Trial Outcomes & Findings for SAFE Workplace Intervention for People With IDD (NCT NCT06112249)
NCT ID: NCT06112249
Last Updated: 2026-01-28
Results Overview
The Infectious Airborne Disease Knowledge and Prevention of Behavior Outcomes is an assessment to see the knowledge of infectious airborne disease preventative behaviors gained through the SAFE curriculum. The assessment is completed through true and false questions, multiple choice questions, open ended questions, and behavior observations. Score: 1 - 67. Higher scores mean better outcomes.
COMPLETED
NA
67 participants
Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)
2026-01-28
Participant Flow
67 participants were recruited from 10 agencies that provide services to young adults with intellectual and developmental disabilities in and around the Philadelphia area. Recruitment and enrollment took place from 10/2023 thru 2/2024.
No pre-assignment issues were encountered.
Participant milestones
| Measure |
Control Group
Does not receive SAFE Curriculum
|
Peer Intervention
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
Receives SAFE Curriculum taught by staff.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
25
|
|
Overall Study
COMPLETED
|
20
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SAFE Workplace Intervention for People With IDD
Baseline characteristics by cohort
| Measure |
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 - 20 years
|
18 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
50 Participants
n=72 Participants
|
|
Age, Customized
21 - 26 years
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
|
Age, Customized
27 - 38 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
9 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Male
|
17 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
55 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Missing Response
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=41 Participants
|
20 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
57 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Asian and Pacific Islander
|
5 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Native American/Alaska Native
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
5 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
15 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
6 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
24 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Decline to answer
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Missing Response
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
|
Primary Disability
Intellectual Disability (ID)
|
5 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
|
Primary Disability
Autism Spectrum Disorder (ASD)
|
14 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
51 Participants
n=72 Participants
|
|
Primary Disability
Other Diagnosis
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Primary Disability
Decline to answer
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
|
Primary Disability
Missing Response
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Completed up to grade 11
|
8 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
17 Participants
n=72 Participants
|
|
Highest Level of Education Completed
High School Graduate or GED
|
10 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
39 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Some college, vocational, trade or business School
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
5 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Associates degree or vocational graduate
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Bachelors degree
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Some graduate of professional school training
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Highest Level of Education Completed
Graduate or professional degree
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
The Infectious Airborne Disease Knowledge and Prevention of Behavior Outcomes is an assessment to see the knowledge of infectious airborne disease preventative behaviors gained through the SAFE curriculum. The assessment is completed through true and false questions, multiple choice questions, open ended questions, and behavior observations. Score: 1 - 67. Higher scores mean better outcomes.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes
Pre Data (before intervention)
|
.71 score on a scale
Standard Deviation .15
|
.72 score on a scale
Standard Deviation .12
|
.61 score on a scale
Standard Deviation .17
|
|
Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes
Post 1 (immediately following)
|
.74 score on a scale
Standard Deviation .11
|
.84 score on a scale
Standard Deviation .07
|
.65 score on a scale
Standard Deviation .16
|
|
Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes
Post 2 (1 month after)
|
.75 score on a scale
Standard Deviation .13
|
.83 score on a scale
Standard Deviation .06
|
.66 score on a scale
Standard Deviation .17
|
|
Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes
Change from "Pre Data" at "Post 1"
|
0.04 score on a scale
Standard Deviation 0.22
|
0.03 score on a scale
Standard Deviation 0.12
|
0.11 score on a scale
Standard Deviation 0.12
|
|
Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes
Change from "Pre Data" at "Post 2"
|
0.04 score on a scale
Standard Deviation 0.22
|
0.03 score on a scale
Standard Deviation 0.12
|
0.11 score on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
This measure was adapted from employment-centered items on the Self-Determination and Self-Advocacy Questionnaire, which assess the degree of self-advocacy in the workplace as reported by staff and self-reported by participants. Score: 1 - 25. Higher scores mean better outcomes.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
Workplace Health and Safety Assessment
Post 2 (1 month after)
|
3.72 score on a scale
Standard Deviation .95
|
4.03 score on a scale
Standard Deviation .70
|
3.35 score on a scale
Standard Deviation 1.26
|
|
Workplace Health and Safety Assessment
Pre Data (before intervention)
|
2.99 score on a scale
Standard Deviation 1.14
|
3.74 score on a scale
Standard Deviation .84
|
3.68 score on a scale
Standard Deviation 1.08
|
|
Workplace Health and Safety Assessment
Post 1 (immediately following)
|
3.43 score on a scale
Standard Deviation 1.04
|
3.84 score on a scale
Standard Deviation .82
|
3.43 score on a scale
Standard Deviation 1.19
|
|
Workplace Health and Safety Assessment
Change from "Pre Data" at "Post 1"
|
0.45 score on a scale
Standard Deviation 1.10
|
0.10 score on a scale
Standard Deviation 0.74
|
-0.25 score on a scale
Standard Deviation 0.79
|
|
Workplace Health and Safety Assessment
Change from "Pre Data" to "Post 2"
|
0.79 score on a scale
Standard Deviation 1.21
|
0.31 score on a scale
Standard Deviation 0.76
|
-0.15 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
This measure assesses a person's belief in their capacity to manage daily stressors and have control over meaningful events. Participants will complete the 10-question tool which is designed for people 18 years and older. It has established acceptable reliability and validity.81 The responses are on a 5 point scale from "never" (1) to "very often" (5) with higher scores reflecting greater general self-efficacy. The scale (average across 10 questions) ranges from 1 to 5.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank
Pre Data (before intervention)
|
3.30 score on a scale
Standard Deviation .90
|
3.38 score on a scale
Standard Deviation .75
|
3.20 score on a scale
Standard Deviation .94
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank
Post 1 (immediately following)
|
3.21 score on a scale
Standard Deviation .85
|
3.39 score on a scale
Standard Deviation .77
|
3.26 score on a scale
Standard Deviation 1.03
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank
Post 2 (1 month after)
|
3.31 score on a scale
Standard Deviation .77
|
3.25 score on a scale
Standard Deviation .78
|
2.13 score on a scale
Standard Deviation 1.12
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank
Change from "Pre Data" at "Post 1"
|
-0.07 score on a scale
Standard Deviation 0.42
|
0.01 score on a scale
Standard Deviation 0.45
|
0.06 score on a scale
Standard Deviation 0.56
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank
Change from "Pre Data" to "Post 2"
|
0.03 score on a scale
Standard Deviation 0.58
|
-0.13 score on a scale
Standard Deviation 0.72
|
-0.07 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
The Vocfit is an assessment tool used to measure the best fit for a worker with a job. The tool was specifically developed for individuals with developmental disabilities and has strong psychometric properties for this population. Participants will complete the 10-question tool which is designed for people 18 years and older. The responses are on a 3 point scale from "Low = you can do it but you need someone else to help you the whole time" (0) to "High = you can do it by yourself" (2) with higher scores reflecting better fit for a worker with a job. The scale (average across 10 questions) ranges from 0 to 2.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
Vocational Fit Assessment Safety Subscale
Pre Data (before intervention)
|
1.06 score on a scale
Standard Deviation .45
|
1.21 score on a scale
Standard Deviation .36
|
1.00 score on a scale
Standard Deviation .5
|
|
Vocational Fit Assessment Safety Subscale
Post 1 (immediately following)
|
1.12 score on a scale
Standard Deviation .42
|
1.05 score on a scale
Standard Deviation .44
|
.90 score on a scale
Standard Deviation .52
|
|
Vocational Fit Assessment Safety Subscale
Post 2 (1 month after)
|
1.20 score on a scale
Standard Deviation .45
|
1.21 score on a scale
Standard Deviation .44
|
1.04 score on a scale
Standard Deviation .49
|
|
Vocational Fit Assessment Safety Subscale
Change from "Pre Data" at "Post 1"
|
0.06 score on a scale
Standard Deviation 0.43
|
-0.19 score on a scale
Standard Deviation 0.45
|
-0.12 score on a scale
Standard Deviation 0.39
|
|
Vocational Fit Assessment Safety Subscale
Change from "Pre Data" to "Post 2"
|
0.18 score on a scale
Standard Deviation 0.35
|
-0.03 score on a scale
Standard Deviation 0.35
|
0.05 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
This measure assesses "perceptions about the nature of events and their relationship to the values and perceived coping resources of an individual" for adults 18 years and older. This self-report measure has 10 items with a response range from "Never" (1) to "Very Often" (5). Higher scores reflect greater levels of perceived stress. The scale (average across 10 questions) ranges from 1 to 5.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).
Post 2 (1 month after)
|
2.93 score on a scale
Standard Deviation .49
|
3.04 score on a scale
Standard Deviation .59
|
2.66 score on a scale
Standard Deviation .45
|
|
National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).
Pre Data (before intervention)
|
2.98 score on a scale
Standard Deviation .41
|
3.11 score on a scale
Standard Deviation .54
|
2.87 score on a scale
Standard Deviation .37
|
|
National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).
Post 1 (immediately following)
|
2.95 score on a scale
Standard Deviation .45
|
2.90 score on a scale
Standard Deviation .58
|
2.71 score on a scale
Standard Deviation .45
|
|
National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).
Change from "Pre Data" at "Post 1"
|
-0.01 score on a scale
Standard Deviation 0.35
|
-0.20 score on a scale
Standard Deviation 0.47
|
-0.17 score on a scale
Standard Deviation 0.53
|
|
National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).
Change from "Pre Data" to "Post 2"
|
-0.04 score on a scale
Standard Deviation 0.38
|
-0.07 score on a scale
Standard Deviation 0.44
|
-0.22 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)Population: Intent to treat population (all participants assigned to "Control", "Peer Intervention", "Staff Delivered").
This measure assesses anxiety for adults 18 years and older. This self-report measure has 8 items with a response range from "Never" (1) to "Always" (5). Higher scores reflect greater levels of anxiety. It has established acceptable psychometrics and is sensitive to change. The scale (average across 8 questions) ranges from 1 to 5.
Outcome measures
| Measure |
Peer Intervention
n=22 Participants
Receives SAFE Curriculum taught by Peer Interventionist
|
Staff Delivered
n=25 Participants
Receives SAFE Curriculum taught by staff.
|
Control Group
n=20 Participants
Does not receive SAFE Curriculum
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.
Pre Data (before intervention)
|
18.86 score on a scale
Standard Deviation 7.51
|
20.82 score on a scale
Standard Deviation 6.82
|
18.25 score on a scale
Standard Deviation 6.45
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.
Post 1 (immediately following)
|
20.86 score on a scale
Standard Deviation 6.77
|
20.79 score on a scale
Standard Deviation 7.28
|
20.15 score on a scale
Standard Deviation 8.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.
Post 2 (1 month after)
|
20.70 score on a scale
Standard Deviation 7.49
|
21.21 score on a scale
Standard Deviation 5.68
|
17.25 score on a scale
Standard Deviation 7.30
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.
Change from "Pre Data" at "Post 1"
|
2.00 score on a scale
Standard Deviation 6.22
|
-0.13 score on a scale
Standard Deviation 5.57
|
1.90 score on a scale
Standard Deviation 8.52
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.
Change from "Pre Data" to "Post 2"
|
2.32 score on a scale
Standard Deviation 9.85
|
0.29 score on a scale
Standard Deviation 4.46
|
-1.00 score on a scale
Standard Deviation 5.70
|
Adverse Events
Control Group
Peer Intervention
Staff Delivered
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place