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Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration
NA trial testing Resiliency in Stressful Experiences (RISE) Program in Stress Disorders, Traumatic in 403 participants. Completed in 30 June 2024.
| Lead sponsor | Florida State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 403 |
| Start date | 9 February 2021 |
| Primary completion | 30 May 2023 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Florida State University
Adults 18 to 35, male only, with Stress Disorders, Traumatic or Stress Disorders, Traumatic, Acute. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 17 | |
| Control Group | 65 | |
| Treatment Group | 7 | |
| Control Group | 23 | |
| Treatment Group | 172 | |
| Control Group | 119 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 18 | |
| Control Group | 60 | |
| Treatment Group | 8 | |
| Control Group | 29 | |
| Treatment Group | 170 | |
| Control Group | 118 |
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
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 16 | |
| Treatment as Usual (TAU) | 67 | |
| Comprehensive Trauma-Based Reentry Program | 7 | |
| Treatment as Usual (TAU) | 18 | |
| Comprehensive Trauma-Based Reentry Program | 173 | |
| Treatment as Usual (TAU) | 122 |
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
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 22 | |
| Treatment as Usual (TAU) | 69 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 4 | |
| Treatment as Usual (TAU) | 18 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 170 | |
| Treatment as Usual (TAU) | 120 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | .451 | ± .804 |
| Treatment as Usual (TAU) | .536 | ± .813 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | .618 | ± .932 |
| Treatment as Usual (TAU) | .553 | ± .789 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 8 | |
| Treatment as Usual (TAU) | 22 | |
| Comprehensive Trauma-Based Reentry Program | 21 | |
| Treatment as Usual (TAU) | 67 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | .730 | ± .964 |
| Treatment as Usual (TAU) | .440 | ± .670 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | .60 | ± 1.15 |
| Treatment as Usual (TAU) | .574 | ± .812 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 9 | |
| Treatment as Usual (TAU) | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 20 | |
| Treatment as Usual (TAU) | 67 |
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 sc
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 45.58 | ± 8.43 |
| Treatment as Usual (TAU) | 43.52 | ± 13.45 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 29.1667 | ± 5.75339 |
| Treatment as Usual (TAU) | 29.4091 | ± 9.03205 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 20.1250 | ± 5.47177 |
| Treatment as Usual (TAU) | 20.6818 | ± 7.89812 |
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
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 48.23 | ± 10.03 |
| Treatment as Usual (TAU) | 44.93 | ± 10.16 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 30.3462 | ± 8.01470 |
| Treatment as Usual (TAU) | 29.0449 | ± 8.76967 |
| Group | Value | 95% CI |
|---|---|---|
| Comprehensive Trauma-Based Reentry Program | 18.3846 | ± 7.46232 |
| Treatment as Usual (TAU) | 19.8764 | ± 7.20767 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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