A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2
Primary Purpose
Trauma and Stressor Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Informed Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Trauma and Stressor Related Disorders
Eligibility Criteria
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
Sites / Locations
- Park High School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
High School Students: Remote Delivery
High School Students: Face-to-Face Delivery
Teachers: Remote Delivery
Arm Description
Outcomes
Primary Outcome Measures
Change in 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, 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
Change in 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.
Change in 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.
Change in 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.
Secondary Outcome Measures
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. A higher score indicates higher resilience.
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). 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.
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 5 point Likert scale ranging from 0 (nothing) to 5 (a great deal). Higher scores indicate higher self-perceptions of self-efficacy.
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). Higher scores indicate a greater severity of sleep disturbance.
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). Higher scores indicate higher levels of traumatic stress in respondents.
Full Information
NCT ID
NCT05844007
First Posted
April 24, 2023
Last Updated
June 13, 2023
Sponsor
Montana State University
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT05844007
Brief Title
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2
Official Title
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
March 8, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma and Stressor Related Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High School Students: Remote Delivery
Arm Type
Experimental
Arm Title
High School Students: Face-to-Face Delivery
Arm Type
Experimental
Arm Title
Teachers: Remote Delivery
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Informed Yoga
Intervention Description
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
Primary Outcome Measure Information:
Title
Change in Salivary Cortisol Levels
Description
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
Time Frame
Week 1 and Week 6
Title
Change in Patient Health Questionnaire
Description
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.
Time Frame
Week 1 and Week 6
Title
Change in Generalized Anxiety Disorder-7 Anxiety Scale
Description
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.
Time Frame
Week 1 and Week 6
Title
Change in Heart Rate Variability
Description
Participants enrolled will have their heart rate data measured by the Biopac BioNomadix PPG & EDA System with Pulse Transduce to determine heart rate variability.
Time Frame
Week 1 and Week 6
Secondary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
Week 1 and Week 6
Title
Professional Quality of Life Index (Pro-QOL)
Description
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.
Time Frame
Week 1 and Week 6
Title
Teachers' Sense of Self-Efficacy (Short Form)
Description
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.
Time Frame
Week 1 and Week 6
Title
PROMIS Sleep Disturbance Scales
Description
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.
Time Frame
Week 1 and Week 6
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Week 1 and Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Adams, MD, Ph.D
Organizational Affiliation
Montana State University
Official's Role
Study Director
Facility Information:
Facility Name
Park High School
City
Livingston
State/Province
Montana
ZIP/Postal Code
59047
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2
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