NCT05340855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 20, 2024

Completed
Last Updated

June 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

April 7, 2022

Results QC Date

April 20, 2024

Last Update Submit

May 28, 2024

Conditions

Opioid Use

Keywords

American IndianAlaska NativeCommunity Based Participatory Research

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • The Feasibility of Using Facebook as an Opioid Intervention Platform

    30 days

  • Treatment Satisfaction

    30 days

Study Arms (1)

Facebook Intervention

EXPERIMENTAL

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

Behavioral: Wiidookaage'win Facebook Group

Interventions

Wiidookaage'win Facebook GroupBEHAVIORAL

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.

Facebook Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe AI/AN participants can be either transgender or cisgender women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +15 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 37955409BACKGROUND

Related Links

Results Point of Contact

Title
Christi A Patten, Ph.D.
Organization
Mayo Clinic
patten.Christi@mayo.edu
507-266-2554

Study Officials

  • Christi Patten, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is a single arm study where every participant in Phase 3 will receive the same single intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All study participants in Phase 3 beta test will be in the same Facebook group intervention and will view the same content.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 22, 2022

Study Start

May 5, 2022

Primary Completion

June 8, 2023

Study Completion

June 8, 2023

Last Updated

June 20, 2024

Results First Posted

June 20, 2024

Record last verified: 2024-05

Locations

US(1)