Indigenous Recovery Planning for American Indians

July 10, 2025 updated by: Montana State University

Randomized Controlled Trial of Indigenous Recovery Planning for American Indians

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.

Study Overview

Status

Enrolling by invitation

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Montana
      • Poplar, Montana, United States, 59255
        • Fort Peck Community College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Receives Indigenous Recovery Planning (IRP) intervention, which includes 6 weekly group intervention sessions lasting about 2 hours each.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent days absent
Time Frame: 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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of substance-related consequences experienced within the past 6 weeks
Time Frame: 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
Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: 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
Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Monica Skewes, PhD, Montana State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 5R01DA053791-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data belong to the tribal community; data may be shared upon request to the tribe.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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