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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05931523
Other study ID # EMW-2014-FP-00945
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date October 2018

Study information

Verified date July 2023
Source NDRI-USA, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 659
Est. completion date October 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress First Aid
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
NDRI-USA, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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