Evidence map›Paper›PMID 42401232›Full record

Trial reportContemporary clinical trials2026

The sequential cohort randomized clinical trial: A study design for community-engaged clinical research in a rural American Indian community.

Monica C Skewes, Vivian M Gonzalez, Eliza Webber, Julie A Gameon, Benjamin Oosterhoff, Alexandra K Adams

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05612061 (Randomized Controlled Trial of Indigenous Recovery Planning for American Indians), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05612061 nacompletednot on this map

Randomized Controlled Trial of Indigenous Recovery Planning for American Indians

TypeinterventionalSponsorMontana State UniversityRan2022 to 2026Enrolled201ConditionsAlcohol Use Disorder, Substance Use DisordersArmsIndigenous Recovery Planning
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Monica C SkewesDepartment of Psychology, Montana State University, United States of America. Electronic address: monica.skewes@montana.edu.
Vivian M GonzalezDepartment of Psychology, University of Alaska Anchorage, United States of America.
Eliza WebberCenter for American Indian and Rural Health Excellence, Montana State University, United States of America.
Julie A GameonDepartment of Psychology, Montana State University, United States of America.
Benjamin OosterhoffMeadows Mental Health Policy Institute, United States of America.
Alexandra K AdamsCenter for American Indian and Rural Health Excellence, Montana State University, United States of America.

Funding

Randomized Controlled Trial of Indigenous Recovery Planning for American IndiansR01DA053791 · NIDA · MONTANA STATE UNIVERSITY - BOZEMAN · PI SKEWES, MONICA C · 2021 to 2025
$3.2M
NIDA NIH HHS R01 DA053791
6 · The paper itself

Abstract

Health disparities facing American Indian and Alaska Native (AI/AN) populations warrant effective behavioral health interventions that are grounded in culture and Indigenous worldviews, but AI/AN people remain underrepresented in clinical trials. Rigorous scientific methods are needed to determine the efficacy of new interventions, particularly in small rural communities with high treatment need and low access to care. However, many AI/AN communities prefer study designs that ensure all participants receive an intervention, and logistical constraints, such as small population sizes and limited staffing, can impede fully powered randomized controlled trials. This manuscript presents the Sequential Cohort Randomized Clinical Trial (SC-RCT), a study design developed through an academic-community partnership to test the efficacy of a behavioral intervention for substance use disorders in a rural AI reservation community. The SC-RCT differs from existing staggered rollout designs (e.g., stepped wedge, dynamic wait-listed) by using sequential cohort enrollment with individual-level randomization, allowing sample size to accrue over time while standardizing waitlist duration and intervention dosage across participants. This approach preserves a randomized comparison between immediate and delayed treatment conditions while accommodating staffing and recruitment constraints. The SC-RCT offers a feasible and culturally responsive option when traditional designs are not practical, and may be especially useful in small or under-resourced populations where equitable access and limited implementation capacity are key considerations. In AI/AN and other communities, this design may help overcome logistical barriers to research and support ethical and effective interventions in community settings. Clinicaltrials.gov ID number: NCT05612061.

Indexed as

American Indian or Alaska NativeCommunity-Based Participatory ResearchSubstance-Related DisordersHumansPatient SelectionResearch DesignRural PopulationAmerican IndianClinical trial designCommunity-engaged researchSequential cohort randomized clinical trialSmall populations

Identifiers

PMID42401232
PMCPMC13394505

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.