- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410287
Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use
Feasibility of an Art-based Intervention to Address Clinician Stigma and Improve Care for Neonatal Opioid Withdrawal Syndrome
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. The main questions it aims to answer are:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Saint Cloud, Minnesota, United States, 56303
- St. Cloud Hospital
-
-
Ohio
-
Toledo, Ohio, United States, 43606
- ProMedica Toledo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Works as per diem or agency nurse
- Not employed by a participating hospital
- Not a perinatal/pediatric nurse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Site 1
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.
|
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.
|
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 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.
|
immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00248695
- R21DA055067 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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