- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931523
National Fallen Firefighter Foundation's (NFFF) Stress First Aid Intervention
Evaluation of the NFFF's Behavioral Health Stress First Aid Intervention
Purpose & Aims: Behavioral health interventions implemented to mitigate negative outcomes linked to trauma in the fire service have had limited or iatrogenic effects on firefighters. The National Fallen Firefighters Foundation (NFFF) and the national fire service community have invested considerable resources developing a new behavioral health model to address exposure to traumatic events. The proposed randomized controlled trial will be the first to determine the efficacy of the NFFF's Consensus Protocol on Firefighter Behavioral Health Stress First Aid Intervention (SFAI), as well as evaluating its implementation and acceptability.
Relevance: The SFAI was the result of one of the 16 Firefighter Life Safety Initiatives developed in consultation with the leading fire service organizations in the United States and experts from the traumatic stress research community. Failing to effectively address grief and trauma incidents or symptoms can have devastating effects for firefighters, fire departments, and families. The SFAI was developed to be the national model of trauma intervention to ensure that evidence-based cost-effective care is available to all firefighters.
Methods: Using a cluster randomized clinical trial design (CRCT), experienced scientists and fire service personnel will evaluate the implementation, acceptability, and initial efficacy of the SFAI compared with usual care (i.e., delayed intervention) with 10 fire departments (8 Career, 2 Volunteer) located across the country. Study outcomes include measures assessing implementation of SFAI components, acceptability among firefighters and department leadership, changes in knowledge about and self-efficacy for managing trauma, changes in department morale, and individual firefighter behavioral health outcomes such as symptoms of PTSD and personal growth through coping with traumatic events.
Projected Results & Conclusions: Findings will provide the empirical basis for the newly developed SFAI.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Firefighters over the age of 18 willing to complete surveys
- Active in a department selected for the study
Exclusion Criteria:
- Those under the age of 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stress First Aid
Fire Departments received the Stress First Aid intervention trainings, tools, and resources.
|
The focus of the model is ongoing monitoring of stress in personnel, wide spread training to help personnel recognize peers or subordinates who may need additional assistance, a spectrum of one-on-one interventions, and the ability to provide personnel higher levels of care when indicated.
|
No Intervention: Wait List Control
Fire Departments in this condition did not receive any intervention or training until the end of their observation year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the SFA training by department personnel using a tailored satisfaction survey
Time Frame: Immediately after training components are delivered and 12 months later
|
Percent of trainees who found the training useful and applicable
|
Immediately after training components are delivered and 12 months later
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EMW-2014-FP-00945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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