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

Sponsor
Montana State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05844007
Collaborator
(none)
80
1
3
16.1
5

Study Details

Study Description

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 research demonstrates that this intervention is linked to improvements in mental (anxiety and depression) and physical health (cortisol) for students. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trauma-Informed Yoga
N/A

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
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
Actual Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: High School Students: Remote Delivery

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

Experimental: High School Students: Face-to-Face Delivery

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

Experimental: Teachers: Remote Delivery

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

Outcome Measures

Primary Outcome Measures

  1. Change in Salivary Cortisol Levels [Week 1 and 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, halfway through the intervention, and on the last day of the intervention 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

  2. Change in Patient Health Questionnaire [Week 1 and 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.

  3. Change in Generalized Anxiety Disorder-7 Anxiety Scale [Week 1 and 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.

  4. Change in Heart Rate Variability [Week 1 and 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.

Secondary Outcome Measures

  1. Connor-Davidson Resilience Scale (CD-RISC) [Week 1 and Week 6]

    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. A higher score indicates higher resilience.

  2. Professional Quality of Life Index (Pro-QOL) [Week 1 and Week 6]

    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). Higher scores on compassion satisfaction items indicate higher levels of job enjoyment, whereas higher scores on burnout and secondary trauma items indicate lower levels of job satisfaction.

  3. Teachers' Sense of Self-Efficacy (Short Form) [Week 1 and Week 6]

    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 5 point Likert scale ranging from 0 (nothing) to 5 (a great deal). Higher scores indicate higher self-perceptions of self-efficacy.

  4. PROMIS Sleep Disturbance Scales [Week 1 and Week 6]

    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). Higher scores indicate a greater severity of sleep disturbance.

  5. PTSD Checklist for DSM-5 (PCL-5) [Week 1 and Week 6]

    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). Higher scores indicate higher levels of traumatic stress in respondents.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 85 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Park High School Livingston Montana United States 59047

Sponsors and Collaborators

  • Montana State University

Investigators

  • Study Director: Alexandra Adams, MD, Ph.D, Montana State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montana State University
ClinicalTrials.gov Identifier:
NCT05844007
Other Study ID Numbers:
  • MontanaSUYear4
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023