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

Anxiety Clinical Trial

Official title:

Multisite Randomized Controlled Trial of Comprehensive Trauma Informed Reentry Services for Moderate to High Risk Youth Releasing From State Prisons

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04785677
• Other study ID #: STUDY00001064
• Secondary ID: 2019-MU-CX-0065
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 402
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Anxiety
• Coping Skills
• Depression
• Depressive Symptoms
• Housing Problems
• Impulsive Behavior
• Occupational Stress
• Psychological Distress
• Recidivism
• Stress
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Institute for Justice Research and Development	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	depressive symptoms	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
Other	depressive symptoms	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
Other	depressive symptoms	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
Other	anxiety symptoms	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
Other	anxiety symptoms	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
Other	anxiety symptoms	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
Other	incidence of substance use disorder	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
Other	incidence of substance use disorder	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
Other	incidence of substance use disorder	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
Other	coping self-efficacy	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
Other	coping self-efficacy	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
Other	coping self-efficacy	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
Other	Impulsivity	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
Other	Impulsivity	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
Other	Impulsivity	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
Other	psychological well-being	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
Other	psychological well-being	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
Other	psychological well-being	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
Primary	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.	4 months post release
Primary	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.	8 months post release
Primary	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	4 months post release
Primary	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	8 months post release
Secondary	Recidivism-violation	Number of days to reincarceration for a technical violation.	1 year post release
Secondary	Recidivism-violation	Number of days to reincarceration for a technical violation.	2 year post release
Secondary	Recidivism-violation	Number of days to reincarceration for a technical violation.	3 year post release
Secondary	Recidivism-new crime	Number of days to reincarceration for a new crime.	1 year post release
Secondary	Recidivism-new crime	Number of days to reincarceration for a new crime.	2 year post release
Secondary	Recidivism-new crime	Number of days to reincarceration for a new crime.	3 year post release