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CompletedNCT05612061Updated Jul 7, 2026

Indigenous Recovery Planning for American Indians

An interventional study of Indigenous Recovery Planning in Alcohol Use Disorder and Substance Use Disorders, sponsored by Montana State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Montana State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Alcohol Use Disorder
  • Substance Use Disorders
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In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 201 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Not meeting inclusion criteria.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
201 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralIndigenous 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.

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What researchers measure

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.

    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).

Secondary outcomes

  1. Number of substance-related consequences experienced within the past 6 weeks

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

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

Other outcomes

  1. Quality of life score

    Measured by the World Health Organization Brief Quality of Life Scale

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

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Study locations

1 site
  • Fort Peck Community College
    Poplar, Montana 59255, United States
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References and documents

Publications

  • Skewes MC, Gonzalez VM, Webber E, Gameon JA, Oosterhoff B, Adams AK. The sequential cohort randomized clinical trial: A study design for community-engaged clinical research in a rural American Indian community. Contemp Clin Trials. 2026 Jul 4:108389. doi: 10.1016/j.cct.2026.108389. Online ahead of print. PubMed 42401232 ↗

Individual participant data

Plan to share: No — The data belong to the tribal community; data may be shared upon request to the tribe.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05612061
Lead sponsor
Montana State University
Responsible party
Sponsor
First posted
Nov 10, 2022
Start date
Nov 2, 2022
Primary completion
May 6, 2026
Completion
May 6, 2026
Last update
Jul 7, 2026

Study contacts

Monica Skewes, PhD
principal investigator · Montana State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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