Occupational HealthSFA-ImpactNCT07177014
Impact of Stress First Aid for Workers in Substance Misuse Settings
A study testing Stress First Aid (SFA) in people with Occupational Health, run by University of Texas at Austin at 1 site in United States.
Trial summary
Test the effectiveness of SFA adapted for the substance use outreach workforce compared to a no treatment control condition on social-support and burnout of HRWs in a cluster-randomized hybrid type I trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Occupational Health
- What is being tested?
- Stress First Aid (SFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- In a paid or volunteer role as a substance use outreach worker or community health/outreach worker (whose work includes substance use outreach) with people who use drugs within TX, LA, AR, OK, NM and tribal areas
- Able and willing to provide informed consent
Who cannot join
- Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Outreach Coordinator contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
About this study
Test the effectiveness of SFA adapted for the substance use outreach workforce compared to a no treatment control condition on social-support and burnout of HRWs in a cluster-randomized hybrid type I trial.
Read the detailed description
Alongside prevention, treatment, and supply reduction, outreach work is a cornerstone of the National Drug Control Strategy. However, there is a critical gap in research on the occupational health of substance use outreach workers, who are exposed to high rates of lifetime and occupational stress and trauma. High rates of unaddressed occupational stress have been shown to have an adverse impact on patient care and are linked to unmet mental health needs, turnover, burnout, and relapse. The substance use outreach workforce needs an occupational stress intervention program that addresses both systems and individual occupational challenges while promoting the capacity to engage with the complex demands of delivering safe high-quality substance use care to people who use drugs (PWUD).
Stress First Aid is a promising intervention that has been implemented with several first responder groups and in healthcare settings, but it requires adaptation to the substance use outreach workforce and it needs to be studied against a control group in a rigorous clinical trial. In the R61 planning phase of this study, focus groups comprised of workers and leaders from organizations doing substance use outreach work were convened to adapt the SFA training content and to inform the SFA training delivery methods that were piloted in a field test (N = 35). Findings were integrated into a clinical trial protocol.
In the R33 phase of this study, we will conduct a cluster-randomized hybrid type I trial (N = 500) testing the effectiveness of participation in a 2-hour virtual SFA training and six 30-minute monthly learning collaboratives compared to a no treatment control condition on the following primary outcomes: supervisor and coworker support and burnout. Secondary outcomes are use of SFA concepts, job related affective well-being, secondary traumatic stress, coping strategies, self-efficacy, work engagement, turnover intention, and moral injury symptoms. The long-term goal of our work is to implement a sustainable and effective occupational stress intervention for the substance use outreach workforce nationally in order to strengthen their important role in the substance misuse work force.
- Conditions
- Occupational Health
- Being tested
- Stress First Aid (SFA)
- Keywords
- Stress First Aid, Persons who use drugs, overdose prevention, community outreach workers, substance use outreach workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress First Aid (SFA)Behavioural
Stress First Aid for the Substance Use Outreach Workforce is a 2-hour training and up to six virtual 30-minute monthly learning collaborative meetings.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | No intervention | Control: No Treatment |
| Stress First Aid (SFA) | Experimental | Treatment group receives Stress First Aid for the Substance Use Outreach Workforce, a 2-hour training and up to six virtual 30-minute monthly learning collaborative meetings. Receives: Behavioral: Stress First Aid (SFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean Overall Burnout Assessed by the Copenhagen Burnout Inventory at 2 Months
A 19-item, 5-point Likert type scale, where a higher score is a worse outcome. Minimum score of 0, maximum score of 100.
Measured: From enrollment to 2 months after the intervention training
Change from Baseline in the Mean Overall Social Support Assessed by the Job Content Questionnaire Social Support Sub-Scale at 2 Months
An 8-item; 4-point Likert-type scale, where a higher score is a better outcome. Minimum score of 8, maximum score of 40.
Measured: From enrollment to 2 months after the intervention training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start5 Dec 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational HealthStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized hybrid type I trial of SFA adapted for the substance use outreach workforce compared to a no treatment control condition.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Suzannah Creech, University of Texas at Austin
- Investigators
- Creech, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177014
- Sponsor's protocol ID
- STUDY00008024
- Acronym
- SFA-Impact
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desai A, McCormick KA, Rau J, Rochani H, Chang P, Westphal RJ, Watson PJ, Claborn KR, Benzer JK, Creech SK. Impact and implementation evaluation of Stress First Aid for the Substance Use Outreach Workforce (SFA/SUOW): protocol of a hybrid type I cluster randomized control trial. Trials. 2026 Jun 20. doi: 10.1186/s13063-026-09856-4. Online ahead of print.
PubMed 42323672
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stress First Aid for Workers in Substance Misuse Settings
- ClinicalTrials.gov ID
- NCT07177014
- Acronym / sponsor ID
- SFA-Impact / STUDY00008024
- Conditions
- Occupational Health
- Keywords
- Stress First Aid, Persons who use drugs, overdose prevention, community outreach workers, substance use outreach workers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 16 Sep 2025 (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.
Test the effectiveness of SFA adapted for the substance use outreach workforce compared to a no treatment control condition on social-support and burnout of HRWs in a cluster-randomized hybrid type I trial.
Detailed description
Alongside prevention, treatment, and supply reduction, outreach work is a cornerstone of the National Drug Control Strategy. However, there is a critical gap in research on the occupational health of substance use outreach workers, who are exposed to high rates of lifetime and occupational stress and trauma. High rates of unaddressed occupational stress have been shown to have an adverse impact on patient care and are linked to unmet mental health needs, turnover, burnout, and relapse. The substance use outreach workforce needs an occupational stress intervention program that addresses both systems and individual occupational challenges while promoting the capacity to engage with the complex demands of delivering safe high-quality substance use care to people who use drugs (PWUD).
Stress First Aid is a promising intervention that has been implemented with several first responder groups and in healthcare settings, but it requires adaptation to the substance use outreach workforce and it needs to be studied against a control group in a rigorous clinical trial. In the R61 planning phase of this study, focus groups comprised of workers and leaders from organizations doing substance use outreach work were convened to adapt the SFA training content and to inform the SFA training delivery methods that were piloted in a field test (N = 35). Findings were integrated into a clinical trial protocol.
In the R33 phase of this study, we will conduct a cluster-randomized hybrid type I trial (N = 500) testing the effectiveness of participation in a 2-hour virtual SFA training and six 30-minute monthly learning collaboratives compared to a no treatment control condition on the following primary outcomes: supervisor and coworker support and burnout. Secondary outcomes are use of SFA concepts, job related affective well-being, secondary traumatic stress, coping strategies, self-efficacy, work engagement, turnover intention, and moral injury symptoms. The long-term goal of our work is to implement a sustainable and effective occupational stress intervention for the substance use outreach workforce nationally in order to strengthen their important role in the substance misuse work force.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized hybrid type I trial of SFA adapted for the substance use outreach workforce compared to a no treatment control condition.
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –Control: No Treatment |
| Stress First Aid (SFA) | Experimental | Behavioral: Stress First Aid (SFA)Treatment group receives Stress First Aid for the Substance Use Outreach Workforce, a 2-hour training and up to six virtual 30-minute monthly learning collaborative meetings. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- In a paid or volunteer role as a substance use outreach worker or community health/outreach worker (whose work includes substance use outreach) with people who use drugs within TX, LA, AR, OK, NM and tribal areas
- Able and willing to provide informed consent
Key exclusion criteria (1 listed)
- Inability to provide consent
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 Aid (SFA)Stress First Aid for the Substance Use Outreach Workforce is a 2-hour training and up to six virtual 30-minute monthly learning collaborative meetings. | Behavioural | Stress First Aid (SFA) |
Primary outcome
Change from Baseline in the Mean Overall Burnout Assessed by the Copenhagen Burnout Inventory at 2 Months
Time frame: From enrollment to 2 months after the intervention training
A 19-item, 5-point Likert type scale, where a higher score is a worse outcome. Minimum score of 0, maximum score of 100.
Change from Baseline in the Mean Overall Social Support Assessed by the Job Content Questionnaire Social Support Sub-Scale at 2 Months
Time frame: From enrollment to 2 months after the intervention training
An 8-item; 4-point Likert-type scale, where a higher score is a better outcome. Minimum score of 8, maximum score of 40.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Derived from this study: PubMed 42323672Desai A, McCormick KA, Rau J, Rochani H, Chang P, Westphal RJ, Watson PJ, Claborn KR, Benzer JK, Creech SK. Impact and implementation evaluation of Stress First Aid for the Substance Use Outreach Workforce (SFA/SUOW): protocol of a hybrid type I cluster randomized control trial. Trials. 2026 Jun 20. doi: 10.1186/s13063-026-09856-4. Online ahead of print.
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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.
Outreach Coordinator contact
Creech principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress First Aid (SFA) in people with Occupational Health, run by University of Texas at Austin 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 3 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Coordinator (512-495-5277, SFA@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean Overall Burnout Assessed by the Copenhagen Burnout Inventory at 2 Months (time frame: From enrollment to 2 months after the intervention training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07177014, which also lists 1 linked publication.
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 3 Mar 2026.