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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05942469
Other study ID # STU00219630
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date October 31, 2025

Study information

Verified date March 2024
Source Northwestern University
Contact Amanda Summers, MA
Phone 3125035247
Email amanda.summers@northwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

FOREST is a positive emotion skills program designed to target mental health and coping needs for frontline violence prevention workers at READI Chicago. Ten skills are taught over a period of nine months during existing meetings and wellness activities, as well as in online modules in READI's Learning Management System (LMS). Through infusing the FOREST skills throughout READI, we hope to inspire organizational culture change that will emphasize the importance of wellbeing and enhance resilience, therefore reducing burnout and turnover.


Description:

All READI personnel will receive the FOREST program, including coaches, crew chiefs, outreach workers, managers, and supervisors at all sites and partner organizations delivering the READI program. Each month for 9 months there will be a focus on one to two positive emotion skills. The skill(s) of the month will be taught to the staff at each of the three READI sties (Austin, Englewood, and North Lawndale) separately on the first three Fridays of the month. These sessions will take place during existing one-hour wellness meetings/activities, and will be co-facilitated by Positive Emotion Ambassadors (PEAs; READI Staff members nominated to infuse the skills into READI culture) and Northwestern University. The skill sessions will include didactic content defining the skill and explaining the rationale for inclusion, as well as examples of existing research demonstrating the skills benefits. During the session the group will practice the skill together and discuss ways to use the skill in both work and personal situations. Throughout the month, PEAs will implement the FOREST skill of the month in other existing meetings, check-ins, and team outings Each of the 3 monthly site sessions will be observed by a member of the Implementation Resource Team (IRT) who will use a checklist to track that all core pieces of the skill training were delivered. Additionally, a PEA from a different site will observe each skill session to assess content alignment, engagement, and practice. The fourth Friday of the month the IRT will meet with the PEAs for additional training and support. These sessions will be audio recorded for qualitative data on facilitators and barriers to the skill. Each month a module in READI's learning management system (LMS) that covers that month's skill(s) will also become available. The LMS modules will contain skill-related content similar to what is taught in the skill sessions, including a thorough definition of the skill, examples of ways to utilize the skill, a review or summary of the skill, and several knowledge questions to check for comprehension. The LMS content may include text, audio, images, and video components. All READI staff will be required to complete the LMS FOREST skill module of the month, like any other required training rolled out at READI. Percentage of staff completing each LMS training will be tracked. Annual assessments to assess primary and secondary outcomes will be administered via REDCap. Annual interviews and focus groups will ask for feedback on implementation and content.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and over - Currently employed by Heartland Alliance/READI Chicago - Has internet access - Speaks and reads English Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
FOREST
The skill sessions will include didactic content defining the skill, rationale for including the skill in FOREST, and research demonstrating that practice of the skill increases positive emotion. In addition, the group will practice the skill together and will discuss ways to practice the skill at work as well as outside of work. Throughout the month, PEAs will implement the FOREST skill of the month in other existing meetings, check-ins, and team outings. Concurrently, a module in READI's learning management system (LMS) will become available. The LMS modules will contain skill-related content similar to what is taught in the skill sessions, including a thorough definition of the skill, examples of ways to utilize the skill, a review or summary of the skill, and several knowledge questions to check for comprehension. The LMS content may include text, audio, images, and video components.

Locations

Country Name City State
United States Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in burnout measured by the Maslach Burnout Inventory (MBI). The MBI evaluates burnout severity based on three aspects: emotional exhaustion, depersonalization, and lack of personal accomplishment, with higher scores on the emotional exhaustion and depersonalization subscales, and lower scores on the personal accomplishments subscale, indicating increased levels of burnout. Responses on the scale range from "never" to "every day." 12 months
Primary Increase in positive affect measured by PROMIS Short Form v1.0- Positive Affect 15a. PROMIS Positive Affect assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Responses options range from "Not at all" to "Very much" with higher scores indicate higher levels of positive affect. 12 months
Primary Decrease in depression measured by PROMIS Short Form v1.0- Depression 4a. PROMIS Depression Bank assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Response options range from "Never" to "Always" with higher scores indicate higher levels of depression. 12 months
Primary Decrease in anxiety measured by PROMIS Short Form v1.0- Anxiety 4a. PROMIS Anxiety Bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Response options range from "Never" to "Always" with higher scores indicate higher levels of anxiety. 12 months
Primary Measure of trauma exposure using the Lifetime Events Checklist (LEC). The LEC measures trauma exposure, including the ability to differentiate direct experience vs work-related or other secondary exposure through a series of questions about stressful events, with responses including "happened to me," "witnessed it," "learned about it," "not sure," and "doesn't apply," followed up by a question asking if the experience happened as part of one's job. There is no formal scoring protocol or interpretation per se, other than identifying whether a person has experienced one or more of the events listed. 12 months
Primary Measure of PTSD symptoms using the the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Responses range from "not at all" to "extremely," with higher scores indicating higher occurrence of PTSD symptoms. 12 months
Primary Increase in meaning and purpose measured by PROMIS Short Form v1.0- Meaning and Purpose 4a. PROMIS Meaning and Purpose Bank assesses one's sense of life having purpose and that there are good reasons for living. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. 12 months
Primary Improvement in professional quality of life/well-being measured by Eudaimonic Workplace Well-being Scale (EWWS). EWWS measures workplace well-being on both interpersonal and intrapersonal dimensions through a series of eight statements where respondents indicate how strongly they relate to those statements. Values range from "strongly disagree" to "strongly agree," with higher scores reflecting higher workplace well-being/quality of life. 12 months
Secondary Decrease in staff turnover. Measured by number of READI staff who have left their job after <1 year of employment based on employee records 12 months
Secondary Increase in staff retention Measured by number of staff who have stayed employed for >1 year based on employee records 12 months
Secondary Increase in staff promotion Measured by number of staff who have been promoted into a new role based on employee records 12 months
Secondary Decrease in use of sick days Measured by average number of sick days used per staff member based on employee records 12 months
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