NCT07177014

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Dec 2025Feb 2029

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

September 9, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

Stress First AidPersons who use drugsoverdose preventioncommunity outreach workerssubstance use outreach workers

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to 2 months after the intervention training

Study Arms (2)

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.

Behavioral: Stress First Aid (SFA)

Interventions

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.

Stress First Aid (SFA)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Study Officials

  • Creech

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Coordinator

CONTACT

Outreach Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized hybrid type I trial of SFA adapted for the substance use outreach workforce compared to a no treatment control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean of Strategic Research Initiatives and Department of Psychiatry and Behavioral Sciences Professor

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

December 5, 2025

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations