Recruiting

NE+ Intervention

Sponsor:

Montana State University

Code:

NCT07460973

Conditions

Healthy

Condom Use

Mental Health

Substance Use (Drugs, Alcohol)

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

NE+

Control

Study Details

Brief summary:

We Are Here Now - Plus (NE+) is a holistic, culturally centered, and multilevel intervention for American Indian youth to improve sexual health, mental health, and substance use outcomes. The goal of this intervention is to learn if NE+ can decrease substance use during sex, decrease sexual activity, increase condom use, increase positive mental health, increase caregiver(parent)-youth communication, increase communication between school personnel and youth, and increase utilization of clinical services. Researchers will compare one intervention arm to one control arm to see if the aforementioned indicators improve among the intervention arm for youth participants.

Youth participants (ages 12-18) will participate in a 9-month educational program consisting of 18 modules that discuss healthy relationships, puberty \& physiology (separate girls \& boys), parenting, pregnancy and sexually transmitted infections (STIs) and Human Immunodeficiency Virus (HIV) prevention, sexual avoidant behaviors with a focus on abstinence, substance use prevention with a focus on abstinence and refusal skills, \& positive mental health, resources; skills (high school)- self-efficacy, refusal skills, decision making, communication, abstinence; skills (middle school) - health knowledge, self-efficacy, boundaries, communication, abstinence. Youth will also participate in six teachings offered by local cultural leaders that coincide with educational modules, including: kinship networks \& family; cultural values; 7 sacred roles of tribal members; ceremonies; cultural teachings and responsibilities of women \& men in tribe \& ceremonies; Indigenous worldview; skills - knowledge of traditional ways, language \& cultural people to go to for help; community members roles \& responsibilities in tribe \& ceremonies.

Caregiver (parent) participants will participate in three in-person visits/meetings to discuss the following: visit 1 - age specific physical, cognitive, emotional, spiritual development; visit 2: prevention of substance use, promoting positive mental health, promotion of healthy relationships; skills -communication with youth; visit 3 - pregnancy and STIs/HIV prevention and abstinence from sex, parental monitoring, tribal resources.

School personnel participants will participate in three workshops during teacher in-service training days, including the following information: Workshop 1 - cultural teachings on kinship \& family networks, cultural values, cultural age \& community roles; Workshop 2 - sexual risk avoidant behaviors, substance use prevention, positive mental health promotion, pregnancy STIs/HIV prevention, tribal resources; Workshop 3 - culturally respectful communication skills by age \& youth (boy/girl) and age \& caregiver (male/female); skills - knowledge of cultural ways, substance use prevention, positive mental health promotion, sexual risk avoidant behaviors, culturally respectful communication.

Conditions

Healthy

Condom Use

Mental Health

Substance Use (Drugs, Alcohol)

Study ID

NCT07460973

Start date

Mar 23, 2026

Status verified date

May, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

843 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: NE+ intervention

placebo comparator: Control

Interventions

NE+

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

Control

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

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Elizabeth L Rink, PhD, MSW

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

Molly Secor, PhD

molly.secor@montana.edu

Locations

Fort Peck Community College

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Olivia Johnson, MA

406-786-7427ojohnson@fpcc.edu

Ashley Solheim-Azure, AA

(406)480-9389aazure@fpcc.edu

Principal Investigator:

Robyn Baker, MA

More Information

Sponsor

Montana State University

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Sexual and reproductive health
  • Mental health
  • Substance use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montana State University on 2026-05-12.