Nen ŨnkUmbi/EdaHiYedo Plus (We Are Here Now Plus): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMontana State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

843 Participants
are divided into 2 treatment groups
Group A: NE+ interventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

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

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
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

Secondary outcomes

1

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
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

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montana State University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Northern Arizona University

Collaborator

Mathematica Policy Research, Inc.

Collaborator

Fort Peck Community College

Collaborator