Clinical trial NCT05340855: A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women
Official title: Facebook Intervention for Preventing Opioid Relapse Among American Indian Women: Wiidookaage'Win Pilot Preparatory Study (Aim 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: American Indian
Alaska Native
Community Based Participatory Research
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Feasibility of Developing a Culturally Relevant Facebook Intervention
timeFrame: 30 days
Secondary outcomes:
measure: The Feasibility of Using Facebook as an Opioid Intervention Platform
timeFrame: 30 days
measure: Treatment Satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christi Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.