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Clinical Trials/NCT05844007
NCT05844007CompletedNot Applicable

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

Montana State University1 site in 1 country83 target enrollmentStarted: January 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
83
Locations
1
Primary Endpoint
Patient Health Questionnaire

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
13 Years to 85 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

High School Students: Remote Delivery

Experimental

Remote delivery of trauma-informed yoga session for high school students

Intervention: Trauma-Informed Yoga (Behavioral)

High School Students: Face-to-Face Delivery

Experimental

Face-to-face delivery of trauma-informed yoga session for high school students

Intervention: Trauma-Informed Yoga (Behavioral)

Teachers: Remote Delivery

Experimental

Remote delivery of trauma-informed yoga session for teachers

Intervention: Trauma-Informed Yoga (Behavioral)

Outcomes

Primary Outcomes

Patient Health Questionnaire

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lauren Davis

Assistant Professor

Montana State University

Study Sites (1)

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