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NCT Number: NCT07460973

Nen ŨnkUmbi/EdaHiYedo Plus (We Are Here Now Plus): 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.

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Key information

Conditions

Healthy Behavior Chemically-Induced Disorders Coitus Condom Use Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being Sexual Behavior Substance Use (Drugs, Alcohol) Substance-Related Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  4. Change from baseline in mean number of lifetime sex partners

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  8. Change from baseline in mean depressive symptoms score

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  10. Change from baseline in mean anxiety score

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  11. Change from baseline in mean age of youth initiating tobacco use

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  34. 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)

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

Secondary outcomes

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

  2. 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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

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

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

  6. Change from baseline in mean score on knowledge of sexually transmitted infections and other sexual health items

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

  7. Change from baseline in mean caregiver-youth communication score derived from the Parent-Adolescent Communication Scale

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

  8. Change from baseline in mean caregiver-adolescent openness score derived from the Parent-adolescent communication scale

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

  9. Change from baseline in mean cultural connectedness score derive from the cultural connectedness scale (short form)

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

  10. Change from baseline in mean communication score between youth and school personnel derived from an adapted Ambulatory Care Experiences (ACE) survey.

    Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth L Rink, PhD, MSW

CONTACT

[email protected]

406-600-0297

Molly Secor, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NE+

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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