[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628387":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":37,"locations":44,"responsibleParty":70,"collaborators":72,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":22,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Montana State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NE+ intervention","EXPERIMENTAL",null,[13],"Behavioral: NE+",{"label":15,"type":16,"description":11,"interventionNames":17},"Control","PLACEBO_COMPARATOR",[18],"Behavioral: Control",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BEHAVIORAL","NE+","School-based learning intervention consisting of 18 learning modules taught over 9 months.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.",[15],[29,32,35],{"name":30,"affiliation":5,"role":31},"Elizabeth L Rink, PhD, MSW","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Julie Baldwin, PhD","Northern Arizona University",{"name":36,"affiliation":5,"role":31},"Molly Secor, PhD",[38,42],{"name":30,"role":39,"phone":40,"phoneExt":11,"email":41},"CONTACT","406-600-0297","elizabeth.rink@montana.edu",{"name":36,"role":39,"phone":11,"phoneExt":11,"email":43},"molly.secor@montana.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Fort Peck Community College","RECRUITING","Bozeman","Montana","59715","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-111.03856,45.67965,{"lat":57,"lon":56},[60,64,68],{"name":61,"role":39,"phone":62,"phoneExt":11,"email":63},"Olivia Johnson, MA","406-786-7427","ojohnson@fpcc.edu",{"name":65,"role":39,"phone":66,"phoneExt":11,"email":67},"Ashley Solheim-Azure, AA","(406)480-9389","aazure@fpcc.edu",{"name":69,"role":31,"phone":11,"phoneExt":11,"email":11},"Robyn Baker, MA",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[73,76,77,79],{"name":74,"class":75},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH",{"name":34,"class":6},{"name":78,"class":6},"Mathematica Policy Research, Inc.",{"name":46,"class":80},"UNKNOWN","100628387","nen-nkumbiedahiyedo-plus-we-are-here-now-plus-a-multi-level-intervention-to-reduce-health-disparities-among-american-indian-youth-100628387",false,"NCT07460973","Nen ŨnkUmbi\u002FEdaHiYedo Plus (We Are Here Now Plus): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth","Nen ŨnkUmbi\u002FEdaHiYedo Plus (NE+): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth","Inclusion Criteria:\n\n* 12 to 18 years old\n* Registered member of a federally recognized tribe or an associate tribal member\n* Resident of the Fort Peck Reservation with a caregiver who agrees for their child to participate in the intervention\n\nExclusion Criteria:\n\n* Not meeting any of the aforementioned inclusion criteria\n* 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",true,"ALL","12 Years","18 Years",{"count":93,"type":94},843,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.\n\nYouth 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.\n\nCaregiver (parent) participants will participate in three in-person visits\u002Fmeetings 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\u002FHIV prevention and abstinence from sex, parental monitoring, tribal resources.\n\nSchool 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\u002FHIV prevention, tribal resources; Workshop 3 - culturally respectful communication skills by age \\& youth (boy\u002Fgirl) and age \\& caregiver (male\u002Ffemale); skills - knowledge of cultural ways, substance use prevention, positive mental health promotion, sexual risk avoidant behaviors, culturally respectful communication.",[100,101,102,103],"Healthy","Condom Use","Mental Health","Substance Use (Drugs, Alcohol)",[105,106,107],"Sexual and reproductive health","Mental health","Substance use","2026-05-09",{"date":110,"type":111},"2026-05-12","ACTUAL",{"date":113,"type":111},"2026-03-23",{"date":115,"type":94},"2029-05-01",{"name":5,"class":6},1]