Mental Health Wellness 1NCT03801408
Building Partnerships With First Responders to Improve Delivery and Access of Mental Health Services
An observational study of Mental Health Wellness 1, run by University of Arkansas at 1 site in United States.
Trial summary
This study will conduct qualitative interviews with firefighters and EMTs/ paramedics across Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of firefighters and emergency medical technicians/paramedics from across Arkansas to participate in qualitative interviews, defined as focus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Wellness 1
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Firefighters and EMT/paramedics in Arkansas
Who may be able to join
- ages 18 and over volunteer and career personnel active, inactive, and retired
Who cannot join
- Non- English speaking (due to the nature of focus group/interview discussions)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Building Partnerships With First Responders to Explore Strategies to Improve Delivery and Access of Mental Health Services
This study will conduct qualitative interviews with firefighters and EMTs/ paramedics across Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of firefighters and emergency medical technicians/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. Through this work, this will generate the scientific foundation to develop a comprehensive, mental health service model that will motivate engagement in services by diverse first responders.
Read the detailed description
Firefighters and emergency medical technicians (EMTs)/ paramedics respond to more than 50 million emergency calls in the U.S. every year. The daily operations and experiences that are expected and accepted as part of their job expose them to various traumatic events. The nature, frequency, and intensity of duty-related traumatic exposures place these first responders (FRs) at significant risk for mental health (MH) problems, such as post-traumatic stress disorder (PTSD) and suicide. However, due to the stigma of mental illness and the culture of self-reliance and strength that surrounds FRs, few are willing to seek help. There will be a two-stage exploratory, qualitative study that will use a statewide community-engagement approach to conceptualize a MH service model that would motivate FRs to be more engaged in services. In Stage 1, qualitative interviews with firefighters and EMTs/ paramedics will be conducted across Arkansas. In Stage 2, product development process grounded in these findings to conceptualize a MH service model feasible for implementation in real world settings. (Protocol for Stage 2 will be submitted for IRB approval at a later time.) Stage 1, Specific Aim: Identify FRs' preferences and priorities regarding MH service and delivery methods, including the feasibility, acceptability, and value of each method. To address this aim, we will use opt-in methods to recruit a diverse group of firefighters and EMTs/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. After all qualitative interviews have been analyzed, a series of product development activities in Stage 2. Through this work, the scientific foundation to develop a comprehensive, MH service model that will motivate engagement in services by diverse FRs. This study's findings will guide a multi-stage, research agenda that will include development and pilot testing of the MH service model, ultimately, promoting engagement in MH services may decrease suicide rates and improve the overall MH outcomes among this at-risk population.
- Conditions
- Mental Health Wellness 1
What is being measured
The primary outcome is the main question the study is designed to answer.
First Responders Who Provided Qualitative Data
Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Mar 2019
- Primary completion25 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Jones, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801408
- Sponsor's protocol ID
- 228929
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2018
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Partnerships With First Responders to Explore Strategies to Improve Delivery and Access of Mental Health Services
- ClinicalTrials.gov ID
- NCT03801408
- Acronym / sponsor ID
- 228929
- Conditions
- Mental Health Wellness 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 16 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will conduct qualitative interviews with firefighters and EMTs/ paramedics across Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of firefighters and emergency medical technicians/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. Through this work, this will generate the scientific foundation to develop a comprehensive, mental health service model that will motivate engagement in services by diverse first responders.
Detailed description
Firefighters and emergency medical technicians (EMTs)/ paramedics respond to more than 50 million emergency calls in the U.S. every year. The daily operations and experiences that are expected and accepted as part of their job expose them to various traumatic events. The nature, frequency, and intensity of duty-related traumatic exposures place these first responders (FRs) at significant risk for mental health (MH) problems, such as post-traumatic stress disorder (PTSD) and suicide. However, due to the stigma of mental illness and the culture of self-reliance and strength that surrounds FRs, few are willing to seek help. There will be a two-stage exploratory, qualitative study that will use a statewide community-engagement approach to conceptualize a MH service model that would motivate FRs to be more engaged in services. In Stage 1, qualitative interviews with firefighters and EMTs/ paramedics will be conducted across Arkansas. In Stage 2, product development process grounded in these findings to conceptualize a MH service model feasible for implementation in real world settings. (Protocol for Stage 2 will be submitted for IRB approval at a later time.) Stage 1, Specific Aim: Identify FRs' preferences and priorities regarding MH service and delivery methods, including the feasibility, acceptability, and value of each method. To address this aim, we will use opt-in methods to recruit a diverse group of firefighters and EMTs/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. After all qualitative interviews have been analyzed, a series of product development activities in Stage 2. Through this work, the scientific foundation to develop a comprehensive, MH service model that will motivate engagement in services by diverse FRs. This study's findings will guide a multi-stage, research agenda that will include development and pilot testing of the MH service model, ultimately, promoting engagement in MH services may decrease suicide rates and improve the overall MH outcomes among this at-risk population.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Firefighters and EMT/paramedics in Arkansas
Key inclusion criteria (1 listed)
- ages 18 and over volunteer and career personnel active, inactive, and retired
Key exclusion criteria (1 listed)
- Non- English speaking (due to the nature of focus group/interview discussions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First Responders Who Provided Qualitative Data
Time frame: 1.5 year
Number of first responders who provided perspectives and/or priorities for mental health services and/or provided suggestions for how to adapt this feedback to the population.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sara Jones, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1, run by University of Arkansas at 1 site in United States.
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 1 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First Responders Who Provided Qualitative Data (time frame: 1.5 year). 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 16 Nov 2021.