Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:17 AM
Study NCT ID:
NCT07478250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Responder Safety Training (FiRST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005390', 'term': 'Fires'}], 'ancestors': [{'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Promoting Lifestyles Profile II (HPLPII)', 'timeFrame': 'Baseline, 1,3,6,9,12 months', 'description': 'The HPLPII is a 52 item self-report inventory of health behaviors and has been used in?previous resilience building intervention studies. Participants rate the frequency of participation?in each item (never, sometimes, often or routinely). The scale yields a healthy lifestyle behaviors total score and 6 subscale scores: spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management. The total healthy lifestyle behaviors score will be used as the primary outcome.'}, {'measure': 'Post-traumatic Stress Disorder Checklist-5 (PCL-5)', 'timeFrame': 'Baseline, 1,3,6,9,12 months', 'description': 'The PCL-5 is a 20-item self-report measure of current PTSD symptoms based on the DSM-5 criteria. The PCL is a widely-used and validated measure of PTSD symptom severity. Participants are asked to rate problems they were bothered by in the past month on a scale of 1=not at all to 5=extremely. We will utilize the PCL-5 total score as a primary PTSD outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Trauma', 'Resilience', 'first responders'], 'conditions': ['Resilience and Mental Health of First Responders']}, 'descriptionModule': {'briefSummary': 'As a result of chronic exposures to traumatic and stressful events, first responders are at elevated risk for experiencing post-traumatic stress disorder (PTSD) and other mental health problems. Resilience training can reduce the risk for developing mental health symptoms in first responders. The National Institute for Environmental Health Sciences and the Substance Abuse Mental Health Services Administration developed the Worker Resilience Training (WRT) program - a 4-hour interactive workshop to educate responders on the effects of traumatic exposures, PTSD and ways to increase adaptive coping resources and promote resilience. We completed a randomized clinical trial (RCT) of the WRT for active responders (n = 167). Results indicated that the WRT, as compared to a waitlist control group, helped prevent the development of PTSD and depression symptoms, and improved important resilience indicators (i.e., healthy lifestyle behaviors, stress management, physical activity) over the course of three months. The proposed multi-site RCT seeks to build on our initial study by conducting a Stage III efficacy trial of the WRT workshop in N=800 first responders in New York (NY) and Texas (TX). Our specific aims are: Aim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year. Aim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop. Aim 3. To identify the target treatment mechanisms of the WRT for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop. Aim 4. To gather qualitative data to further inform a future effectiveness trial including perceptions about the use and potential impact of peer leaders delivering the program content, and perceptions about mode of program delivery via open-ended questions at follow-up. We will use a cluster RCT design and multi-modal assessments including self-report measures, a web-based stress reactivity performance task, and real-time accelerometry. Participants in both conditions will also receive a booster session at 3 months post workshop to reinforce skills and intervention knowledge. This study will contribute to our understanding of how resilience training may serve to protect the mental health and functioning of first responders. This study has important clinical and public health implications, including preserving/strengthening mental health and reducing overall personal and financial costs. This study also takes a research to practice approach by working collaboratively with fire departments and EMS organizations in NY and TX. If successful, we will work with these leaders to develop a method for annual WRT trainings to foster resilience and promote well-being long-term for first responders.', 'detailedDescription': "This study seeks to build on our initial study by conducting a Stage III efficacy trial of the Worker Resilience Training (WRT) workshop and monitoring outcomes over the course of one year in N=800 first responders in NY and TX. Specifically, we will employ a stratified parallel group cluster randomized clinical trial (RCT) design to evaluate the efficacy of the WRT (intervention) compared to a Fire and Medical Safety (FAMS) workshop (time-matched control) for (1) engaging resilience targets (i.e., promoting healthy behaviors, stress management and physical activity), increasing perceived resilience and preventing deterioration in mental and occupational health and functioning in first responders; and (2) to evaluate mediators of the effect of the WRT program on mental and occupational health and functioning. Participants in both conditions will also receive a booster session at 3 months post workshop. Multi-modal assessments will be used including self-report measures, daily diary survey of skills practice, a web-based stress reactivity performance task, and real-time accelerometry.\n\nOur specific aims are:\n\nAim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year.\n\nAim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop.\n\nAim 3. To identify the target treatment mechanisms of the WRT (i.e., healthy lifestyle behaviors, stress management, physical activity and perceived resilience) for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop.\n\nAim 4. To gather qualitative data to further inform a future effectiveness trial including perceptions about the use and potential impact of peer leaders delivering the program content, and perceptions about mode of program delivery via open-ended questions at follow-up.\n\nOverview of study design: A stratified parallel group cluster RCT is proposed to evaluate the efficacy of the WRT workshop (intervention) compared to a Fire and Medical Safety (FAMS) workshop (time-matched control) on perceived resilience, resilience targets, mental and occupational health outcomes and functioning over a one year period among first responders. The trial will be stratified by region TX and NY. The cluster unit will be the first responder organization (fire stations, private companies, hospitals, etc.) and the analysis unit will be the first responder. A cluster RCT is proposed to (1) represent the organizational structure of the occupations and therefore, account for variation between clusters and (2) reduce potential contamination within responder organizations. We chose not to randomize individual responders into WRT or FAMS training because employees from the same organization in different arms may talk to each other about their experience with the workshop, contributing to contamination. We propose a clustered RCT design to safeguard against contamination to the greatest extent possible. Additional steps will be taken to not identify the interventions as experimental or control. All study assessments will be web-based, and investigators or staff thus will have limited contact with participants outside of scheduled workshops and reminders for assessments. To address potential participant cross talk and cross contamination of intervention conditions, we will (a) include questions at each follow-up to inquire whether participants discussed the study or intervention with co-workers outside of their fire station and (b) plan to account for these data in analyses (e.g., Please rate the extent to which you discussed the study with co-workers outside of your fire station on a 1-7 Likert style scale).\n\nStudy Sample: We expect to recruit 40 firefighter or EMS organizations with 20 responders per organization, in total 800 first responders. Half of the sample (N=400) will be recruited from NY from various EMS organizations and local fire departments, and half (N=400) from TX from the Houston Fire Department (HFD). We chose to enroll both EMS workers and firefighters as many are cross-trained for both positions (e.g., all Houston firefighters are also EMS workers). The HFD is the third largest fire department in the U.S. The HFD consists of over 4300 firefighters (all also trained as EMS workers) ages 18 to 64 across 105 fire stations. Long Island's firefighter population is composed of 179 municipal volunteer fire stations across Nassau and Suffolk counties.\n\nInclusion criteria include age greater than 18 and being an active member of the fire stations or EMS organizations that we engage for participation. All participants will be English speaking, which is a requirement of the occupation. In an effort to evaluate the efficacy of the WRT outside of the lab in real world settings, we have not limited the sample with any exclusion criteria. Instead, we will assess and control for various factors that could affect our findings including engagement current (past month, assessed at baseline and follow-ups) mental health treatment (psychotherapy and/or use of psychotropic medications), current suicide ideation or history of attempts, mental health symptoms at baseline, and presence of physical health conditions. In addition, given the randomized design, we expect that these factors will be similarly distributed across both conditions.\n\nProcedure: The research coordinators will reach out to various first responder organizations in NY and TX to discuss the purpose of the study and to engage leadership who have already expressed support and collaboration for this project. In addition, Dr. Moline will utilize her contacts within the first responder community to also engage leaders of organizations as needed. Coordinators at each site will use SMART software, a clinical trial management system, to track recruitment and retention of organizations and responders within organizations. After receiving approval from leadership, flyers and information about the study will be distributed to the organization to recruit individual responders. In addition, we will work with leadership to send out an email to all responders alerting them about the study with a link for them to click to access our study's consent form. A workshop date will be set approximately one month after recruitment is initiated. Interested responders can either click the link in recruitment email or call the research lab and the coordinator will provide information about the study including emailing the participant the link to a secure web-based application, Research Data Capture application (REDCap). Based on previous experience and recent survey, the majority of responders in these communities have internet access. Participants will be immediately directed to an online consent form (in REDCap) to review and acknowledge their agreement to participate in the study. If they positively endorse the consent form, they will be directed to complete the baseline assessment questionnaires and the web-based stress reactivity task. Trigger alerts in REDCap will be set to automatically alert the research coordinator if a participant endorses suicidality on the depression symptoms assessment. The PI will be alerted by the coordinator and the participant will be called for follow-up safety assessment and provided mental health treatment referrals as needed. Screening and recruitment logs detailing participant interest, eligibility will be completed and maintained by the study coordinator using SMART software. Recruitment data will be monitored closely at weekly meetings within and across study sites.\n\nAfter 20 first responders within an organization (e.g., fire station) have consented to the study, the organization will then be randomized using the randomization schema outlined below. The coordinator will re-contact all participants from the organization once they complete the full baseline assessment and are randomized to a workshop condition. The coordinator will schedule participation in the WRT or FAMS workshop, will email the participant with instructions for attending the workshop meeting and will mail the participant a Fitbit device with instructions on how to download the Fitbit app. Fitbit data will be continuously uploaded to individual accounts set up by the research team. All participants will be given a unique identification number to protect confidentiality. Workshops will take place at the responder organization or at a University conference room. We are also prepared to deliver the workshops remotely via Zoom. Workshop leaders in TX and NY will be trained by Dr. Gonzalez for administering the WRT and Dr. Leah Saulter (HFD psychologist) for administering the FAMS. All workshops will be audio-recorded for fidelity checks. Participants will complete a REDCap survey immediately post workshop to assess participant satisfaction with the training and feedback as noted below. At 1, 3, 6, 9, 12-months post-workshop, the study coordinator will call participants and email a link to REDCap to complete the follow-up assessments (identical to baseline assessment). After the 3-month follow-up assessment, participants in both conditions will complete a booster session at the responder organization or a University conference room.\n\nRandomization. A randomization schema will be generated by the Biostatistics Unit at Feinstein/Northwell for each region (NY or TX) using the method of permuted blocks by a separate statistician from the study team. Clusters (responder organization) will be randomly assigned in a 1 to 1 ratio to either WRT or FAMS group, stratified by region (TX or NY) after they have met enrollment of at least 20 responders. Randomization will provide each organization within a region an equal chance of being assigned to WRT or FAMS group. The randomization will be pre-generated and programmed into the Biostatistics Randomization Management System (BRMS). After a project coordinator from a region determines cluster enrollment, the coordinator will access the BRMS system and provide the parameters, (study ID number, region, organization ID) to the system. Then BRMS software will inform the coordinator of a unique randomization sequence ID number and randomization assignment (WRT or FAMS) for that organization. Randomization sequence numbers will be generated to reflect region and organization enrollment. A randomization confirmation email, which contains all relevant information such as organization identification, randomization sequence number, stratification value, and intervention assignment will be automatically sent to the coordinator.\n\nBlinding: The organizations and first responders cannot truly be blinded to the workshop assignment (WRT or FAMS), however, steps will be taken to not identify the WRT as the experimental workshop. Specifically, organizational leaders and responders will be told that we are evaluating two health and safety training workshops and they have an equal chance of receiving either workshop. To address potential participant cross talk and cross-contamination of intervention conditions, we will a. include questions at each follow-up to inquire whether participants discussed the study or intervention with coworkers outside of their fire station and b. plan to account for these data in analyses (e.g., Please rate the extent to which you discussed the study with co-workers outside of your fire station on a 1-7 Likert-style scale).\n\nCompliance: Compliance is defined as staying for the entire 4-hour workshop (WRT or FAMS) and attending the 3- month booster session.\n\nStudy Interventions: Organizations will be randomized to complete either the WRT or FAMS (control) workshop. At this time, we are planning for the workshop to take place in-person. We are also prepared to deliver the workshops remotely via Zoom. Stony Brook University maintains a Zoom business agreement for the organization. Individual break-out rooms would be utilized within Zoom to allow for small group activities and discussions. The WRT and FAMS workshops will be delivered by trainers trained and supervised by Dr. Gonzalez and Dr. Saulter (respectively).\n\nQuantitative and qualitative assessments will be conducted to measure main study variables and to acquire participant feedback about the WRT workshop. All quantitative data will be entered directly into REDCap by the participant. Program acceptability and perceived utility will be assessed at the end of the workshop via a brief workshop satisfaction form with open-ended questions completed via REDCap. These qualitative data will be entered into MaxQDA for thematic content analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Active first responder at fire station or EMS organization\n\n\\-\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT07478250', 'acronym': 'FiRST', 'briefTitle': 'First Responder Safety Training (FiRST)', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'A Large-scale Efficacy Trial of a Resilience Training Program for First Responders', 'orgStudyIdInfo': {'id': 'R01MH137282', 'link': 'https://reporter.nih.gov/quickSearch/R01MH137282', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH137282', 'link': 'https://reporter.nih.gov/quickSearch/R01MH137282', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Worker Resilience Training Program', 'description': 'The WRT is a 4-hour workshop to aid in building resilience and preventing the development of mental health problems among first responders and other workers frequently exposed to trauma. The WRT includes empirically supported psychological techniques such as motivational interviewing, health behavior goal setting, stress management skills and relaxation training. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.', 'interventionNames': ['Behavioral: Worker Resilience Training Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fire and Medical Safety (FAMS)', 'description': 'The 4-hour FAMS program consists of a review of standard fire and emergency medical health and safety guidelines, skills, and procedures common across fire and EMS departments nationally. The FAMS program will cover topics that are typically presented to fire and EMS providers annually for continuing education or recertification purposes. The FAMS program will adapt content relevant to fire and EMS health and safety operations, fire suppression and safety, gear operation and maintenance, as well as patient medical assessment and care. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.', 'interventionNames': ['Behavioral: Fire and Medical Safety (FAMS)']}], 'interventions': [{'name': 'Worker Resilience Training Program', 'type': 'BEHAVIORAL', 'description': 'The WRT is a 4-hour workshop to aid in building resilience and preventing the development of mental health problems among first responders and other workers frequently exposed to trauma. The WRT includes empirically supported psychological techniques such as motivational interviewing, health behavior goal setting, stress management skills and relaxation training. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.', 'armGroupLabels': ['Worker Resilience Training Program']}, {'name': 'Fire and Medical Safety (FAMS)', 'type': 'BEHAVIORAL', 'description': 'The 4-hour FAMS program consists of a review of standard fire and emergency medical health and safety guidelines, skills, and procedures common across fire and EMS departments nationally. The FAMS program will cover topics that are typically presented to fire and EMS providers annually for continuing education or recertification purposes. The FAMS program will adapt content relevant to fire and EMS health and safety operations, fire suppression and safety, gear operation and maintenance, as well as patient medical assessment and care. A booster session for a review of training materials and additional support will be conducted following the 3-month follow-up assessment.', 'armGroupLabels': ['Fire and Medical Safety (FAMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Adam Gonzalez', 'role': 'CONTACT', 'email': 'adam.gonzalez@stonybrook.edu', 'phone': '631-632-8657'}, {'name': 'Adam Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '77840', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Anka Vujanovic, PhD', 'role': 'CONTACT', 'email': 'avujanovic@tamu.edu', 'phone': '979-862-6538'}, {'role': 'CONTACT', 'email': 'avujanovic@tamu.edu', 'phone': '979-862-6538'}, {'name': 'Anka Vujanovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas A & M University', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}], 'centralContacts': [{'name': 'Adam Gonzalez', 'role': 'CONTACT', 'email': 'adam.gonzalez@stonybrook.edu', 'phone': '631-632-8657'}], 'overallOfficials': [{'name': 'Adam Gonzalez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Data will be shared via the NIMH data repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Texas A&M University', 'class': 'OTHER'}, {'name': 'Feinstein Institute for Medical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Adam Gonzalez', 'investigatorAffiliation': 'Stony Brook University'}}}}