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Recruiting NCT07177014

Impact of Stress First Aid for Workers in Substance Misuse Settings

No phase Interventional Occupational Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stress First Aid (SFA).
Who it may be relevant to
Registry conditions: Occupational Health. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

\- Inability to provide consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas at Austin — Austin

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. PMID 42323672

Identifiers

NCT: NCT07177014 · STUDY00008024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗