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

Sponsor
Florida State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04785677
Collaborator
(none)
402
1
2
40.6
9.9

Study Details

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
402 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 :
Feb 9, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. housing stability [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 [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 [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 [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 [1 year post release]

      Number of days to reincarceration for a technical violation.

    2. Recidivism-violation [2 year post release]

      Number of days to reincarceration for a technical violation.

    3. Recidivism-violation [3 year post release]

      Number of days to reincarceration for a technical violation.

    4. Recidivism-new crime [1 year post release]

      Number of days to reincarceration for a new crime.

    5. Recidivism-new crime [2 year post release]

      Number of days to reincarceration for a new crime.

    6. Recidivism-new crime [3 year post release]

      Number of days to reincarceration for a new crime.

    Other Outcome Measures

    1. depressive symptoms [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute for Justice Research and Development Tallahassee Florida United States 32310

    Sponsors and Collaborators

    • Florida State University

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Carrie Pettus-Davis, Associate Professor; Founder and Executive Director Institute of Justice Research & Development, Florida State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2022