Clinical trial NCT05931523: National Fallen Firefighter Foundation's (NFFF) Stress First Aid Intervention
Official title: Evaluation of the NFFF's Behavioral Health Stress First Aid Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: NDRI-USA, Inc.
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Ten fire departments from across the nation (8 career, 2 volunteer) were recruited for this study. In Aims 1 and 2, program evaluation methods were used to examine the implementation and acceptability of the SFAI intervention components. These evaluation methods were based on standard practices which employs a systematic method for collecting, analyzing, and using information to answer questions about the implementation and acceptability of the SFAI. In Aim 3 a pilot CRCT was conducted comparing the SFAI versus control (delayed treatment) on key behavioral health outcomes. Four career departments were randomized to the SFAI condition and 4 to the control condition. Statistical power analysis was based on these 8 career departments and will provide the primary project outcomes. Between groups outcomes were assessed at 12-months.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the SFA training by department personnel using a tailored satisfaction survey
timeFrame: Immediately after training components are delivered and 12 months later
Secondary outcomes:
Other outcomes:
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