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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM104417 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High School Students: Remote Delivery | Experimental | Remote delivery of trauma-informed yoga session for high school students |
|
| High School Students: Face-to-Face Delivery | Experimental | Face-to-face delivery of trauma-informed yoga session for high school students |
|
| Teachers: Remote Delivery | Experimental | Remote delivery of trauma-informed yoga session for teachers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-Informed Yoga | Behavioral | Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Adams, MD, Ph.D | Montana State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park High School | Livingston | Montana | 59047 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High School Students: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| FG001 | High School Students: Face-to-Face Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| FG002 | Teachers: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High School Students: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| BG001 | High School Students: Face-to-Face Delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | micrograms per deciliter | Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High School Students: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Davis | Montana State University | 828-773-6328 | lauren.davis6@montana.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | Feb 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Jan 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 |
| 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 |
| 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 |
| 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 |
| 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 |
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| BG002 | Teachers: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cortisol Levels | Mean | Standard Deviation | micrograms per deciliter |
|
| High School Students: Face-to-Face Delivery |
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
| OG002 | Teachers: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | High School Students: Face-to-Face Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Teachers: Remote Delivery | Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | 0 | 43 | 0 | 43 | 0 | 43 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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