NCT05931523

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
659

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

March 3, 2023

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the SFA training by department personnel using a tailored satisfaction survey

    Percent of trainees who found the training useful and applicable

    Immediately after training components are delivered and 12 months later

Study Arms (2)

Stress First Aid

EXPERIMENTAL

Fire Departments received the Stress First Aid intervention trainings, tools, and resources.

Behavioral: Stress First Aid

Wait List Control

NO INTERVENTION

Fire Departments in this condition did not receive any intervention or training until the end of their observation year.

Interventions

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.

Stress First Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Firefighters over the age of 18 willing to complete surveys
  • Active in a department selected for the study

You may not qualify if:

  • Those under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

March 3, 2023

First Posted

July 5, 2023

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Can be requested from the study team

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
up to 5 years
Access Criteria
Request from research team