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

Официальное название

Nen ŨnkUmbi/EdaHiYedo Plus (NE+): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth

Обзор

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.

Вмешательства

• Поведенческое NE+
  School-based learning intervention consisting of 18 learning modules taught over 9 months.
• Поведенческое Control
  Participants will not receive any educational material in this arm and will only provide survey responses to act as control observations.

Первичные конечные точки

• Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline]
• Change from baseline in mean depressive symptoms score [Срок оценки: 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 [Срок оценки: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline]
• Change from baseline in mean anxiety score [Срок оценки: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline]

Вторичные конечные точки (10)

• Change from baseline in mean condom use self-efficacy score derived from Talashek's Condom Use Self Efficacy Scale [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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. [Срок оценки: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Fort Peck Community College — Bozeman

Идентификаторы

NCT: NCT07460973 · R01MD012761-07 · R01MD012761-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗