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

Nen ŨnkUmbi/EdaHiYedo Plus (NE+): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Mental Health; Condom Use; Substance Use (Drugs, Alcohol)
• Intervention / Treatment: Behavioral: NE+; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 843
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth L Rink, PhD, MSW; Phone Number: 406-600-0297; Email: elizabeth.rink@montana.edu
• Study Contact Backup: Name: Molly Secor, PhD; Email: molly.secor@montana.edu

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59715
      • Recruiting
      • Fort Peck Community College
      • Contact: Olivia Johnson, MA; Phone Number: 406-786-7427; Email: ojohnson@fpcc.edu
      • Contact: Ashley Solheim-Azure, AA; Phone Number: (406)480-9389; Email: aazure@fpcc.edu
      • Principal Investigator: Robyn Baker, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 12 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

Exclusion Criteria:

• Not meeting any of the aforementioned inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Behavioral: Control; Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.
Experimental: NE+ intervention	Behavioral: NE+; School-based learning intervention consisting of 18 learning modules taught over 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean condom use self-efficacy score derived from Talashek's Condom Use Self Efficacy Scale	Talashek's condom use self-efficacy scale consists of 6 questions regarding condom use self-efficacy (e.g., "I could get condoms") with likert-type responses ranging from 1-5 (1 Yes, I could; 2 Maybe I could; 3 Don't Know; 4 Probably I could not; 5 No, I could not). Scores from each item will be summed to create a sum score between 5 and 30.	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	One single question asks youth how likely it is that they intend to use a condom the next time they have sex, assessed by a likert-type response set of answers ranging from 1-5, where 1 is the least likely and 5 is the most likely.	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	18 questions from the pathways of choice survey, each with a likert-type response set (1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree) will be summed to create a composite score between 18 and 90.	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	10 questions from the Native STAND survey ask participants if a certain characteristic is representative of a healthy relationship. Participants respond "no" or "yes", where answers of "no" are coded to 0 and "yes" coded to 1. All answers will be summed to create a composite score from 0 to 10.	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	Participants are asked 7 questions pertaining to their confidence in being able to refuse sex in different scenarios. The responses range from 1-5 (1, I Definitely Can Say No; 2, I Can Say No; 3, I Don't Know; 4, I Can't Say No; 5, I Definitely Can't Say No). All responses will be summed to create a composite score ranging from 7 to 35.	From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean score on knowledge of sexually transmitted infections and other sexual health items		From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean caregiver-youth communication score derived from the Parent-Adolescent Communication Scale	Participants are asked 5 questions about how often they speak with their parents about topics regarding sexual health (e.g., "In the past 6 months, how often have you and y our parent(s) talked about how to use condoms?"), where responses range from 0=never, 1=rarely, 2=sometimes, and 3=often. Responses are summed to create a composite score ranging from 0 to 15.	From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean caregiver-adolescent openness score derived from the Parent-adolescent communication scale	Participants are asked 10 questions regarding their openness with their parents (e.g., "I can discuss my beliefs with my mother/father without feeling restrained or embarrassed"), where responses are: 1, Strongly disagree; 2, Somewhat disagree; 3, Neither disagree nor agree; 4, Somewhat agree; 5, Strongly agree. Responses will be summed to create a composite score ranging from 10 to 50.	From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean cultural connectedness score derive from the cultural connectedness scale (short form)	Participants are asked 10 questions regarding how connected they feel to their culture in three different domains (identity, spirituality, and traditions). Response sets include 1=yes and 0=no, as well as likert-type responses (1=strongly disagree, 2=somewhat disagree, 3=neither agree nor disagree, 4=somewhat agree, 5=strongly agree). Responses will be summed to create a composite score for cultural connectedness ranging from 0 to 30.	From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean communication score between youth and school personnel derived from an adapted Ambulatory Care Experiences (ACE) survey.	Participants are asked 8 questions about their communication and relationship with school personnel, with response sets from 1, Strongly disagree; 2, Somewhat disagree; 3, Neither disagree nor agree; 4, Somewhat agree; 5, Strongly agree. Responses will be summed to create a composite score from 8 to 40.	From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

Collaborators and Investigators

• Sponsor: Montana State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Mathematica Policy Research, Inc.; Northern Arizona University; Fort Peck Community College
• Investigators: Principal Investigator: Elizabeth L Rink, PhD, MSW, Montana State University; Principal Investigator: Julie Baldwin, PhD, Northern Arizona University; Principal Investigator: Molly Secor, PhD, Montana State University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mental health; Sexual and reproductive health; Substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Personal Satisfaction; Sexual Behavior; Substance-Related Disorders; Psychological Well-Being; Coitus
• Other Study ID Numbers: R01MD012761-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No