Wakȟáŋyeža (Little Holy One): Enhancing Caregivers' and Children's Well-being Through an Evidence-based and Culturally Informed Prevention Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Aim 1: Change in caregiver trauma symptoms
研究概览
简要总结
The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.
详细描述
The scientific premise of this work is rooted in understanding that high rates of historical and current trauma in Native communities compromise caregivers' mental health and parenting, which in turn affect early childhood behavior problems and adverse events that increase children's risk for suicide and substance use in adolescent and young adulthood.
Wakȟáŋyeža will combine adapted elements of: 1) Common Elements Treatment Approach (CETA), an evidence-based intervention proven effective to reduce stress, depression and trauma-related symptoms, 2) Family Spirit, an evidence-based parent training program to promote positive early child development in Native American communities, and 3) cultural components informed by tribal-specific risk and protective factors for suicide and substance abuse identified in community-based studies that led to this proposal. The intervention will consist of 12 weekly individual lessons taught to parents and children (ages 2 to 5) at Head Start facilities by indigenous community health workers, a delivery strategy selected to enhance participant engagement, local acceptability and sustainability.
This study will use a randomized control trial (RCT) with an embedded single-case experimental design (SCED) to determine the effectiveness of the intervention on mental health and behavioral outcomes among N=120 parent-child dyads, while empirically exploring the added benefit of specific cultural components on parent/caregiver outcomes. The study plan is situated within a well-established trust relationship with tribal communities, innovative formative research that led to this proposal, and an experienced, multi-disciplined study team led by an Indigenous Principle Investigator.
A supplement has been added to this clinical trial, the goal of the supplement is to add to our understanding of opioids and other substance use and suicide risk in Native communities by analyzing individual social network data to understand the relational factors that may increase both risk of suicide and opioid use and the relational characteristics of networks that act as protective factors for suicide and opioid use.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or caregiver of 2-5-year-old child
- •Parent or caregiver must be willing to participate in all aspects of the study including random assignment
- •Parent or caregiver has been exposed to at least 1 adverse childhood event or historical trauma
- •Child is an enrolled member of Fort Peck Tribes or the descent of an enrolled member
排除标准
- •Parent or caregiver is under 18 years of age.
- •Inability to participate in full intervention
研究组 & 干预措施
Little Holy One intervention
The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks.
干预措施: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules (Behavioral)
Nutrition control
The active control condition will receive nutrition information, weekly food boxes and recipes based on seasonal foods, as well as a shopping list for making future meals.
干预措施: Active nutrition control (Behavioral)
结局指标
主要结局
Aim 1: Change in caregiver trauma symptoms
时间窗: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Change in caregiver trauma symptoms will be self-reported using the Post-traumatic stress disorder (PTSD) checklist for the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 (PTSD Checklist for DSM-5, Civilian Version). This is a 20-item questionnaire. Scores range from 0-80. When used clinically a score of 33 or above indicates further assessment is needed.
Aim 1: Change in Caregiver Parenting Stress
时间窗: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Caregiver change in stress symptoms; Self-report that measures three domains of parenting stress: parental distress, parent-child dysfunctional interaction, and difficulty with child. 36-item questionnaire. Scores range from 36-180. Score ranges are represented as percentiles; 15-80 is considered a typical stress percentile, 81-89 is considered a high stress percentile, and 90-100 is considered a clinically significant stress percentile.
次要结局
- Aim 1: Change in Caregiver Depression(Baseline visit, 12 weeks, 12 months)
- Aim 1: Stressful Life Events(Baseline visit)
- Aim 1: Parents' positive childhood experiences(Baseline visit)
- Aim 1: Adverse Childhood Experiences (ACEs)(Baseline visit)
- Aim 1: Parenting practices(Baseline visit, 12 weeks, 12 months)
- Aim 1: Parental control(Baseline visit, 12 weeks, 12 months)
- Aim 1: Family routines(Baseline visit, 12 weeks, 12 months)
- Aim 1: Parent substance use(Baseline visit, 12 weeks, 12 months)
- Aim 1: Parent historical loss experiences(Baseline visit)
- Aim 1: Parental communal mastery(Baseline visit, 12 weeks, 12 months)
- Aim 1: Parent tribal identity(Baseline visit, 12 weeks, 12 months)
- Aim 1: Parental experiences related to historical trauma(Baseline visit)
- Aim 2: Parent stress(Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months)
- Aim 3: Social networks information(Baseline visit, 12 weeks, 12 months)
- Aim 3: Suicide risk(Baseline visit, 12 weeks, 12 months)