Mental Health IssueNCT05931523
National Fallen Firefighter Foundation's (NFFF) Stress First Aid Intervention
A study testing Stress First Aid in people with Mental Health Issue, run by NDRI-USA, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Stress First Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Firefighters over the age of 18 willing to complete surveys
- Active in a department selected for the study
Who cannot join
- Those under the age of 18
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Stress First Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress First AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress First Aid | Experimental | Fire Departments received the Stress First Aid intervention trainings, tools, and resources. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the SFA training by department personnel using a tailored satisfaction survey
Percent of trainees who found the training useful and applicable
Measured: Immediately after training components are delivered and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study startJan 2016
- Primary completionAug 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- NDRI-USA, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Jahnke, NDRI-USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931523
- Sponsor's protocol ID
- EMW-2014-FP-00945
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can be requested from the study team
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the NFFF's Behavioral Health Stress First Aid Intervention
- ClinicalTrials.gov ID
- NCT05931523
- Acronym / sponsor ID
- EMW-2014-FP-00945
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- NDRI-USA, Inc.University, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress First Aid | Experimental | Behavioral: Stress First AidFire Departments received the Stress First Aid intervention trainings, tools, and resources. |
| Wait List Control | No intervention | –Fire Departments in this condition did not receive any intervention or training until the end of their observation year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Firefighters over the age of 18 willing to complete surveys
- Active in a department selected for the study
Key exclusion criteria (1 listed)
- Those under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress First AidThe 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. | Behavioural | Stress First Aid |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Yes. Can be requested from the study team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stress First Aid in people with Mental Health Issue, run by NDRI-USA, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.