NCT05612061

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

November 3, 2022

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent days absent

    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 Outcomes (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)

Other Outcomes (1)

  • Quality of life score

    Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Behavioral: Indigenous Recovery Planning

Waitlist Control Group

NO INTERVENTION

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.

Interventions

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.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Peck Community College

Poplar, Montana, 59255, United States

Location

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Monica Skewes, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Wait-list control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

November 2, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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

Locations