Trial Outcomes & Findings for Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration (NCT NCT04785677)

Last Updated: 2025-10-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

403 participants

Primary outcome timeframe

4 months post release

Results posted on

2025-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Comprehensive Trauma-Based Reentry Program Participants will complete up to19 session comprehensive trauma-based reentry program. 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.	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.
Overall Study STARTED	196	207
Overall Study COMPLETED	28	179
Overall Study NOT COMPLETED	168	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data missing on 24 participants due to data collection error.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comprehensive Trauma-Based Reentry Program n=196 Participants Participants will complete up to19 session comprehensive trauma-based reentry program. 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.	Treatment as Usual (TAU) n=207 Participants Participants will be receive all reentry services normally eligible to receive by the state or the community to which they are released.	Total n=403 Participants Total of all reporting groups
Age, Continuous	28.07 years STANDARD_DEVIATION 4.703 • n=196 Participants	28.27 years STANDARD_DEVIATION 4.664 • n=207 Participants	28.17 years STANDARD_DEVIATION 4.68 • n=403 Participants
Sex: Female, Male Female	0 Participants n=196 Participants	0 Participants n=207 Participants	0 Participants n=403 Participants
Sex: Female, Male Male	196 Participants n=196 Participants	207 Participants n=207 Participants	403 Participants n=403 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=196 Participants	9 Participants n=207 Participants	15 Participants n=403 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=196 Participants	197 Participants n=207 Participants	387 Participants n=403 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=196 Participants	1 Participants n=207 Participants	1 Participants n=403 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=196 Participants	2 Participants n=207 Participants	3 Participants n=403 Participants
Race (NIH/OMB) Asian	1 Participants n=196 Participants	0 Participants n=207 Participants	1 Participants n=403 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=196 Participants	2 Participants n=207 Participants	2 Participants n=403 Participants
Race (NIH/OMB) Black or African American	125 Participants n=196 Participants	120 Participants n=207 Participants	245 Participants n=403 Participants
Race (NIH/OMB) White	53 Participants n=196 Participants	64 Participants n=207 Participants	117 Participants n=403 Participants
Race (NIH/OMB) More than one race	13 Participants n=196 Participants	19 Participants n=207 Participants	32 Participants n=403 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=196 Participants	0 Participants n=207 Participants	3 Participants n=403 Participants
Region of Enrollment United States	196 Participants n=196 Participants	207 Participants n=207 Participants	403 Participants n=403 Participants
BSI: Depression	.265 units on a scale STANDARD_DEVIATION .502 • n=196 Participants	.304 units on a scale STANDARD_DEVIATION .538 • n=207 Participants	.285 units on a scale STANDARD_DEVIATION .521 • n=403 Participants
BSI: Anxiety	.310 units on a scale STANDARD_DEVIATION .554 • n=196 Participants	.370 units on a scale STANDARD_DEVIATION .574 • n=207 Participants	.340 units on a scale STANDARD_DEVIATION .564 • n=403 Participants
Barratt Impulsivity Scale	63.45 units on a scale STANDARD_DEVIATION 9.11 • n=181 Participants • Data missing on 24 participants due to data collection error.	63.27 units on a scale STANDARD_DEVIATION 9.79 • n=196 Participants • Data missing on 24 participants due to data collection error.	63.36 units on a scale STANDARD_DEVIATION 9.46 • n=377 Participants • Data missing on 24 participants due to data collection error.
BSI: Substance Use Disorder Yes	138 Participants n=196 Participants	150 Participants n=207 Participants	288 Participants n=403 Participants
BSI: Substance Use Disorder No	58 Participants n=196 Participants	57 Participants n=207 Participants	115 Participants n=403 Participants
Coping Self-Efficacy: Problem-Focused Coping	45.67 units on a scale STANDARD_DEVIATION 8.25 • n=196 Participants	44.14 units on a scale STANDARD_DEVIATION 9.32 • n=207 Participants	44.88 units on a scale STANDARD_DEVIATION 8.84 • n=403 Participants
Coping Self-Efficacy: Stop Unpleasant Emotions and Thoughts	30.28 units on a scale STANDARD_DEVIATION 6.25 • n=196 Participants	28.95 units on a scale STANDARD_DEVIATION 7.06 • n=207 Participants	29.59 units on a scale STANDARD_DEVIATION 6.76 • n=403 Participants
Coping Self-Efficacy: Get Support from Family and Friends	21.33 units on a scale STANDARD_DEVIATION 5.77 • n=196 Participants	20.75 units on a scale STANDARD_DEVIATION 5.88 • n=207 Participants	21.03 units on a scale STANDARD_DEVIATION 5.82 • n=403 Participants
Ryff Psychological Well-Being: Autonomy	35.16 units on a scale STANDARD_DEVIATION 3.76 • n=196 Participants	35.07 units on a scale STANDARD_DEVIATION 4.12 • n=207 Participants	35.11 units on a scale STANDARD_DEVIATION 3.94 • n=403 Participants
Ryff Psychological Well-Being: Environmental Mastery	32.38 units on a scale STANDARD_DEVIATION 4.58 • n=196 Participants	32.49 units on a scale STANDARD_DEVIATION 4.91 • n=207 Participants	32.44 units on a scale STANDARD_DEVIATION 4.75 • n=403 Participants
Ryff Psychological Well-Being: Personal Growth	33.79 units on a scale STANDARD_DEVIATION 3.88 • n=196 Participants	33.97 units on a scale STANDARD_DEVIATION 3.98 • n=207 Participants	33.89 units on a scale STANDARD_DEVIATION 3.93 • n=403 Participants
Ryff Psychological Well-Being: Relations to Others	32.43 units on a scale STANDARD_DEVIATION 4.74 • n=196 Participants	33.22 units on a scale STANDARD_DEVIATION 4.38 • n=207 Participants	32.84 units on a scale STANDARD_DEVIATION 4.57 • n=403 Participants
Ryff Psychological Well-Being: Purpose in Life	34.53 units on a scale STANDARD_DEVIATION 4.44 • n=196 Participants	34.70 units on a scale STANDARD_DEVIATION 3.63 • n=207 Participants	34.62 units on a scale STANDARD_DEVIATION 4.04 • n=403 Participants
Ryff Psychological Well-Being: Self-Acceptance	31.09 units on a scale STANDARD_DEVIATION 5.00 • n=196 Participants	30.68 units on a scale STANDARD_DEVIATION 5.00 • n=207 Participants	30.88 units on a scale STANDARD_DEVIATION 5.00 • n=403 Participants

PRIMARY outcome

Timeframe: 4 months post release

Population: Treatment group is treatment of the treated: Those who completed at least 70% of RISE programming.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=196 Participants Completed at least 70 percent of RISE programming	Control Group n=207 Participants Treatment As Usual
Housing Stability Stable Housing	17 Participants	65 Participants
Housing Stability Not Housing Stable	7 Participants	23 Participants
Housing Stability Non-Responsive	172 Participants	119 Participants

PRIMARY outcome

Timeframe: 8 months post release

Population: Treatment group is treatment of the treated: those who completed at least 70% of programming

Outcome measures

Outcome measures
Measure	Treatment Group n=196 Participants Completed at least 70 percent of RISE programming	Control Group n=207 Participants Treatment As Usual
Housing Stability Stable	18 Participants	60 Participants
Housing Stability Not Housing Stable	8 Participants	29 Participants
Housing Stability Non-responsive	170 Participants	118 Participants

PRIMARY outcome

Timeframe: 4 months post release

Population: Treatment group is treatment of the treated: Those who completed at least 70% of programming

Outcome measures

Outcome measures
Measure	Treatment Group n=196 Participants Completed at least 70 percent of RISE programming	Control Group n=207 Participants Treatment As Usual
Employment Stability Employed	16 Participants	67 Participants
Employment Stability Not Employed	7 Participants	18 Participants
Employment Stability Non-Responsive	173 Participants	122 Participants

PRIMARY outcome

Timeframe: 8 months post release

Population: Treatment group is treatment of the treated: Those who completed at least 70% or programming

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

Outcome measures

Outcome measures
Measure	Treatment Group n=196 Participants Completed at least 70 percent of RISE programming	Control Group n=207 Participants Treatment As Usual
Employment Stability Employed	22 Participants	69 Participants
Employment Stability Not Employed	4 Participants	18 Participants
Employment Stability Non-Responsive	170 Participants	120 Participants

PRIMARY outcome

Timeframe: 4 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 172 people excluded from the treatment group and 119 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=24 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Brief Symptom Inventory	.451 units on a scale Standard Deviation .804	.536 units on a scale Standard Deviation .813

PRIMARY outcome

Timeframe: 8 months post release

Outcome measures

Outcome measures
Measure	Treatment Group n=24 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Brief Symptom Inventory	.618 units on a scale Standard Deviation .932	.553 units on a scale Standard Deviation .789

PRIMARY outcome

Timeframe: 4 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 167 people excluded from the treatment group and 118 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=29 Participants Completed at least 70 percent of RISE programming	Control Group n=89 Participants Treatment As Usual
Mini International Neuropsychiatric Interview Substance Use Disorder	8 Participants	22 Participants
Mini International Neuropsychiatric Interview No Substance Use Disorder	21 Participants	67 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 170 people excluded from the treatment group and 117 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants Completed at least 70 percent of RISE programming	Control Group n=90 Participants Treatment As Usual
Depressive Symptoms	.730 score on a scale Standard Deviation .964	.440 score on a scale Standard Deviation .670

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 170 people excluded from the treatment group and 117 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants Completed at least 70 percent of RISE programming	Control Group n=90 Participants Treatment As Usual
Anxiety Symptoms	.60 units on a scale Standard Deviation 1.15	.574 units on a scale Standard Deviation .812

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 167 people excluded from the treatment group and 117 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=29 Participants Completed at least 70 percent of RISE programming	Control Group n=90 Participants Treatment As Usual
Incidence of Substance Use Disorder Substance Use Disorder	9 Participants	23 Participants
Incidence of Substance Use Disorder No Substance Use Disorder	20 Participants	67 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months post release

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=24 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Coping Self-Efficacy Scale Using Problem-Focused Coping	45.58 score on a scale Standard Deviation 8.43	43.52 score on a scale Standard Deviation 13.45
Coping Self-Efficacy Scale Stop Unpleasant emotions and thoughts	29.1667 score on a scale Standard Deviation 5.75339	29.4091 score on a scale Standard Deviation 9.03205
Coping Self-Efficacy Scale Get Support From Friends and Family	20.1250 score on a scale Standard Deviation 5.47177	20.6818 score on a scale Standard Deviation 7.89812

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 170 people excluded from the treatment group and 118 people excluded from the TAU control group.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants Completed at least 70 percent of RISE programming	Control Group n=89 Participants Treatment As Usual
Coping Self-efficacy Using Problem-Focused Coping	48.23 score on a scale Standard Deviation 10.03	44.93 score on a scale Standard Deviation 10.16
Coping Self-efficacy Stop Unpleasant Emotions and Thoughts	30.3462 score on a scale Standard Deviation 8.01470	29.0449 score on a scale Standard Deviation 8.76967
Coping Self-efficacy Get Support From Friends and Family	18.3846 score on a scale Standard Deviation 7.46232	19.8764 score on a scale Standard Deviation 7.20767

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months post release

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=24 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Barratt Impulsivity Scale	61.63 score on a scale Standard Deviation 8.49	61.63 score on a scale Standard Deviation 11.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 171 people excluded from the treatment group and 123 people excluded from the TAU control group.

Outcome measures

Outcome measures
Measure	Treatment Group n=25 Participants Completed at least 70 percent of RISE programming	Control Group n=84 Participants Treatment As Usual
Barratt Impulsivity Scale	59.96 score on a scale Standard Deviation 15.83	61.48 score on a scale Standard Deviation 12.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months post release

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=24 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Ryff Psychological Wellbeing Index Autonomy	35.9538 score on a scale Standard Deviation 3.85023	33.0000 score on a scale Standard Deviation 4.77396
Ryff Psychological Wellbeing Index Environmental Mastery	32.3333 score on a scale Standard Deviation 4.54606	31.0795 score on a scale Standard Deviation 5.69174
Ryff Psychological Wellbeing Index Personal Growth	33.7917 score on a scale Standard Deviation 4.54905	33.2386 score on a scale Standard Deviation 4.39695
Ryff Psychological Wellbeing Index Positive Relations to Others	32.3043 score on a scale Standard Deviation 3.48288	31.6782 score on a scale Standard Deviation 6.16912
Ryff Psychological Wellbeing Index Purpose in Life	35.2500 score on a scale Standard Deviation 3.57832	33.6705 score on a scale Standard Deviation 5.10065
Ryff Psychological Wellbeing Index Self-Acceptance	32.5000 score on a scale Standard Deviation 3.40077	30.2529 score on a scale Standard Deviation 5.43721

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months post release

Population: Analysis of the comprehensive trauma-based reentry program is of those who completed at least 70% of programming and who participated in 4 month post release interviews. Analysis of the treatment group is of those who participated in post-release interviews. There were 170 people excluded from the treatment group and 119 people excluded from the TAU control group.

Outcome measures

Outcome measures
Measure	Treatment Group n=26 Participants Completed at least 70 percent of RISE programming	Control Group n=88 Participants Treatment As Usual
Ryff Psychological Wellbeing Index Autonomy	34.6538 score on a scale Standard Deviation 5.38102	34.2414 score on a scale Standard Deviation 5.11488
Ryff Psychological Wellbeing Index Environmental Mastery	30.1154 score on a scale Standard Deviation 7.67503	31.1477 score on a scale Standard Deviation 6.34368
Ryff Psychological Wellbeing Index Personal Growth	34.8077 score on a scale Standard Deviation 4.73303	34.0909 score on a scale Standard Deviation 5.52244
Ryff Psychological Wellbeing Index Positive Relations to Others	31.2400 score on a scale Standard Deviation 6.51460	32.0568 score on a scale Standard Deviation 5.87486
Ryff Psychological Wellbeing Index Purpose in Life	32.7692 score on a scale Standard Deviation 6.48264	33.5909 score on a scale Standard Deviation 5.24708
Ryff Psychological Wellbeing Index Self-Acceptance	31.6800 score on a scale Standard Deviation 679902	30.5698 score on a scale Standard Deviation 6.69599

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Tripodi

Florida State University

Phone: 850-645-1572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place