An interventional study of NE+ and Control in Healthy, Condom Use and Mental Health, sponsored by Montana State University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Montana State University · Not applicable, Interventional, and Prevention
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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 843 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Montana State University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Compared within Psychological Well-Being, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Behavioral: NE+
Behavioral: Control
School-based learning intervention consisting of 18 learning modules taught over 9 months.
Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.
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
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for May 2029, 37 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 37 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
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Montana State University