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

NCT ID: NCT05340855

Last Updated: 2024-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2023-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

This is a single arm study where every participant in Phase 3 will receive the same single intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Facebook Intervention

In Phase 3, all participants will receive the same intervention.

Group Type EXPERIMENTAL

Wiidookaage'win Facebook Group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wiidookaage'win Facebook Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.


* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christi Patten

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christi Patten, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 37955409 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UG1DA040316-07S3

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-000477

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Trans-Led Care Study
NCT06880705 RECRUITING NA
Indigenous Recovery Planning for American Indians
NCT05612061 ENROLLING_BY_INVITATION NA
The Weaving Healthy Families Program
NCT03924167 ACTIVE_NOT_RECRUITING NA