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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA040316-07S3 | 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 purpose of this study is to develop a culturally relevant Facebook intervention for American Indian and Alaska Native (AIAN) women in Minnesota recovering from illicit opioid use.
This one-year, Phase I, pilot preparatory study aims to develop a culturally relevant Facebook intervention for American Indian and Alaska Native (AIAN) women in Minnesota recovering from illicit opioid use. The study will consist of three phases: (1) qualitative interviews, (2) intervention content refinement and a moderator exchange (i.e., bi-directional sharing of knowledge between intervention moderators and trainers), and (3) a beta-testing period. A study-specific Community Advisory Committee (CAC) was formed whose members contributed to the study protocol and will continue to provide guidance and input on the study implementation and dissemination. At the advice of the CAC, a Native Elder woman named the study. Wiidookaage'win is an Ojibwe word that means "the place for help and time for helping," and reflects healing and community. The investigators expect the participatory approach to treatment development will result in a social media intervention with cultural relevance for Native women to maintain recovery from opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facebook Intervention | Experimental | In Phase 3, all participants will receive the same intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wiidookaage'win Facebook Group | Behavioral | A 30-day Facebook group prototype that is moderated by two women who will post various forms of media addressing opioid recovery, mindfulness, stress management, and resiliency. |
| Measure | Description | Time Frame |
|---|---|---|
| The Feasibility of Developing a Culturally Relevant Facebook Intervention | The number of times participants engaged with the Facebook page. Define by the total times of viewing, reacting, posting, commenting and voting on any Facebook post for all participants. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Feasibility of Using Facebook as an Opioid Intervention Platform | The number of participants who completed all study activities from baseline to end of study. | 30 days |
| Treatment Satisfaction |
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Inclusion Criteria - Phase 1:
AIAN Women:
AI/AN Health Care Providers and Stakeholders
Having some familiarity with the Facebook platform is needed to provide feedback on content for a Facebook intervention. Access to the internet is needed to view online moderator postings for providing feedback during the interview.
Inclusion Criteria - Phase 3:
Exclusion Criteria:
AIAN potential participants in Phases 1 and 3 meeting any of the exclusion criteria listed below will be excluded from study participation. Community stakeholder participants in - Phase 1 will only fail the screening if they meet the second exclusion criterion:
Pregnant women, lactating women, or women who plan to become pregnant will not be excluded because the treatment being evaluated is a behavioral intervention and does not involve medication or risk to the fetus.
The AI/AN participants can be either transgender or cisgender women.
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| Name | Affiliation | Role |
|---|---|---|
| Christi Patten, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37955409 | Background | Young A, Sinicrope P, Kelpin S, Roche AI, Sabaque C, Pham C, Marsch LA, Campbell ANC, Venner K, Bastian E, Nord T, Mason G, Baker L, Wyatt T, Fish A, Bart G, Patten CA. Wiidookaage'Win: A Community-Based Qualitative Approach to Developing a Facebook Group Intervention for Native Women to Support Recovery From Opioid Use. Am J Health Promot. 2024 Feb;38(2):205-218. doi: 10.1177/08901171231205355. Epub 2023 Nov 13. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facebook Intervention | Subjects were emailed an invite link for the Facebook Intervention. Wiidookaage'win Facebook Group: A 30-day Facebook group prototype that was moderated by two women who posted various forms of media addressing opioid recovery, mindfulness, stress management, and resiliency. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Facebook Intervention | Subjects were emailed an invite link for the Facebook Intervention. Wiidookaage'win Facebook Group: A 30-day Facebook group prototype that was moderated by two women who posted various forms of media addressing opioid recovery, mindfulness, stress management, and resiliency. |
| 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 | Mean |
| 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 | The Feasibility of Developing a Culturally Relevant Facebook Intervention | The number of times participants engaged with the Facebook page. Define by the total times of viewing, reacting, posting, commenting and voting on any Facebook post for all participants. | Posted | Median | Full Range | engagement events | 30 days |
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Adverse events were collected from baseline to end of study, approximately 30 days
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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 | Facebook Intervention | Subjects were emailed an invite link for the Facebook Intervention. Wiidookaage'win Facebook Group: A 30-day Facebook group prototype that was moderated by two women who posted various forms of media addressing opioid recovery, mindfulness, stress management, and resiliency. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christi A Patten, Ph.D. | Mayo Clinic | 507-266-2554 | patten.Christi@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2023 | May 17, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2023 | Sep 5, 2023 | ICF_000.pdf |
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All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
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This is a single arm study where every participant in Phase 3 will receive the same single intervention.
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Treatment Satisfaction was measured using a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Total scores range from 1 -5. Higher scores indicate greater satisfaction and lower scores indicate lower satisfaction.
| 30 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | The Feasibility of Using Facebook as an Opioid Intervention Platform | The number of participants who completed all study activities from baseline to end of study. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Treatment Satisfaction | Treatment Satisfaction was measured using a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Total scores range from 1 -5. Higher scores indicate greater satisfaction and lower scores indicate lower satisfaction. | One subject did not complete the post-intervention survey.. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
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| 0 |
| 10 |
| 0 |
| 10 |
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| 10 |
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