HealthyNE+NCT07460973
Nen ŨnkUmbi/EdaHiYedo Plus (We Are Here Now Plus): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth
A study testing NE+ in people with Healthy and Condom Use, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Condom Use, Mental Health
- What is being tested?
- NE+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 843 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Molly Secor, PhD contact
United States1 site, 1 recruiting
- Recruiting
Fort Peck Community College
Bozeman, Montana, 59715
Olivia Johnson, MA, 406-786-7427, ojohnson@fpcc.edu
Ashley Solheim-Azure, AA, (406)480-9389, aazure@fpcc.edu
About this study
Official title: 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.
Read more
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)
- Being tested
- NE+, Control
- Keywords
- Sexual and reproductive health, Mental health, Substance use
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NE+Behavioural
School-based learning intervention consisting of 18 learning modules taught over 9 months.
ControlBehavioural
Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.
| Study group | Role | What they receive |
|---|---|---|
| NE+ intervention | Experimental | Not described Receives: Behavioral: NE+ |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean depressive symptoms score
Measured: 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
Measured: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean anxiety score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start23 Mar 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 843 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Northern Arizona University, Mathematica Policy Research, Inc., Fort Peck Community College
- Responsible party
- Sponsor
- Investigators
- Elizabeth L Rink, PhD, MSW, Principal investigator, Montana State UniversityJulie Baldwin, PhD, Principal investigator, Northern Arizona UniversityMolly Secor, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460973
- Sponsor's protocol ID
- R01MD012761-07
- Other IDs
- R01MD012761-07
- Acronym
- NE+
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nen ŨnkUmbi/EdaHiYedo Plus (NE+): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth
- ClinicalTrials.gov ID
- NCT07460973
- Acronym / sponsor ID
- NE+ / R01MD012761-07
- Conditions
- Healthy, Condom Use, Mental Health, Substance Use (Drugs, Alcohol)
- Keywords
- Sexual and reproductive health, Mental health, Substance use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 843 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Northern Arizona University, Mathematica Policy Research, Inc., Fort Peck Community College
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NE+ intervention | Experimental | Behavioral: NE+ |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NE+School-based learning intervention consisting of 18 learning modules taught over 9 months. | Behavioural | NE+ intervention |
| ControlParticipants will not receive any educational material in this arm and will only provide survey responses to act as control observations. | Behavioural | Control |
Primary outcome
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
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.
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
10 secondary outcomes
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
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
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
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
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
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
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
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)
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.
Time frame: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Molly Secor, PhD contact
Elizabeth L Rink, PhD, MSW principal investigator
Montana State University
Julie Baldwin, PhD principal investigator
Northern Arizona University
Molly Secor, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NE+ in people with Healthy and Condom Use, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth L Rink, PhD, MSW (406-600-0297, elizabeth.rink@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.