- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04785677
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The five-year study is a two-armed, randomized controlled trial evaluating the effectiveness of a comprehensive trauma-based reentry program for young men assessed as moderate to high risk for recidivism as they are released to the community. Four Hundred young males who were released from one of ten Florida prisons into our target counties were randomly assigned to receive a comprehensive trauma-based reentry program or treatment as usual. The effectiveness of the reentry program was evaluated on mechanisms of change (trauma symptoms, coping, impulsivity, and aggression), community stability (housing, employment), and recidivism.
Research questions are: Does a comprehensive trauma-based research program improve key mechanisms of change for moderate to high-risk young males? Does a comprehensive trauma-based reentry program improve community stability for moderate to high-risk young males? Does a comprehensive trauma-based reentry program decrease rates of recidivism for moderate to high-risk young males? Research questions 1 and 2 were analyzed using ANCOVA, and Research Question 3 will be analyzed using survival analysis. We also used a Research-to-Practice Feedback Loop to catalyze rapid assessment of intervention and implementation refinement to increase participant responsivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tallahassee, Florida, United States, 32310
- Institute for Justice Research and Development
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: Comprehensive Trauma-Based Reentry Program
Participants will complete up to19 session comprehensive trauma-based reentry program.
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Housing Stability
Time Frame: 4 months post release
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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.
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4 months post release
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Housing Stability
Time Frame: 8 months post release
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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.
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8 months post release
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Employment Stability
Time Frame: 4 months post release
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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
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4 months post release
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Employment Stability
Time Frame: 8 months post release
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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
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8 months post release
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Brief Symptom Inventory
Time Frame: 4 months post release
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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.
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4 months post release
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Brief Symptom Inventory
Time Frame: 8 months post release
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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.
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8 months post release
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Mini International Neuropsychiatric Interview
Time Frame: 4 months post release
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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.
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4 months post release
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recidivism-violation
Time Frame: 1 year post release
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Number of days to reincarceration for a technical violation.
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1 year post release
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Recidivism-violation
Time Frame: 2 year post release
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Number of days to reincarceration for a technical violation.
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2 year post release
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Recidivism-violation
Time Frame: 3 year post release
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Number of days to reincarceration for a technical violation.
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3 year post release
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Recidivism-new Crime
Time Frame: 1 year post release
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Number of days to reincarceration for a new crime.
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1 year post release
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Recidivism-new Crime
Time Frame: 2 year post release
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Number of days to reincarceration for a new crime.
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2 year post release
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Recidivism-new Crime
Time Frame: 3 year post release
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Number of days to reincarceration for a new crime.
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3 year post release
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: 8 months post release
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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.
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8 months post release
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Anxiety Symptoms
Time Frame: 8 months post release
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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.
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8 months post release
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Incidence of Substance Use Disorder
Time Frame: 8 months post release
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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.
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8 months post release
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Coping Self-Efficacy Scale
Time Frame: 4 months post release
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Utilizing the Coping Self-Efficacy Scale (CSES) to assess coping self-efficacy.
The CSES is an 26-item self-report tool that asks respondents to indicate if they feel they can do accomplish 26 specific things if when they are having problems.
Responses are based on an 11-point Likert scale (0 = "Cannot do at all" to 10 = "Certain can do").
The CSES provides subscale scores on dimensions of problem-focused coping, stopping unpleasant emotions and thoughts, and social support as well as a total coping self-efficacy score that is calculated based on a sum of all items.
Problem focused subscale scores range from 0 to 60, emotion-focused subscale scores range from 0 to 40, and social support subscale scores range from 0 to 30.
The total coping self-efficacy score ranges from 0 to 260.
Higher scores indicate higher levels of coping self-efficacy.
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4 months post release
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Coping Self-efficacy
Time Frame: 8 months post release
|
he CSES is an 26-item self-report tool that asks respondents to indicate if they feel they can do accomplish 26 specific things if when they are having problems.
Responses are based on an 11-point Likert scale (0 = "Cannot do at all" to 10 = "Certain can do").
The CSES provides subscale scores on dimensions of problem-focused coping, stopping unpleasant emotions and thoughts, and social support as well as a total coping self-efficacy score that is calculated based on a sum of all items.
Problem focused subscale scores range from 0 to 60, emotion-focused subscale scores range from 0 to 40, and social support subscale scores range from 0 to 30.
The total coping self-efficacy score ranges from 0 to 260.
Higher scores indicate higher levels of coping self-efficacy.
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8 months post release
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Barratt Impulsivity Scale
Time Frame: 4 months post release
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Utilizing the Barratt Impulsivity Scale (BIS) to assess 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).
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.
Scores range from 30 to 120.
A higher score indicates greater impulsivity.
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4 months post release
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Barratt Impulsivity Scale
Time Frame: 8 months post release
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Utilizing the Barratt Impulsivity Scale (BIS) to assess 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).
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.
Scores range from 30 to 120.
A higher score indicates greater impulsivity.
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8 months post release
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Ryff Psychological Wellbeing Index
Time Frame: 4 months post release
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Utilizing the Ryff Psychological Wellbeing Index to assess participant wellbeing.
The Ryff is an 18-item self-report tool that asks respondents to indicate how strongly they agree or disagree with 18 statements.
Responses are based on a seven-point Likert scale (1 = "strongly agree" to 7 = "strongly disagree").
The Ryff provides subscale scores on dimensions of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance as well as a global wellbeing index that is calculated based on a sum of all items.
Subscale scores range from 3 to 21 and the global wellbeing scores range from 18 to 126.
Higher scores indicate higher levels of wellbeing.
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4 months post release
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Ryff Psychological Wellbeing Index
Time Frame: 8 months post release
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Utilizing the Ryff Psychological Wellbeing Index to assess participant wellbeing.
The Ryff is an 18-item self-report tool that asks respondents to indicate how strongly they agree or disagree with 18 statements.
Responses are based on a seven-point Likert scale (1 = "strongly agree" to 7 = "strongly disagree").
The Ryff provides subscale scores on dimensions of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance as well as a global wellbeing index that is calculated based on a sum of all items.
Subscale scores range from 3 to 21 and the global wellbeing scores range from 18 to 126.
Higher scores indicate higher levels of wellbeing.
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8 months post release
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Collaborators and Investigators
Sponsor
Collaborators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Aberrant Motor Behavior in Dementia
- Mental Disorders
- Behavioral Symptoms
- Chemically-Induced Disorders
- Stress, Psychological
- Occupational Diseases
- Behavior
- Social Behavior
- Criminal Behavior
- Occupational Stress
- Anxiety Disorders
- Depression
- Substance-Related Disorders
- Wounds and Injuries
- Aggression
- Stress Disorders, Traumatic
- Impulsive Behavior
- Stress Disorders, Traumatic, Acute
- Recidivism
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)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
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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