A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2

Trauma and Stressor Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844007
• Other study ID #: MontanaSUYear4
• Secondary ID: 5P20GM104417
• Status: Completed
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2024
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma and Stressor Related Disorders
• Wounds and Injuries

Intervention

Behavioral:
• Trauma-Informed Yoga
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions

Locations

Country	Name	City	State
United States	Park High School	Livingston	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Cortisol Levels	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	Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6
Primary	Patient Health Questionnaire	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.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Primary	Generalized Anxiety Disorder-7 Anxiety Scale	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.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Primary	Heart Rate Variability	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.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary	Connor-Davidson Resilience Scale (CD-RISC)	The CD-RISC 10 is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum score possible is a 0 and the maximum score is a 40. A higher score indicates an improvement (increased resilience).	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary	Professional Quality of Life Index (Pro-QOL)	Teachers will complete this self-reporting scale consisting of 30 items measuring levels of compassion satisfaction, secondary trauma, and professional burnout. Respondents rate items on a 5 point Likert scale ranging from 0 (never) to 5 (very often). Scores within each subscale were added together to produce a mean for each subscale; subscale means were then averaged together for a total mean score. The minimum score for each subscale is a 0, and the maximum score for each subscale is a 50. Reduced scores indicate an improvement in burnout and secondary trauma.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary	Teachers' Sense of Self-Efficacy (Short Form)	Teachers will complete this self-reporting scale consisting of 12 items measuring levels of self-perceived levels of impact on student engagement, instructional strategies, and classroom management. Respondents rate items on a 9 point Likert scale ranging from 0 (nothing) to 9 (a great deal). The minimum score possible is a 0 and the maximum score is a 90. Subscale scores were averaged together to produce a single mean. Higher mean scores indicate improvements in self-perceptions of self-efficacy.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary	PROMIS Sleep Disturbance Scales	Participants will complete this self-reporting scale consisting of 8 items measuring perceived levels of sleep quality over the previous 7 days. Items are scored on a Likert scale ranging from 1 (not at all) to 5 (very much). The minimum score possible is 8 and the maximum score is a 40. Lower scores indicate an improvement in sleep quality, and higher scores indicate increased severity of sleep disturbances.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary	PTSD Checklist for DSM-5 (PCL-5)	Teachers will complete this self-reporting scale consisting of 20 items measuring traumatic stress symptoms in the previous month. Items are scored on a Likert scale from 0 (not at all) to 4 (extremely). The minimum score possible is a 0 and the maximum score is an 80. Lower scores indicate improvements in traumatic stress symptoms, and higher scores worsening levels of traumatic stress in respondents.	Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6