Nen ŨnkUmbi/EdaHiYedo Plus (NE+): a Multi-level Intervention to Reduce Health Disparities Among American Indian Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 843
- 试验地点
- 1
- 主要终点
- Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NE+ intervention
干预措施: NE+ (Behavioral)
Control
干预措施: Control (Behavioral)
结局指标
主要结局
Change from baseline in mean condom use frequency relative to sexual intercourse frequency in the past month
时间窗: 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
时间窗: 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 number of lifetime sex partners
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean depressive symptoms score
时间窗: 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
时间窗: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
Change from baseline in mean anxiety score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline
次要结局
- Change from baseline in mean condom use self-efficacy score derived from Talashek's Condom Use Self Efficacy Scale(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(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(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(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(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(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(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(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)(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.(From baseline to 9 months post-baseline, 14 months post-baseline, and 26 months post-baseline)