Trial Outcomes & Findings for Adaptation of SFA for HRW (NCT NCT07149155)

NCT ID: NCT07149155

Last Updated: 2025-10-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

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

Results posted on

2025-10-14

Participant Flow

Recruitment Period: September 24 2024 - October 1 2024 in harm reduction organization

Participant milestones

Participant milestones
Measure
Stress First Aid
Harm Reduction Workers received 2-hour in-person Stress First Aid (SFA) training and four, 30-minute learning collaboratives to reinforce SFA core components.
Overall Study
STARTED
35
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Stress First Aid
Harm Reduction Workers received 2-hour in-person Stress First Aid (SFA) training and four, 30-minute learning collaboratives to reinforce SFA core components.
Overall Study
Lost to Follow-up
10

Baseline Characteristics

Two participants did not complete a baseline assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stress First Aid
n=35 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Age, Continuous
47.52 Years
STANDARD_DEVIATION 10.93 • n=35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=35 Participants
Race (NIH/OMB)
Asian
0 Participants
n=35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=35 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=35 Participants
Race (NIH/OMB)
White
22 Participants
n=35 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=35 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=35 Participants
Sex/Gender, Customized
Female
22 Participants
n=35 Participants
Sex/Gender, Customized
Male
10 Participants
n=35 Participants
Sex/Gender, Customized
Unknown or Not Reported
3 Participants
n=35 Participants
Baseline Mean Knowledge of Stress First Aid (SFA)
3.15 Score on a Scale
STANDARD_DEVIATION 0.61 • n=33 Participants • Two participants did not complete a baseline assessment.
Baseline Mean Confidence in Stress First Aid (SFA)
3.06 Score on a Scale
STANDARD_DEVIATION 0.63 • n=33 Participants • Two participants did not complete a baseline assessment.
Baseline Mean Beliefs in Stress First Aid (SFA)
3.93 Score on a Scale
STANDARD_DEVIATION 0.58 • n=33 Participants • Two participants did not complete a baseline assessment.

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=25 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Knowledge of Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Knowledge Sub-Scale at 4 Months
4.01 Score on a Scale
Standard Deviation 0.54

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=25 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Confidence in Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Confidence Sub-Scale at 4 Months
3.90 Score on a Scale
Standard Deviation 0.56

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=25 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Beliefs in Stress First Aid (SFA) Assessed by Stress First Aid Knowledge, Confidence, and Beliefs - Beliefs Sub-Scale at 4 Months
4.26 Score on a Scale
Standard Deviation 0.41

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=30 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Acceptability of SFA Assessed by Acceptability of Intervention Measure (AIM)
4.40 Score on a Scale
Standard Deviation 0.79

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=30 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Appropriateness of SFA Assessed by Intervention Appropriateness Measure (IAM)
4.56 Score on a Scale
Standard Deviation 0.80

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Stress First Aid
n=30 Participants
Harm Reduction Workers received Stress First Aid training and learning collaboratives
Mean Feasibility of SFA Assessed by Feasibility of Intervention Measure (FIM)
4.45 Score on a Scale
Standard Deviation 0.58

Adverse Events

Stress First Aid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Coordinator

Dell Medical School, The University of Texas at Austin

Phone: NA

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place