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临床试验/NCT05844007
NCT05844007已完成不适用

A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana

Montana State University2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
Patient Health Questionnaire

研究概览

简要总结

Compared to U.S. urban counterparts, rural residents face major barriers to using health care services. Challenges include shortages of services, long distances to existing services, and stigma regarding mental illness in isolated communities. These difficulties hold true for Montana, but especially for adolescents. The objective of A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana is to improve stress-related mental and physical health outcomes for adolescents and educators in rural Montana through school-based, trauma-informed yoga exercises. This project builds on investigators' previous research (including a two-year CAIRHE pilot study, 2019-21) to promote positive youth development by simultaneously intervening with students and teachers with a trauma-informed yoga intervention. Geographic isolation and resulting lack of resources for many Montanan schools indicates a need for novel, school-centered interventions to address the needs of rural adolescents; yoga can benefit youth and teacher wellbeing.

详细描述

In Year 2, investigators will expand the study to pilot test a remote delivery for students and teachers in rural schools through virtual delivery (in addition to an in-person high school student intervention at the school district of Aim 1. Primary outcomes for teachers will assess career satisfaction/self-efficacy; primary outcomes for students will assess depression/anxiety symptomology. Effects on secondary mental/physical health outcomes will be drawn from survey results, cortisol levels, and heart rate variability measures (collected pre/post).

Investigators will then determine which intervention design was more effective with students (in-person vs. remote) between the two years of this feasibility study through an outcome evaluation. Comparisons of mental and physical health outcomes will be examined by the research team using cohort data drawn from participants' physiological data and survey results.

The short-term public health impact of this study is to improve the mental and physical health of rural Montana youth and teachers through a novel, school-based intervention. If successful, this study's long-term public health impact will reduce rates of anxiety and depression and improve physical health in geographically isolated settings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any teacher currently employed by the Livingston or Gardiner school district who wishes to participate in the intervention (up to 45 participants)
  • Any freshmen student enrolled in pre-selected PE classes at Park High School in Livingston Montana
  • Any PE student enrolled in pre-selected PE classes at Gardiner High School in Gardiner Montana

排除标准

  • Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana

结局指标

主要结局

Patient Health Questionnaire

时间窗: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

This 9 item questionnaire is designed to evaluate severity of depressive symptoms in participants. It is scored on a Likert scale from 0 (not at all) to 3 (nearly every day) on items linked to depression indicators. The minimum score is a 0 and the maximum score is a 27, and a reduction in score from pre- to post-assessment indicates an improvement in symptomology.

Generalized Anxiety Disorder-7 Anxiety Scale

时间窗: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

This 7 item questionnaire is based on a likert scale of 0 (not at all) to 3 (nearly every day) for items related to anxiety disorders. The lowest score is a zero and the maximum score is a 21. A reduction in score from pre- to post-assessment indicates an improvement in symptomology.

Salivary Cortisol Levels

时间窗: Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6

Participants will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention (week 1) and on the last day of the intervention (week 6) to determine if the intervention has improved stress levels (as indicated by a reduction in cortisol levels). A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study

Heart Rate Variability

时间窗: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

Participants enrolled will have their heart rate data measured by the Biopac BioNomadix PPG \& EDA System with Pulse Transduce to determine heart rate variability. Due to circumstances beyond the research team's control, only teachers at one study site were able to provide heart rate variability data, so fewer than our total enrollment was able to provide this data.

次要结局

  • Professional Quality of Life Index (Pro-QOL)(Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6)
  • Connor-Davidson Resilience Scale (CD-RISC)(Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6)
  • Teachers' Sense of Self-Efficacy (Short Form)(Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6)
  • PROMIS Sleep Disturbance Scales(Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6)
  • PTSD Checklist for DSM-5 (PCL-5)(Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Davis

Assistant Professor

Montana State University

研究点 (2)

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