Trial Outcomes & Findings for Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use (NCT NCT06410287)
NCT ID: NCT06410287
Last Updated: 2026-03-11
Results Overview
Negative or stigmatizing attitudes and/or beliefs registered nurses have towards perinatal substance use; measured using the Modified Attitudes About Drug Use in Pregnancy Scale. Total scores range between 1 and 5, with scores closer to 1 associated with a more positive outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline (Phase 1a); immediately post intervention (Site 1) or 7-30 days post baseline (Site 2) (Phase 1b); immediately post (Site 2) or 30 days post intervention (Site 1) (Phase 2); 30 days post (Site 2) or 60 days post intervention (Site 1) (Phase 3)
Results posted on
2026-03-11
Participant Flow
Participants were recruited from two hospitals in July 2024. The study aimed to recruit up to 75 participants from each hospital.
Participant milestones
| Measure |
Site 1 Phases 1 and 2
Participants from the hospital randomized to the experimental group will be first to receive an invitation to complete the web-based educational program. The program will be open for one month. Thirty days after a participant completes the program, they will be sent a link to a follow up survey (web-based).
|
Site 1 Phase 3: Follow-up Survey
At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey.
|
Site 1 Phase 3: 1:1 Interview
At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey and participate in a 1:1 interview.
|
Site 2
Participants from the hospital randomized to the control setting will receive an invitation to complete a survey that collects baseline data for the outcome (stigma toward perinatal substance use) and demographic information. After thirty days, participants will be invited to complete the web-based educational program. Thirty days after completion, they will receive a link to a web-based follow up survey.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
47
|
0
|
0
|
52
|
|
Phase 1
COMPLETED
|
47
|
0
|
0
|
52
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
47
|
0
|
0
|
52
|
|
Phase 2
COMPLETED
|
43
|
0
|
0
|
52
|
|
Phase 2
NOT COMPLETED
|
4
|
0
|
0
|
0
|
|
Phase 3
STARTED
|
0
|
26
|
21
|
52
|
|
Phase 3
COMPLETED
|
0
|
26
|
10
|
48
|
|
Phase 3
NOT COMPLETED
|
0
|
0
|
11
|
4
|
Reasons for withdrawal
| Measure |
Site 1 Phases 1 and 2
Participants from the hospital randomized to the experimental group will be first to receive an invitation to complete the web-based educational program. The program will be open for one month. Thirty days after a participant completes the program, they will be sent a link to a follow up survey (web-based).
|
Site 1 Phase 3: Follow-up Survey
At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey.
|
Site 1 Phase 3: 1:1 Interview
At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey and participate in a 1:1 interview.
|
Site 2
Participants from the hospital randomized to the control setting will receive an invitation to complete a survey that collects baseline data for the outcome (stigma toward perinatal substance use) and demographic information. After thirty days, participants will be invited to complete the web-based educational program. Thirty days after completion, they will receive a link to a web-based follow up survey.
|
|---|---|---|---|---|
|
Phase 2
Lost to Follow-up
|
4
|
0
|
0
|
0
|
|
Phase 3
Lost to Follow-up
|
0
|
0
|
11
|
4
|
Baseline Characteristics
Ethnicity aligns with State Boards of Nursing percentages
Baseline characteristics by cohort
| Measure |
Site 1
n=47 Participants
Participants from the hospital randomized to the experimental group will be first to receive an invitation to complete the web-based educational program. The program will be open for one month. Thirty days after a participant completes the program, they will be sent a link to a follow up survey (web-based). At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey or participate in a 1:1 interview.
|
Site 2
n=52 Participants
Participants from the hospital randomized to the control setting will receive an invitation to complete a survey that collects baseline data for the outcome (stigma toward perinatal substance use) and demographic information. After thirty days, participants will be invited to complete the web-based educational program. Thirty days after completion, they will receive a link to a web-based follow up survey.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.53 years
STANDARD_DEVIATION 11.1 • n=9 Participants
|
34.62 years
STANDARD_DEVIATION .89 • n=9 Participants
|
36 years
STANDARD_DEVIATION 10.07 • n=18 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=9 Participants
|
52 Participants
n=9 Participants
|
99 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
52 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
99 Participants
n=18 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Ethnicity aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
1 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
1 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
1 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
3 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
White
|
45 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
50 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
95 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=9 Participants • Race aligns with State Boards of Nursing percentages
|
0 Participants
n=18 Participants • Race aligns with State Boards of Nursing percentages
|
|
Modified Attitudes About Drug Use in Pregnancy Scale
|
2.89 units on a scale
STANDARD_DEVIATION .54 • n=9 Participants • Aligns with previous work using this scale.
|
2.93 units on a scale
STANDARD_DEVIATION .63 • n=9 Participants • Aligns with previous work using this scale.
|
2.91 units on a scale
STANDARD_DEVIATION .59 • n=18 Participants • Aligns with previous work using this scale.
|
PRIMARY outcome
Timeframe: Baseline (Phase 1a); immediately post intervention (Site 1) or 7-30 days post baseline (Site 2) (Phase 1b); immediately post (Site 2) or 30 days post intervention (Site 1) (Phase 2); 30 days post (Site 2) or 60 days post intervention (Site 1) (Phase 3)Population: Phase 3: Interview Site 2 group did not participate in interviews.
Negative or stigmatizing attitudes and/or beliefs registered nurses have towards perinatal substance use; measured using the Modified Attitudes About Drug Use in Pregnancy Scale. Total scores range between 1 and 5, with scores closer to 1 associated with a more positive outcome.
Outcome measures
| Measure |
Site 1
n=47 Participants
Participants from the hospital randomized to the experimental group will be first to receive an invitation to complete the web-based educational program. The program will be open for one month. Thirty days after a participant completes the program, they will be sent a link to a follow up survey (web-based). At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey or participate in a 1:1 interview.
|
Site 2
n=52 Participants
Participants from the hospital randomized to the control setting will receive an invitation to complete a survey that collects baseline data for the outcome (stigma toward perinatal substance use) and demographic information. After thirty days, participants will be invited to complete the web-based educational program. Thirty days after completion, they will receive a link to a web-based follow up survey.
|
|---|---|---|
|
Nurse Stigma Toward Perinatal Substance Use
Phase 1a
|
2.89 score on a scale
Standard Deviation .5
|
2.93 score on a scale
Standard Deviation .6
|
|
Nurse Stigma Toward Perinatal Substance Use
Phase 1b
|
3.54 score on a scale
Standard Deviation .6
|
3.1 score on a scale
Standard Deviation .6
|
|
Nurse Stigma Toward Perinatal Substance Use
Phase 2
|
3.32 score on a scale
Standard Deviation .6
|
3.34 score on a scale
Standard Deviation .6
|
|
Nurse Stigma Toward Perinatal Substance Use
Phase 3: Survey
|
3.27 score on a scale
Standard Deviation .62
|
3.27 score on a scale
Standard Deviation .7
|
|
Nurse Stigma Toward Perinatal Substance Use
Phase 3: Interview
|
3.75 score on a scale
Standard Deviation .31
|
—
|
SECONDARY outcome
Timeframe: immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2)The level of satisfaction participants have towards the intervention; measured using an adapted version of the Abbreviated Acceptability Rating Profile. Total scores range from 1 to 5 with scores closer to 5 representing a more positive outcome.
Outcome measures
| Measure |
Site 1
n=47 Participants
Participants from the hospital randomized to the experimental group will be first to receive an invitation to complete the web-based educational program. The program will be open for one month. Thirty days after a participant completes the program, they will be sent a link to a follow up survey (web-based). At 60 days, participants who completed the program and the first follow up survey will be randomized to complete a second follow up survey or participate in a 1:1 interview.
|
Site 2
n=52 Participants
Participants from the hospital randomized to the control setting will receive an invitation to complete a survey that collects baseline data for the outcome (stigma toward perinatal substance use) and demographic information. After thirty days, participants will be invited to complete the web-based educational program. Thirty days after completion, they will receive a link to a web-based follow up survey.
|
|---|---|---|
|
Acceptability
|
3.95 score on a scale
Standard Deviation .43
|
3.89 score on a scale
Standard Deviation .54
|
Adverse Events
Site 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Site 2
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
Clayton Shuman, PhD, MSN, RN; Associate Professor
University of Michigan
Phone: 734-763-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place