Feasibility of an Art-based Intervention to Address Clinician Stigma and Improve Care for Neonatal Opioid Withdrawal Syndrome
Phase: NA
Conditions: Nurse's Role, Stigma, Social, Implicit Bias
Sponsor: University of Michigan

TITLE: Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use 
 
NCT NUMBER: NCT06410287 
 
VERSION DATE: 6/13/24 
 
 

 
Principal Investigator: Clayton Shuman, PhD, MSN, RN 
Co-Investigators: Carol Boyd, PhD, RN, FIAAN, FAAN; Michael Rubyan, PhD, MPH; Deanna Isaman, PhD 
Research Staff: Mikayla Morgan, BSN, RN, CCRN; Bethany Emery, BSN, RN 
Funding: NIH-NIDA - R21DA055067 
 
BACKGROUND AND AIMS 
Between 2010 and 2017, perinatal opioid use (POU) at time of delivery significantly increased from 3.5 to 8.2 per 1000 hospital 
deliveries.17 POU results in numerous negative outcomes for infants, including neonatal opioid withdrawal syndrome (NOWS), 
which is a drug withdrawal syndrome following birth associated with symptoms such as low birthweight, respiratory distress, 
feeding difficulties, poor weight gain, inconsolability, seizures, prolonged hospital stays, and separation of infant from their 
mother.20-27,41-42 Recent studies support prioritization of maternally-provided care (e.g., breastfeeding, skin-to-skin), 
demonstrating increased maternal presence at infant bedsides (rooming-in) and involvement in infant care improves infant 
outcomes, including decreased symptom severity and reduction in pharmacologic treatment (83.3% to 14.3%), length of 
pharmacologic treatment and hospital stay (25 to 8 days), and costs.43-51 However, these care approaches are not well 
implemented and vary widely,43-44 partially due to stigmatizing attitudes of nurses who regularly care for and interact with these 
mothers and infants.  
 
In a multisite study, over half of registered nurses (RNs) had heightened stigmatizing attitudes toward POU and NOWS with 
little variation across hospitals (48.8-58%).1Most RNs believed these mothers are manipulative and unreliable (81%) and 
responsible for the damage done to their infants (69%). The majority felt mothers were guilty of child abuse (64%) and should 
go to jail (61%). These negative attitudes can impede engagement of mothers as primary caregivers to the infants,4 leading to 
decreased breastfeeding rates, heightened severity of infant withdrawal, prolonged hospital stays, and increased likelihood of 
maternal-infant separation (e.g., decreased maternal visits to hospitalized infant; loss of custody).43-51,61 Addressing RN attitudes 
toward POU and NOWS can improve maternal engagement and infant health outcomes.  
 
The relationships among art and health behaviors and outcomes are well established.38-39 For example, art therapy has 
demonstrated effectiveness in improving attention, pleasure, social behavior, self-esteem, and neuropsychiatric symptoms in 
patients with Alzheimer’s disease and/or other dementias.37 For patients with mental illness and substance use disorders, art 
therapy improves self-confidence, sociability, and well-being.40 Narrative and creative writing and storytelling improves pain, 
fatigue, immune system function, interpersonal relationships, attitudes/feelings, and perspective taking while additionally 
reducing health services utilization and stigmatizing and judgmental attitudes and actions.31,38 Art interventions are novel and 
highly effective in changing human psychology and behaviors but are overtly underutilized in clinical education.31,38 George et 
al. used creative storytelling to effectively improve clinician attitudes toward a stigmatized patient population: persons with 
dementia.36 Thus, there is precedent for using art pedagogy to improve clinician attitudes toward stigmatized populations.   
 
ArtSpective targets and improves RN attitudes toward POU and NOWS as an arts-based intervention delivered asynchronously. 
It has been adapted from and is informed by preliminary work of the research team.1,4,53,60 ArtSpective facilitates perspective 
taking exercises using curated paintings and photographs and narrative storytelling. Perspective taking is described as taking the 
point of view of another person within the other’s context.62 For example, a nurse is engaging in perspective taking when he/she 
understands a mother’s experience and perspective of POU and NOWS. It is not applying one own’s point of view to the 
context of another’s experience (eg, nurse applies own perspective to the mother’s experience). Taking the viewpoint of someone 
in distress (eg, mother affected by POU) is considered necessary for taking actions and exerting behaviors to alleviate that distress 
and improve outcomes (eg, breastfeeding; skin-to-skin care; understanding how social determinants of health lead to maternal 
absence at infant bedsides).62 ArtSpective facilitates perspective taking to improve RN stigmatizing attitudes toward POU and 
NOWS, leading to improved engagement of mothers in providing recommended NOWS care and ultimately aims at improving 
maternal and infant health outcomes.   
 
In 2020, ArtSpective was pilot tested using a pre-post design and sample of senior undergraduate and graduate nursing students 
(N=11) interested in maternal-infant health.30 A significant improvement in self-reported attitudes toward POU and NOWS (t= 
4.11, p=.002; Cohen’s d= .633) was observed. Despite these early signals of efficacy and feasibility, ArtSpective’s previous 
delivery format (synchronous group intervention facilitated live through video conference) was neither scalable nor sustainable. 
Since, ArtSpective has been adapted to a fully asynchronous and digital product that improve scalability and sustainability. 
Feasibility of this adapted version needs to be rigorously evaluated as well as the direction, magnitude, and sustainability of its 
effect on RN attitudes toward POU and NOWS.   
The ArtSpective digital platform consists of a 30-minute web-based session that RNs can complete asynchronously. The program 
is self-paced and synchronous. Modules (see table below) are based on five learning objectives and core competencies developed 

by PI Shuman and Co-Is Rubyan and Boyd, with input from the U-M Museum of Art.30 Once RNs have completed pre-course 
tasks, modules will open sequentially. Each module will consist of interactive elements (eg, videos, text-entry, animated graphics, 
select from a list) and will remain locked until the previous module is completed to ensure a high-fidelity user experience. At the 
conclusion of the intervention, RNs will receive a downloadable certificate of completion with facts about POU and NOWS, 
and the strategies (actions) they can take to improve engagement of mothers in care of infants with NOWS. 
 
 
Accordingly, specific aim is to: Test the feasibility of the adapted ArtSpective intervention, including acceptability, adaptation, 
study logistics, and practicality. 
 
THEORETICAL MODEL & ADAPTATION FRAMEWORK 
Our study and the ArtSpective intervention are informed by Corrigan’s model of stigma63 and the Emancipatory Theory of 
Compassion.64 Substance use disorder is among the most highly stigmatizing conditions and leads to discriminatory actions 
against vulnerable individuals.65 In healthcare, stigma and discriminatory actions are considerable barriers to health-seeking 
behaviors and engagement in healthcare.65-66 For NOWS treatment, maternal engagement in infant care is recommended because 
it improves infant outcomes. However, stigmatizing attitudes of RNs can result in discriminatory actions against mothers (eg, 
failure of RNs to engage mothers or provide opportunities for mothers to provide in infant care) and maternal absence at infant 
bedsides in an effort to avoid suffering from stigmatizing attitudes and discriminatory actions.65-66 In the nursing discipline, 
compassion (wanting others to be free of suffering) is a necessary component of emancipatory practice which recognizes the 
effect of power relations on suffering.67 The Emancipatory Theory of Compassion emphasizes relationships among nurses and 
patients within the broader context of health care delivery, health policy, and social justice issues including biases and judgments 
toward POU.64 Its main assertion is that RNs must decrease patient, community, and population suffering through sharing 
power, increasing compassion, and enhancing the voice and agency of others. ArtSpective improves RN attitudes toward POU 
and NOWS and encourages maternal agency in providing care to infants.30 By addressing stigmatizing attitudes which disrupt 
compassionate practice and praxis, RNs will be better prepared to engage mothers in infant care, empower mothers to participate 
as members of the care team, and improve implementation of evidence-based maternal-infant dyadic NOWS care and related 
outcomes (eg, length of stay; bonding; withdrawal severity; treatment adherence, relapse prevention).65,66,30  
 
Adaptation Framework 
We will apply the ADAPT-ITT model, originally used for adapting HIV interventions, but has demonstrated utility for other 
health interventions.97 The model and will guide testing of an asynchronous web-based version of ArtSpective that is intended 
to be both scalable and sustainable. The research team has developed ArtSpective as an asynchronous, interactive, web-based 
tool. ArtSpective is now ready to be tested using a pilot cluster randomized trial among perinatal nurses. The ADAPT-ITT 
model consists of eight phases: 1) Assessment, 2) Decision, 3) Adaptation, 4) Production, 5) Topical expert review, 6) 
Integration, 7) Training, and 8) Testing.97 Our team has already completed Phases 1-7. For this study, we will utilize phase 8 as 
a guide. 
 
METHODS 
STUDY DESIGN 
ArtSpective Components (Adapted version) 
Component Objective 
Summary of Content 
Pre-course 
Tasks 
Create username and password; complete pre-
intervention questionnaire 
Create login credentials; complete demographics; 
complete Modified Attitudes About Pregnancy Scale 
Module 1 
Understand one’s own perspective of POU and 
NOWS 
Select art; read directions; write a creative narrative 
from their own perspective. 
Module 2 
Understand POU and NOWS from the mother’s 
perspective 
Select new art; read directions; write a creative narrative 
from the mother’s perspective. 
Module 3 
Compare perspectives 
Watch 1 short, animated video discussing the 
importance of perspective taking in everyday life 
Module 4 
Describe experiences and trajectories of mothers 
and infants affected by POU 
Navigate through a series of short clinical vignettes 
presenting hypothetical stories about POU and NOWS. 
Watch a short, animated video about strategies to 
decrease stigma towards POU and NOWS 
Post-course 
Tasks 
Complete post survey; Obtain certificate of 
completion 
Post survey includes Modified Attitudes About Drug 
Use in Pregnancy, Abbreviated Acceptability Rating 
Profile; and Satisfaction questions; Downloadable 
certificate and personalized report 

We are conducting a pilot experimental study using two matched hospitals to examine feasibility. We will recruit 150 participants, 
75 participants from each hospital, which is a sample size powered for a pilot experimental trial examining feasibility.102-103  One 
recruitment site will be randomly selected to receive the educational intervention first (Site A), while the other site will serve as 
a control site (Site B) during phase 1 (month 1). In phase 2 (month 2), participants from Site A will be invited to complete a 
follow up survey while participants from Site B will be invited to complete the educational intervention. In phase 3, 10 
participants from Site A will be randomly selected to complete interviews while the others complete follow up surveys. 
Participants from Site B will also complete follow up surveys in phase 3 (month 3). 
 
We are following Bowen et al.’s suggestions for conducting feasibility studies and assess feasibility on the following dimensions: 
acceptability, demand, adaptation, and practicality.104 Each of these will be examined by nursing unit, years of perinatal nursing 
experience, race/ethnicity, and age. 
 
VARIABLES AND INSTRUMENTS 
Acceptability: Acceptability is defined as participants’ perceptions of ArtSpective’s appropriateness and satisfaction with it.104 We 
will evaluate acceptability using a modified version of the 8-item Abbreviated Acceptability Rating Profile.105 Participants rate 
the extent to which they agree with each item on a 5-point Likert scale (e.g., “This program is a good way to develop compassion 
for women and infants affected by substance use” and “I would recommend this program to others”). We will also include items 
used in our preliminary work including perspectives on logistics (eg, length of the program), delivery format (eg, web-based), 
perceived effectiveness (eg, “Because of this program, I have more compassion toward mothers and infants affected by perinatal 
substance use”) and free-text items (eg, “What was the most beneficial part?”).30 These items will be included on the experimental 
arm’s baseline (post-intervention) and 1-2 month following surveys and asked after completing the M-AADUP scale.52-53 Using 
a semi-structured interview guide, we will conduct 10 in-depth interviews (30 minutes) with participants randomly selected from 
the experimental arm instead of completing 2-month follow-up surveys. Participants will be asked about their attitudes about 
various components of the intervention: look (graphics, colors, artwork), intervention flow, appropriateness of content, ease of 
use, time to complete, and the completion certificate and personalized report card.  
 
Adaptation: Adaptation is defined as the extent to which ArtSpective performs when adapted to a new platform and audience. 
Using a checklist to assess our ability to perform on the key core-components106 of the original intervention using the online 
platform. The key components necessary to successfully adapt the intervention are to provide participants opportunity for 1) 
choosing artwork to engage with, 2) performing narrative writing, and 3) identifying key lessons learned. Practicality: Practicality 
is defined as the extent to which ArtSpective is carried out using existing means and resources and without requiring outside 
intervention.104 We will monitor fidelity (completing ArtSpective as intended) and length (time to complete ArtSpective). We 
will collect data including the number of log-ons, pages visited, and time spent on each page. Study Logistics: We will monitor the 
rate of uptake, time to recruit 75 participants in each arm, and retention rate (from completion to 1 and 2 months later) to inform 
the development of a future efficacy trial. Cost: Although we are not conducting a formal cost analysis, to explore practicality, 
we will monitor costs of intervention development, implementation, and sustainability of the intervention on a web-based 
platform (eg, hosting, maintenance). 
 
Stigmatizing attitudes of RNs toward POU and NOWS. Although not powered to detect change, we will also measure 
stigmatizing attitudes among RNs: this information, which will show the prevalence and potential direction of effect, is needed 
to inform the power of a future efficacy trial. We will collect data on RN stigma toward POU and NOWS using the modified 
Attitudes About Drug Use in Pregnancy (M-AADUP) scale.52-53 The original scale has demonstrated validity and reliability and 
has been updated and revised (with permission) by PI Shuman and Co-I Boyd.53 The modified scale has demonstrated internal 
consistency reliability in our previous studies (Cronbach’s a= .92-.96).1,30,53 The modified version has 22 items, and participants 
rate their agreement with each statement on a 1-5 Likert scale, where lower scores indicate more stigmatizing attitudes. A total 
scale score is calculated by summing values for all items and dividing by the total number of items. Participants in the 
experimental arm will complete the M-AADUP at baseline (both pre- and post-intervention) and at 1 and 2 months later. 
Participants from the control arm will complete it at baseline, immediately preceding and following the intervention, and 1 
month following completion of the intervention.  
 
Demographic information: Participants will also provide demographic information (at baseline) including age in years, 
race/ethnicity, primary unit, average number of hours worked each week, shift type (days, evening, nights, rotate), years of 
experience working in perinatal health, and highest education level. We will also collect demographic data which may be 
moderators including personal or familial history of substance use disorder (using the family history section of the Renard 
Diagnostic Interview107-108), whether a parent (“I am a mother/father”), and approximate number of mothers/infants with POU 
or NOWS cared for in the last year (adapted from Shuman et al1).  
 

STUDY PROCEDURES 
Consent 
After obtaining IRB approval and registering the clinical trial with clinicaltrials.gov, we will begin study activities. All participants 
will consent to participate prior to participation. Prior to participation, participants will be informed of the study purpose and 
their involvement in a study information/informed consent document sent with the recruitment email. 
   
Data Collection 
We are using recordings from videoconference and Qualtrics, a web-based survey application, to collect data. While completing 
the intervention, survey question and demographic questions are embedded in the platform. Zoom, Qualtrics, and ArtSpective 
platform are password protected and data is only available to research team members. Data from recordings will be transcribed 
verbatim prior to analysis.  
 
Randomization 
Participants will be randomized by site. One site will be randomized to the experimental arm (Site A) and the other will serve as 
the control (Site B) during phase 1. During phase 3, we will randomly select 10 individuals from Site A to participate in interviews 
rather than completing a follow up survey. Random selection will be done using site/participant IDs and the “sample( )” function 
in R. 
  
DATA ANALYSIS 
Demographic data from Qualtrics will be migrated from Qualtrics via a comma separated values document, which can be used 
for data cleaning and analysis. Audio recordings from Zoom sessions (Phase 3 interviews) will be transcribed verbatim and 
analyzed using an iterative process and the constant comparative method.98-100 Member checking will contribute to credibility 
through validation of the research findings by participants.100 A codebook will be developed after repeated high-level reading of 
the transcripts. Using NVivo software,101 data will be coded and grouped into categories to facilitate abstraction and concept 
analysis. The written field notes will be analyzed using content analysis to locate statements where RNs and experts referred to 
navigational issues, missing content, or visual flaws. The statements will be organized into categories and lists that refer to 
elements of the intervention design, such as format, content, style, and setting, to make the necessary modifications. These 
methods will help identify and analyze RNs’ thought processes to see how they: 1) relate to the content, 2) interpret the content, 
and 3) make meaning of the information, skills, and resources provided.  
 
Two questions will be analyzed: feasibility and change in stigma. Feasibility of ArtSpective will be analyzed using univariate 
descriptive statistics (proportions, means, and ranges)93 and by comparing differences by unit, years of experience, race/ethnicity, 
and age, using t-tests for continuous variables and test for the difference in proportion for binary variables.109-110 The change in 
stigma score measured by the MAADUP will be analyzed at 2 points in time: 1) immediately following completion of 
ArtSpective, only within the experimental arm, and 2) at 3 months between the experimental and control arms. We will test the 
immediate change using a paired t-test109 of the hypothesis that the change in score is different from zero within RNs who 
received the intervention. We will test the change at 3 months using an independent t-test of the hypothesis that the difference 
over time between the experimental group and the control group is non-zero.109 In addition we will develop a regression model 
for the change in stigma score as a function of covariates such as unit, age, and race. An indicator variable for the experimental 
arm will be used to test the difference between the groups, controlling for the other covariates.111 Stepwise selection will be used 
to identify variables that are most strongly and independently associated with the change in stigma scores.111 For all hypothesis 
tests, we will report p-values and a threshold of .05 will be used to determine significance. We will also examine the difference 
in distribution of stigma score before and after the intervention using the Kolmogorov-Smirnov test.112 This nonparametric test 
for distributions does not require assumptions about the shape of the underlying distributions. To visualize the test results, we 
will construct box plots of the attitude scores at each point of time by intervention group.   
  
Power Calculation 
As a pilot study, our power calculation focuses on only a few outcomes and leaves room for uncertainty in our assumptions. We 
based our sample size estimates on detecting a moderate effect size of 0.5113 which we believe is a meaningful difference for 
these pilot data. Assuming 75 participants in each group, and test performed at alpha level of 5%, the between-group tests would 
have power of 86%, and the paired t-test for immediate change in stigma score would have power greater than 90%. The 3-
month differences will be unpowered at a moderate effect size; however, these pilot data will provide us with an estimate of 
attrition. In addition, estimates of attrition, effect, and correlation will be needed to power a future multisite cluster-randomized 
study.  
 
 

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