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Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration

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ClinicalTrials.gov Identifier: NCT04785677
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Carrie Pettus-Davis, Florida State University

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Resiliency in Stressful Experiences (RISE) Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Comprehensive Trauma-Based Reentry Program
Participants will complete up to19 session comprehensive trauma-based reentry program.
Behavioral: Resiliency in Stressful Experiences (RISE) 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 Name: Comprehensive Trauma-Based Reentry Program

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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


Secondary Outcome Measures :
  1. Recidivism-violation [ Time Frame: 1 year post release ]
    Number of days to reincarceration for a technical violation.

  2. Recidivism-violation [ Time Frame: 2 year post release ]
    Number of days to reincarceration for a technical violation.

  3. Recidivism-violation [ Time Frame: 3 year post release ]
    Number of days to reincarceration for a technical violation.

  4. Recidivism-new crime [ Time Frame: 1 year post release ]
    Number of days to reincarceration for a new crime.

  5. Recidivism-new crime [ Time Frame: 2 year post release ]
    Number of days to reincarceration for a new crime.

  6. Recidivism-new crime [ Time Frame: 3 year post release ]
    Number of days to reincarceration for a new crime.


Other Outcome Measures:
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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.

  17. 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.

  18. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785677


Contacts
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Contact: Kerensa Lockwood, PhD 850-644-4753 klockwood@fsu.edu

Locations
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United States, Florida
Institute for Justice Research and Development Recruiting
Tallahassee, Florida, United States, 32310
Contact: Kerensa P Lockwood, PhD    850-644-4753    klockwood@fsu.edu   
Sponsors and Collaborators
Florida State University
Investigators
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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
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Responsible Party: Carrie Pettus-Davis, Associate Professor; Founder and Executive Director Institute of Justice Research & Development, Florida State University
ClinicalTrials.gov Identifier: NCT04785677    
Other Study ID Numbers: STUDY00001064
2019-MU-CX-0065 ( Other Grant/Funding Number: National Institute of Justice )
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be accessible for at least 6 years after the primary analyses have been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carrie Pettus-Davis, Florida State University:
employment stability
Housing Stability
Reentry
Trauma
psychological wel-being
Additional relevant MeSH terms:
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Disease
Occupational Stress
Stress Disorders, Traumatic
Depression
Aggression
Impulsive Behavior
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms
Occupational Diseases
Stress, Psychological