Indigenous Recovery Planning for American Indians

Sponsor
Montana State University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05612061
Collaborator
(none)
160
1
2
39
4.1

Study Details

Study Description

Brief Summary

This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck community members to deliver manualized intervention content to American Indian adults with substance use disorder (SUD). By increasing access to culturally responsive evidence-based treatment, this research aims to decrease SUD-related health disparities and improve public health outcomes for underserved Native communities locally and nationally.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Indigenous Recovery Planning
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Wait-list control groupWait-list control group
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Indigenous Recovery Planning for American Indians
Actual Study Start Date :
Nov 2, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Receives Indigenous Recovery Planning (IRP) intervention, which includes 6 weekly group intervention sessions lasting about 2 hours each.

Behavioral: Indigenous Recovery Planning
The Indigenous Recovery Planning (IRP) intervention consists of a 6-week group-based intervention. Each of the 6 weekly sessions is delivered by a community member facilitator. Facilitators lead the group through a series of culturally adapted relapse prevention exercises designed to change their substance use. Focus areas for the 6 sessions are: 1) introduction and goal setting; 2) relapse and recovery; 3) craving, mindfulness, and self-compassion; 4) coping with trauma and stress; 5) enlisting social support for recovery; 6) envisioning and planning for the future.

No Intervention: Waitlist Control Group

Participants in the waitlist control group do not receive the intervention until after treatment group completes the intervention. Outcomes will be compared between the 2 study arms at baseline and at follow-up, at which point the treatment group will have completed the intervention and the waitlist control group will have not yet been exposed to the intervention, thereby serving as the control group.

Outcome Measures

Primary Outcome Measures

  1. Percent days absent [At Time 1, we will assess alcohol and drug use in the 90 days prior to assessment, and each subsequent assessment will measure use in the time since the previous one (approximately 6 weeks).]

    Percent days absent will be measured using the Timeline Followback (TLFB), a widely used calendar-based recall instrument shown to yield valid and reliable estimates of substance use behavior. Additional analyses will be conducted with other variables derived from TLFB data, including number of drinks per drinking day, percent heavy drinking days, and percent drug use days.

Secondary Outcome Measures

  1. Number of substance-related consequences experienced within the past 6 weeks [Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)]

    Measured by the Drinker Inventory of Consequences, modified for alcohol and drug use

Other Outcome Measures

  1. Quality of life score [Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)]

    Measured by the World Health Organization Brief Quality of Life Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Indian, 18 years of age or older, living on the Fort Peck reservation, meeting diagnostic criteria for Substance Use Disorder, wanting treatment/help with recovery.
Exclusion Criteria:
  • Not meeting inclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fort Peck Community College Poplar Montana United States 59255

Sponsors and Collaborators

  • Montana State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montana State University
ClinicalTrials.gov Identifier:
NCT05612061
Other Study ID Numbers:
  • 5R01DA053791-02
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022