NCT07149155

Brief Summary

The aim of this study is to pilot and test the feasibility, acceptability, and effectiveness of a Stress First Aid (SFA) intervention adapted for Harm Reduction Workers (HRWs) serving Persons Who Use Drugs. The intervention consists of a training and learning collaboratives used to reinforce the SFA principles

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 14, 2025

Completed
Last Updated

October 14, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 18, 2025

Results QC Date

September 3, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

Stress First AidHarm Reduction WorkersPersons who use drugsoverdose preventioncommunity outreach workerspeer workers

Outcome Measures

Primary Outcomes (6)

  • Mean Knowledge of Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Knowledge Sub-Scale at 4 Months

    A 3-item, 5-point Likert type sub-scale of Stress First Knowledge, Confidence, and Beliefs Scale, developed by the developers of Stress First Aid (SFA), with a minimum score 1 "Does not describe me at all", maximum score 5 "Describes me very well", where a higher score is a better outcome.

    Assessed from enrollment to the end of the intervention at 4 months, 4 months reported

  • Mean Confidence in Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Confidence Sub-Scale at 4 Months

    A 6-item, 5-point Likert type sub-scale of Stress First Knowledge, Confidence, and Beliefs Scale, developed by the developers of Stress First Aid (SFA), with a minimum score 1 "Does not describe me at all", maximum score 5 "Describes me very well", where a higher score is a better outcome.

    Assessed from enrollment to the end of the intervention at 4 months, 4 months reported

  • Mean Beliefs in Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Beliefs Sub-Scale at 4 Months

    A 5-item, 5-point Likert type sub-scale of Stress First Knowledge, Confidence, and Beliefs Scale, developed by the developers of Stress First Aid (SFA), with a minimum score 1 "Does not describe me at all", maximum score 5 "Describes me very well", where a higher score is a better outcome.

    Assessed from enrollment to the end of the intervention at 4 months, 4 months reported

  • Mean Acceptability of SFA Assessed by Acceptability of Intervention Measure (AIM)

    A 4-item, 5-point Likert-type scale from Weiner et al., 2017, with a minimum score 1 "Completely disagree", maximum score 5 "Completely agree", where a higher score is a better outcome.

    Immediately after the 2-hour, in-person training.

  • Mean Appropriateness of SFA Assessed by Intervention Appropriateness Measure (IAM)

    A 4-item, 5-point Likert-type scale from Weiner et al., 2017, with a minimum score 1 "Completely disagree", maximum score 5 "Completely agree", where a higher score is a better outcome.

    Immediately after the 2-hour, in-person training.

  • Mean Feasibility of SFA Assessed by Feasibility of Intervention Measure (FIM)

    A 4-item, 5-point Likert-type scale from Weiner et al., 2017, with a minimum score 1 "Completely disagree", maximum score 5 "Completely agree", where a higher score is a better outcome.

    Immediately after the 2-hour, in-person training.

Study Arms (1)

Stress First Aid

EXPERIMENTAL

Harm Reduction Workers received Stress First Aid training and learning collaboratives

Behavioral: Stress First Aid for Harm Reduction Workers

Interventions

The intervention was a 2-hour, in-person SFA/HRW training followed by 30-minute monthly learning collaboratives to address occupational stress of harm reduction workers.

Also known as: SFA/HRW
Stress First Aid

Eligibility Criteria

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

You may qualify if:

  • Legal age of majority (18 +),
  • Ability to read and speak conversational English, and
  • Work as an HRW in substance misuse.

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

Location

Results Point of Contact

Title
Project Coordinator
Organization
Dell Medical School, The University of Texas at Austin

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot test
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 29, 2025

Study Start

September 24, 2024

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

October 14, 2025

Results First Posted

October 14, 2025

Record last verified: 2025-08

Locations