Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 4
- 主要终点
- Change in youth reported monitoring
研究概览
简要总结
The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female adolescents and their female caregivers. Specifically, investigators aim to evaluate the impact of "Asdzaan Be'eena'" or Female Pathways in English (henceforth referred to as AB) on risk and protective factors for early substance use and sexual debut through a randomized controlled trial (RCT) in partnership with the Navajo Nation. The program was developed and pilot tested through an extensive formative phase conducted by our tribal-academic partnership (IRB protocols: #00006569 and #00009117). Investigators will examine the efficacy of the AB program for reducing risk factors and improving protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.
详细描述
American Indian/Alaska Native(AI/AN) communities contend with high rates of poverty and unemployment, as well as historical trauma and adverse events resulting in poor health outcomes and health disparities across their life course. AI youth adolescents are particularly impacted by these health disparities. They are more likely to be sexually active, have their first sexual intercourse at a young age and have higher rates of teen pregnancy and repeat teen pregnancy than other racial/ethnic groups. In 2016, the birth rate for AI/AN teen girls (age 15-19) was 35 per 1,000, well above the national birth rate of 20.3 per 1,000.
Teen pregnancy may lead to lower educational attainment and is associated with a lower annual income for the mother. Nationally, only about 63% of teen mothers obtain a high school diploma and just 2% earn a college degree. Furthermore, studies have found that decades after becoming a parent, teen mothers have lower annual incomes than women who wait to become mothers. The consequences of teen pregnancy continue generations later. Babies born as result of a teen pregnancy are more likely to be premature and of low birth weight, raising their risk for other health problems including blindness, deafness, chronic respiratory problems, mental illness and mental retardation. Children of teen parents are more likely to live in poverty, drop out of high school and themselves become teen parents. The poverty rate for children born to teenage mothers who never married and who did not graduate from high school is 78% (compared to 9% of children born to women over age 20 who are currently married and did graduate from high school).
Compounding teen pregnancy, AI/ANs have the highest substance use and related morbidity and mortality of any U.S. racial group and are more likely to initiate drug and alcohol use before the age of 13. In AI communities, girls and boys have distinct patterns and processes for underage substance use that leads to early initiation of sex and sexual risk-taking. Among AIs, girls are more likely than boys to use substances during adolescence due to poor self-esteem or self-identity. Girls are also more likely than boys to be offered substances in private settings by female relatives. Additionally, poor attachment to parents is a stronger risk factor for substance use among girls than boys. Thus, gender-specific approaches are needed for optimal prevention of adolescent substance use in AI communities.
An intervention that works with AI females together with their female caregivers and incorporates AI cultural strengths and traditions, while also helping girls grow their ethnic identity and self-esteem may prove efficacious in preventing teen pregnancy, reducing early initiation of substance use and progression to misuse, and improving the health and well being of AI girls and families. The Navajo Nation and Johns Hopkins (JHU) have a long-standing history of addressing AI health disparities through culturally tailored and community-engaged programming and are poised to conduct the RCT described herein.
Investigators will evaluate the intervention: "Asdzaan Be'eena: Female Pathways" (AB). The program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. Five of the 11 sessions will be taught to groups of 9-13 girls and their female caregivers, and 6 of the sessions will be taught to individual girl/female caregiver dyads. The choice to use a mix of group- and individual sessions is based on findings from the formative phase indicating certain topics should be taught in groups (e.g. Navajo history and reproductive health 101), and certain topics be taught in individual dyads (e.g. family values and the clan system).
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
- 10 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in youth reported monitoring
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in youth reported monitoring from baseline and 6- and 12- months post program completion via a 5-item parental monitoring assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.
Change in parent reported parent-youth communication scale
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in parent reported parent-youth communication from baseline and 6- and 12- months post program completion via an 8-item communication assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.
Change in proportion of youth who state they plan to engage in sexual intercourse while they are a teenager
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in proportion of youth who report they intend to have sexual intercourse when they are a teenager between individuals randomized to the AB program vs. those randomized to the control condition. Proportions will be measured from baseline to 6- and 12-months post program completion via one question. This is completed by the child (0-No; 1- Yes). A higher proportion indicates more youth intend to have sex when they are a teenager. A higher proportion indicates a worse outcome.
Change in mean score on externalizing and internalizing behaviors
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in internalizing and externalizing behaviors between individuals randomized to the AB program vs. those randomized to the control condition. Change in internalizing/externalizing behaviors will be measured via the Achenbach System of Empirically Based Assessment (ASEBA) completed by the caregiver (reporting on child behaviors) (3-point Likert Scale \[0-not true; 2-very true\]). A higher score across these variables indicates a worse outcome (i.e. higher (more) internalizing and externalizing behaviors).
Change in youth reported parent-youth communication scale
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in youth reported parent-youth communication from baseline and 6- and 12- months post program completion via 9-item communication assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.
Change in youth reported parental responsiveness
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in youth reported parental responsiveness from baseline and 6- and 12- months post program completion via a 5-item authoritative parenting index (4-point Likert scale \[0-Not at all like her; 3- Just Like her). A higher score indicates a better outcome.
Change in parent reported parental responsiveness
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in parent reported parental responsiveness from baseline and 6- and 12- months post program completion via a 5-item authoritative parenting index (4-point Likert scale \[0-Not at all like her; 3- Just Like her). A higher score indicates a better outcome.
Change in proportion of youth who state they plan to delay having sexual intercourse until they graduate from high school
时间窗: Baseline, 6- and 12-months post implementation
Change in proportion of youth who report they intend to delay sexual intercourse until they graduate from high school between individuals randomized to the AB program vs. those randomized to the control condition. Proportions will be measured from baseline to 6- and 12-months post program completion via one question. This is completed by the child (0-No; 1-Yes). A higher proportion indicates more youth intend to abstain from sex.
Change in parent reported monitoring
时间窗: Baseline, 6- and 12-months post implementation
Investigators will measure change in parent reported monitoring from baseline and 6- and 12- months post program completion via a 9-item parental monitoring assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.
次要结局
- Change in caregiver parenting self-efficacy(Baseline, 6- and 12-months post implementation)
- Change in mean score on healthy relationship skills(Baseline, 6- and 12-months post implementation)
- Change in in youth future aspirations(Baseline, 6- and 12-months post implementation)
- Change in youth sexual initiation(Baseline, 6- and 12-months post implementation)
- Change in parental attitudes and expectations related to substance use and sexual intercourse(Baseline and 6- and 12-months post implementation)
- Change in caregiver parenting agency(Baseline and 6- and 12-months post implementation)
- Change in youth cultural connectedness(Baseline, 6- and 12-months post implementation)
- Change in caregiver cultural connectedness(Baseline and 6- and 12-months post implementation)
- Change in proportion on youth substance use initiation(Baseline, 6- and 12-months post implementation)
- Change in family environment and functioning(Baseline and 6- and 12-months post implementation)
- Change in sexual activity, past 3 months(Baseline and 6- and 12-months post implementation)
- Change in youth reported substance use, past 3 months(Baseline and 6- and 12-months post implementation)
- Change in proportion of caregivers reporting substance use in the past 3 months(Baseline and 6- and 12-months post implementation)