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

NCT07460973 | Recruiting DMC

• 1 other identifier: R01MD012761-07
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Sexual and reproductive health; Mental health; Substance use

Outcome Measures

Primary Outcomes (37)

• Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of participants reporting if they have ever had sexual intercourse

  Measuring the mean number of youth who report having ever had sex to examine if youth in the intervention arm have less initiation of sexual intercourse compared to youth in control arm.

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean age when participants first engage in sexual intercourse

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of lifetime sex partners

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of recent (past-month) sex partners

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times participants recently (in the past month) engaged in sexual intercourse

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times birth control was used during sexual intercourse

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean depressive symptoms score

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change in baseline in mean number of youth who have ever smoked a cigarette

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean anxiety score

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean age of youth initiating tobacco use

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of days (of past 30 days) youth reported smoking cigarettes

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of youth who reported ever using an electronic vapor product

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times injection drugs were used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times injection drugs were used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times hallucinogenic drugs were used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times ecstasy was used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times methamphetamines were used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times heroin was used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times glue, aerosol spray, or other inhalants were used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times cocaine was used in past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times hallucinogenic drugs (e.g., acid) were used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times ecstasy was used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times methamphetamines were used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times heroin was used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times glue, aerosol spray, or other inhalants were used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times any form of cocaine has been used in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times prescription pain medicine without doctor's prescription was used in the past 30 days

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times prescription pain medicine was used without a doctor's prescription in lifetime

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times in the past 30 days youth reported using marijuana

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean age at which youth reported first using marijuana for the first time

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of times youth reported using marijuana in their life

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of drinks (in the past 30 days) that youth reported having in a row

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of days (in past 30 days) youth reported having 4 or more drinks of alcohol in a row (for males) or 5 or more drinks of alcohol in a row (for females)

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of days (in past 30 days) youth reported having at least one drink of alcohol

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in the mean age at which youth reported having alcohol for the first time

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean number of days (in past 30 days) youth reported using an electronic vapor product

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

Secondary Outcomes (10)

• Change from baseline in mean condom use self-efficacy score derived from Talashek's Condom Use Self Efficacy Scale

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean condom use intention score derived from one question with a likert-type response set from the Youth Health Risk Behavioral Inventory

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean beliefs about birth control score from the pathways of choice survey

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean score of knowledge of healthy relationships from the Native STAND (students together against negative decisions) survey

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

• Change from baseline in mean sexual refusal score derived from a sexual refusal scale from the sexual refusal skills regarding sex

  From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

Study Arms (2)

NE+ intervention

EXPERIMENTAL

Behavioral: NE+

Control

PLACEBO COMPARATOR

Behavioral: Control

Interventions

NE+ BEHAVIORAL

School-based learning intervention consisting of 18 learning modules taught over 9 months.

NE+ intervention

Control BEHAVIORAL

Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 18 years old
• Registered member of a federally recognized tribe or an associate tribal member
• Resident of the Fort Peck Reservation with a caregiver who agrees for their child to participate in the intervention

You may not qualify if:

• Having a medically identified physical or cognitive impairment that would impede their understanding of and participation in the educational content, activities, and teachings of the intervention

Sponsors & Collaborators

• Montana State University: lead
• Northern Arizona University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Mathematica Policy Research, Inc.: collaborator
• Fort Peck Community College: collaborator

Study Sites (1)

Fort Peck Community College

Bozeman, Montana, 59715, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders; Coitus

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders; Sexual Behavior

Study Officials

• Elizabeth L Rink, PhD, MSW

  Montana State University

  PRINCIPAL INVESTIGATOR

• Julie Baldwin, PhD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

• Molly Secor, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth L Rink, PhD, MSW

CONTACT

406-600-0297; elizabeth.rink@montana.edu

Molly Secor, PhD

CONTACT

molly.secor@montana.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)