Nen ŨnkUmbi/EdaHiYedo Plus (We Are Here Now Plus): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth

Part of paid clinical trials in Bozeman, Montana.

Sponsor
Montana State University
Study ID
NCT07460973
Status
Recruiting
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Conditions

  • Condom Use
  • Healthy
  • Mental Health
  • Substance Use (Drugs, Alcohol)

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • NE+ — BEHAVIORAL
    School-based learning intervention consisting of 18 learning modules taught over 9 months.
  • Control — BEHAVIORAL
    Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.

Study Details

We Are Here Now - Plus (NE+) is a holistic, culturally centered, and multilevel intervention for American Indian youth to improve sexual health, mental health, and substance use outcomes. The goal of this intervention is to learn if NE+ can decrease substance use during sex, decrease sexual activity, increase condom use, increase positive mental health, increase caregiver(parent)-youth communication, increase communication between school personnel and youth, and increase utilization of clinical services. Researchers will compare one intervention arm to one control arm to see if the aforementioned indicators improve among the intervention arm for youth participants. Youth participants (ages 12-18) will participate in a 9-month educational program consisting of 18 modules that discuss healthy relationships, puberty \& physiology (separate girls \& boys), parenting, pregnancy and sexually transmitted infections (STIs) and Human Immunodeficiency Virus (HIV) prevention, sexual avoidant behaviors with a focus on abstinence, substance use prevention with a focus on abstinence and refusal skills, \& positive mental health, resources; skills (high school)- self-efficacy, refusal skills, decision making, communication, abstinence; skills (middle school) - health knowledge, self-efficacy, boundaries, communication, abstinence. Youth will also participate in six teachings offered by local cultural leaders that coincide with educational modules, including: kinship networks \& family; cultural values; 7 sacred roles of tribal members; ceremonies; cultural teachings and responsibilities of women \& men in tribe \& ceremonies; Indigenous worldview; skills - knowledge of traditional ways, language \& cultural people to go to for help; community members roles \& responsibilities in tribe \& ceremonies. Caregiver (parent) participants will participate in three in-person visits/meetings to discuss the following: visit 1 - age specific physical, cognitive, emotional, spiritual development; visit 2: prevention of substance use, promoting positive mental health, promotion of healthy relationships; skills -communication with youth; visit 3 - pregnancy and STIs/HIV prevention and abstinence from sex, parental monitoring, tribal resources. School personnel participants will participate in three workshops during teacher in-service training days, including the following information: Workshop 1 - cultural teachings on kinship \& family networks, cultural values, cultural age \& community roles; Workshop 2 - sexual risk avoidant behaviors, substance use prevention, positive mental health promotion, pregnancy STIs/HIV prevention, tribal resources; Workshop 3 - culturally respectful communication skills by age \& youth (boy/girl) and age \& caregiver (male/female); skills - knowledge of cultural ways, substance use prevention, positive mental health promotion, sexual risk avoidant behaviors, culturally respectful communication.

Key Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
843 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: NE+ intervention
  • Placebo Comparator: Control

Primary Outcome Measure

Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month [ Time Frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fort Peck Community CollegeBozemanMontana59715
Olivia Johnson, MA
[email protected]
406-786-7427
Ashley Solheim-Azure, AA
[email protected]
(406)480-9389
Robyn Baker, MA (PRINCIPAL_INVESTIGATOR)

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Fort Peck Community College· Bozeman, MT

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