Family Spirit Strengths
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 6
- 主要终点
- Difference in number of poor mental health days in last 30 days as assessed by a single item on the Health-Related Quality of Life (HRQOL) measure
研究概览
简要总结
This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identify as female; and
- •Pregnant or be a primary caregiver of a child that is 24 months or younger; and
- •14 years or older at time of enrollment; and
- •Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
- •Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
- •Be part of the service population of one of the participating sites.
排除标准
- •Profound disability that limits the ability to participate in assessments or interventions; and
- •Unlikely to be residing in or near the research service area for the next 6 months.
研究组 & 干预措施
Family Spirit Strengths (FSS)
FSS participants will receive 4-16 (average of 6-8) intervention visits covering topics related to their mental and behavioral health. The number of sessions each participant receives varies and depends on their unique needs. To guide this process, all intervention participants will take a brief, in-session survey to screen for current challenges they may be facing. Their answers will help determine the content and dose of future sessions.
干预措施: Family Spirit Strengths (FSS) (Behavioral)
Family Spirit Nurture
Participants enrolled in nutrition education comparison group will receive 6 educational lessons related to promoting early childhood healthy growth. Lessons will be delivered bi-weekly for no longer than 4-months total. The lessons are from the evidence-based Family Spirit Nurture curriculum.
干预措施: Family Spirit Nurture (Behavioral)
结局指标
主要结局
Difference in number of poor mental health days in last 30 days as assessed by a single item on the Health-Related Quality of Life (HRQOL) measure
时间窗: baseline, 3-4 months post baseline, 6-8 months post baseline
As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-up timepoint.
次要结局
- Change in Substance Use as measure by the Timeline Follow Back for Substance Use(baseline, 3-4 months post baseline, 6-8 months post baseline)
- Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)(baseline, 3-4 months post baseline, 6-8 months post baseline)
- Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form(baseline, 3-6 months post baseline, 6-8 months post baseline)