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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA055067 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArtSpective | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States | ||
| ProMedica Toledo Hospital |
De-identified data may be shared upon request.
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Participants were recruited from two hospitals in July 2024. The study aimed to recruit up to 75 participants from each hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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| Phase 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of the participant in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Phase 3: Interview Site 2 group did not participate in interviews. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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from enrollment until end of follow-up (up to 2 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Shuman, PhD, MSN, RN; Associate Professor | University of Michigan | 734-763-1302 | clayshu@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2024 | Oct 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2024 | Oct 15, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2024 | Oct 15, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| D000087302 | Bias, Implicit |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D011287 | Prejudice |
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| Toledo |
| Ohio |
| 43606 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Sex of the participant defined as Male or Female. | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Ethnicity of the participant as self-reported. | Ethnicity aligns with State Boards of Nursing percentages | Count of Participants | Participants |
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| Race (NIH/OMB) | Race of participant as self-reported. | Race aligns with State Boards of Nursing percentages | Count of Participants | Participants |
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| Modified Attitudes About Drug Use in Pregnancy Scale | Higher scores reflect less stigma; lower scores reflect higher stigma. | Aligns with previous work using this scale. | Mean | Standard Deviation | units on a scale |
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| OG001 | 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | immediately post intervention (Site 1= Phase 1b; Site 2 = Phase 2) |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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. | 0 | 52 | 0 | 52 | 0 | 52 |
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