Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05931523
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-03-03
Brief Title:
National Fallen Firefighter Foundations NFFF Stress First Aid Intervention
Sponsor:
NDRI-USA Inc
Organization:
NDRI-USA Inc
Study Overview
Official Title:
Evaluation of the NFFFs Behavioral Health Stress First Aid Intervention
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NFFFs 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None