We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth

NCT03694418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2026-02-27

Study results available
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Summary

N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for American Indian youth. N/E includes: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs American Indian youth with adults and elders to discuss traditional American Indian beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for American Indian youth. The overarching aim of this proposal is to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design (SWD), in which 5 schools that American Indian youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for cross-contamination. N/E is a 5-year study involving 456 14- to 18-year-old American Indian youth.

Conditions

  • Reproductive Behavior
  • Sexual Behavior

Interventions

BEHAVIORAL

We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth

N/E will be implemented simultaneously over the 9-month school year. Components include: 1) Individual Level- Native Stand 2) Family Level - Native Voices; 3) Community Level - Cultural mentoring program; and 4) Systems Level. The fourth level of N/E mobilizes the existing Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.

Sponsors & Collaborators

  • Northern Arizona University

    collaborator OTHER
  • Fort Peck Community College

    collaborator UNKNOWN
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Montana State University

    lead OTHER

Principal Investigators

  • Elizabeth L Rink, PhD · Montana State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694418 on ClinicalTrials.gov