NCT06410287

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

May 7, 2024

Results QC Date

October 15, 2025

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2)

Study Arms (2)

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.

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.

Other: ArtSpective

Interventions

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.

Site 1Site 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Social StigmaBias, Implicit

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPrejudice

Results Point of Contact

Title
Clayton Shuman, PhD, MSN, RN; Associate Professor
Organization
University of Michigan

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 13, 2024

Study Start

July 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 11, 2026

Results First Posted

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

De-identified data may be shared upon request.

Locations