A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 1)

Conditions
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Opioid Use

Intervention / Treatment
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* Behavioral: Wiidookaage'win Facebook Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Phase 1: AIAN Women: AIAN based on self-reported race. Gender identity as a woman. Resides in Minnesota. At least 18 years of age age with no upper age limit. OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013). Self-reports at least one month of opioid abstinence based on Timeline Follow-Back (TLFB) interview. Currently receiving MOUD. Is comfortable speaking and reading English. Is familiar with Facebook. Has access to broadband internet on a mobile phone/computer/tablet at any location. AI/AN Health Care Providers and Stakeholders Health care provider or AIAN community stakeholder. Knowledge of Native culture and/or OUD treatment and recovery among AIAN people. Is comfortable speaking and reading English. Is familiar with Facebook. Has access to broadband internet on a mobile phone/computer/tablet at any location. 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: AIAN person based on self-reported race/ethnicity. Gender identity as a woman. At least 18 years of age. Resides in Minnesota. OUD based on the DSM-5 Checklist (American Psychiatric Association, 2013). Self-reports at least one month of abstinence from opioid use based on TLFB interview and negative urine opiate screen. Currently receiving MOUD. Is comfortable speaking and reading English. Has an existing Facebook account or willing to set one up. Is willing and able to participate in the Facebook intervention for one month. Has access to broadband internet on a mobile phone/computer/tablet at any location. Is willing and able to travel to a community clinic in Minneapolis, Minnesota for the UDS. 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: Self-reports current suicidality. Inability or unwillingness of participant to provide verbal consent (Phase 1) or written informed consent (Phase 3). (Phase 3 only) Was a participant in Phase 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facebook Intervention<br>In Phase 3, all participants will receive the same intervention. | Behavioral: Wiidookaage'win Facebook Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of a culturally relevant Facebook intervention prototype to support recovery from opioid use | The expected outcomes are the development of the intervention which includes development and refinement of the content library (yes/no), development and refinement of the Facebook intervention prototype (yes/no), development and refinement of the intervention moderator guidelines (yes/no), and moderators trained (yes/no). The success of the Facebook intervention at supporting recovery from opioid use from the participants' perspective will be assessed in the follow-up survey. Participants will be asked for any technical problems that occurred, advice for improving the moderator postings, and advice for improving the Facebook group. We expect that all outcomes will be achieved at 100% implementation. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of using Facebook as an opioid intervention platform as assessed by the number of participants enrolled out of those screened and the number of participants who complete the follow-up assessments | The study staff will document how many patients screen failed or enrolled in Mayo Clinic's Research Participant Tracking (PTrax) database. Participants who complete the follow-up assessments will be documented in Mayo Clinic's Research Electronic Data Capture (REDCap) database. | 30 days | 
| The acceptability of using Facebook as an opioid intervention platform as assessed by the 13-item Social Media Usability Scale (Lund et al., 2001) and post, reaction, and comment data extracted from Facebook (https://pypi.org/project/facebook-scraper/) | The 13-item Social Media Usability Scale will be administered verbally at the beginning of the 30-day follow-up survey using 5-point Likert scales (1 = Strongly disagree, 5 = Strongly agree). Higher scores will indicate greater satisfaction with the platform. The other measures listed will be calculated into a total engagement score. Higher scores will indicate greater engagement with the intervention. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Indian, Alaska Native, Community Based Participatory Research