Nurse's RoleNCT06410287

Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use

A study testing ArtSpective in people with Nurse's Role and Stigma, Social, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this pilot clinical trial is to evaluate the feasibility and limited effectiveness of a digital, arts-based educational intervention addressing nurse stigma towards perinatal substance use. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nurse's Role, Stigma, Social, Implicit Bias
What is being tested?: ArtSpective
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 2 sitesUnited States
Study dates: 1 Jul 2024to 30 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18 years or older
Licensed as a registered nurse
Works at least part time
Works on a labor, postpartum, nursery, neonatal intensive care, or pediatric unit in one of the participating hospitals

Who cannot join

Works as per diem or agency nurse
Not employed by a participating hospital
Not a perinatal/pediatric nurse

Trial locations and contacts

2 sites in 1 country.

United States2 sites

St. Cloud Hospital
Saint Cloud, Minnesota, 56303
ProMedica Toledo Hospital
Toledo, Ohio, 43606

Other trials in United States

About this study

Official title: Feasibility of an Art-based Intervention to Address Clinician Stigma and Improve Care for Neonatal Opioid Withdrawal Syndrome

What is the the feasibility of delivering the training through an asynchronous, web-based platform?
What is the limited effectiveness of the program on nurse stigma towards perinatal substance use?

Participants will access and complete the training, including completion of a perinatal substance use stigma scale at baseline, immediately post, and 1-2 months month later. Participants will also be invited to participate in an interview.

Researchers will compare the intervention and control groups to see if the training reduces nurse stigma towards perinatal substance use.

Conditions: Nurse's Role, Stigma, Social, Implicit Bias
Being tested: ArtSpective
Medical subject headings: Social Stigma, Bias, Implicit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ArtSpectiveOther
ArtSpective is an interactive, educational program that uses art and museum-based pedagogy. The intervention is delivered asynchronously using a web-based platform. Participants engage with artwork, watch short educational videos, and read short clinical vignettes. After completing the program, participants receive a certificate of completion.

Study groups in NCT06410287
Study group	Role	What they receive
Site 1	Experimental	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. Receives: Other: ArtSpective
Site 2	Other	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. Receives: Other: ArtSpective

What is being measured

The primary outcome is the main question the study is designed to answer.

Nurse Stigma Toward Perinatal Substance Use
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.
Measured: 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)

Secondary outcomes (1)

Acceptability
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.
Measured: immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202430 Nov 2024

First posted13 May 2024
Study start1 Jul 2024
Primary completion30 Nov 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nurse's RoleStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06410287
Sponsor's protocol ID: HUM00248695
Other IDs: R21DA055067
Status last verified: Mar 2026
First submitted: 7 May 2024
Last updated: 11 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified data may be shared upon request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of an Art-based Intervention to Address Clinician Stigma and Improve Care for Neonatal Opioid Withdrawal Syndrome
ClinicalTrials.gov ID: NCT06410287
Acronym / sponsor ID: HUM00248695
Conditions: Nurse's Role, Stigma, Social, Implicit Bias
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Jul 2024 (actual)
Primary completion: 30 Nov 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 13 May 2024 (actual)
Results: Posted 11 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

What is the the feasibility of delivering the training through an asynchronous, web-based platform?
What is the limited effectiveness of the program on nurse stigma towards perinatal substance use?

Researchers will compare the intervention and control groups to see if the training reduces nurse stigma towards perinatal substance use.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Site 1	Experimental	Other: ArtSpectiveParticipants 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	Other	Other: ArtSpectiveParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 years or older
Licensed as a registered nurse
Works at least part time
Works on a labor, postpartum, nursery, neonatal intensive care, or pediatric unit in one of the participating hospitals

Key exclusion criteria (3 listed)

Works as per diem or agency nurse
Not employed by a participating hospital
Not a perinatal/pediatric nurse

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ArtSpectiveArtSpective is an interactive, educational program that uses art and museum-based pedagogy. The intervention is delivered asynchronously using a web-based platform. Participants engage with artwork, watch short educational videos, and read short clinical vignettes. After completing the program, participants receive a certificate of completion.	Other	Site 1, Site 2

Primary outcome

Nurse Stigma Toward Perinatal Substance Use
Time frame: 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)
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.

1 secondary outcome

Acceptability
Time frame: immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2)

Results and safety

Results posted to the registry on 11 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Site 1 Phases 1 and 2	47	47
Site 1 Phase 3: Follow-up Survey	0	0
Site 1 Phase 3: 1:1 Interview	0	0
Site 2	52	52

Primary outcome: Nurse Stigma Toward Perinatal Substance Use

Time frame: 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). Mean (Standard Deviation). Unit: score on a scale

Measure	Site 1 n = 47	Site 2 n = 52
Phase 1a	2.89 (.5)	2.93 (.6)
Phase 1b	3.54 (.6)	3.1 (.6)
Phase 2	3.32 (.6)	3.34 (.6)
Phase 3: Survey	3.27 (.62)	3.27 (.7)
Phase 3: Interview	3.75 (.31)	–

Site 1 vs Site 2: p <.05, t-test, 2 sided

Population analysed: Phase 3: Interview Site 2 group did not participate in interviews.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up (up to 2 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Site 1	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Site 2	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified data may be shared upon request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ArtSpective in people with Nurse's Role and Stigma, Social, run by University of Michigan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nurse Stigma Toward Perinatal Substance Use (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06410287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.