
Recidivism-new crime
Number of days to reincarceration for a new crime.
Full Information
NCT ID
NCT04785677
First Posted
February 5, 2021
Last Updated
August 11, 2023
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT04785677
Brief Title
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
Official Title
Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Depressive Symptoms, Anxiety, Substance Use, Aggression, Coping Skills, Impulsive Behavior, Housing Problems, Recidivism, Stress, Occupational Stress, Psychological Distress
Keywords
employment stability, Housing Stability, Reentry, Trauma, psychological wel-being
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive Trauma-Based Reentry Program
Arm Type
Experimental
Arm Description
Participants will complete up to19 session comprehensive trauma-based reentry program.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Participants will be receive all reentry services normally eligible to receive by the state or the community to which they are released.
Intervention Type
Behavioral
Intervention Name(s)
Resiliency in Stressful Experiences (RISE) Program
Other Intervention Name(s)
Comprehensive Trauma-Based Reentry Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
housing stability
Description
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.
Time Frame
4 months post release
Title
housing stability
Description
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.
Time Frame
8 months post release
Title
employment stability
Description
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
Time Frame
4 months post release
Title
employment stability
Description
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
Time Frame
8 months post release
Secondary Outcome Measure Information:
Title
Recidivism-violation
Description
Number of days to reincarceration for a technical violation.
Time Frame
1 year post release
Title
Recidivism-violation
Description
Number of days to reincarceration for a technical violation.
Time Frame
2 year post release
Title
Recidivism-violation
Description
Number of days to reincarceration for a technical violation.
Time Frame
3 year post release
Title
Recidivism-new crime
Description
Number of days to reincarceration for a new crime.
Time Frame
1 year post release
Title
Recidivism-new crime
Description
Number of days to reincarceration for a new crime.
Time Frame
2 year post release
Title
Recidivism-new crime
Description
Number of days to reincarceration for a new crime.
Time Frame
3 year post release
Other Pre-specified Outcome Measures:
Title
depressive symptoms
Description
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.
Time Frame
2 weeks post release
Title
depressive symptoms
Description
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.
Time Frame
4 months post release
Title
depressive symptoms
Description
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.
Time Frame
8 months post release
Title
anxiety symptoms
Description
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.
Time Frame
2 weeks post release
Title
anxiety symptoms
Description
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.
Time Frame
4 months post release
Title
anxiety symptoms
Description
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.
Time Frame
8 months post release
Title
incidence of substance use disorder
Description
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.
Time Frame
2 weeks post release
Title
incidence of substance use disorder
Description
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.
Time Frame
4 months post release
Title
incidence of substance use disorder
Description
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.
Time Frame
8 months post release
Title
coping self-efficacy
Description
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.
Time Frame
2 weeks post release
Title
coping self-efficacy
Description
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.
Time Frame
4 months post release
Title
coping self-efficacy
Description
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.
Time Frame
8 months post release
Title
Impulsivity
Description
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).
Time Frame
2 weeks post release
Title
Impulsivity
Description
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).
Time Frame
4 months post release
Title
Impulsivity
Description
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).
Time Frame
8 months post release
Title
psychological well-being
Description
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.
Time Frame
2 weeks post release
Title
psychological well-being
Description
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.
Time Frame
4 months post release
Title
psychological well-being
Description
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.
Time Frame
8 months post release
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Pettus-Davis, PhD
Organizational Affiliation
Florida State University College of Social Work, Institute of Justice Research & Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Tripodi, PhD
Organizational Affiliation
Florida State University College of Social Work, Institute of Justice Research & Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanya Renn, PhD
Organizational Affiliation
Florida State University College of Social Work, Institute of Justice Research & Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Justice Research and Development
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32310
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
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