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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM104417 | 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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"A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana" is intended to help mitigate stressors that may contribute to poor behavioral and mental health in rural Montana teachers. The immediate goals of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.
Project Summary: "A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana" is intended to help mitigate stressors that may contribute to poor behavioral and mental health in rural Montana teachers. The immediate goal of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.
Specific Aim: Expansion of previous pilot study to teachers in the southwestern Montana school district.
Methods: To explore scalability to rural communities without access to yoga instructors, we will implement a limited feasibility study of online yoga delivery to classroom teachers. This study will enroll a minimum 30 Livingston teachers (taught trauma-informed yoga via Zoom), twice weekly for 45-minute trauma-informed yoga sessions during the 6-week intervention period. No participants were assigned to the "No Intervention" arm. To measure physical health outcomes, pre, mid-, and post-intervention cortisol testing will be utilized to evaluate any changes in teacher stress levels before and after the program. Heart rate variability will also be assessed for teachers pre, mid-, and post-intervention using the HeartMath Inner Balance PPG sensor and Em Wave Pro Plus software. To assess behavioral health, pre- and post-survey instruments will collect targeted wellness/mental health data from teachers. An Adverse Childhood Experience Self-Reporting Screener will also be given to participants to establish a baseline of exposure to childhood trauma, which is closely correlated with health outcomes. Teachers will also complete the Teachers' Sense of Self Efficacy Survey and the Professional Quality of Life Index, which are linked to teacher mental health, retention, and career satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group Yoga | Experimental | 35 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention |
|
| No Intervention | No Intervention | No participants were assigned to the No Intervention Arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-Informed Yoga | Behavioral | 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Patient Health Questionnaire (PHQ-9) | 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. Lower scores indicate a better outcome. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Generalized Anxiety Disorder-7 Anxiety Scale (GAD-7) | 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. Lower scores indicate a better outcome. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Heart Rate Variability | Participants enrolled will have their heart rate data measured by the HeartMath Institute Inner Balance Bluetooth Sensor and accompanying software for Android or IOS smartphones (Inner Balance) or Inner Balance USB Sensor and accompanying computer software (EmWave Pro Plus (28, 29) The small plastic sensors will clip to the participant's earlobe and send photoplethysmography-derived (PPG) pulse signals via a non-invasive light source and photodetector. |
| Measure | Description | Time Frame |
|---|---|---|
| Connor-Davidson Resilience Scale (CD-RISC) | The Connor Davidson Resilience Scale (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 value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome. |
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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 | Experimental Group Yoga | 20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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20 educators in a rural southwestern Montana school district
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group Yoga | 20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session |
| 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 | 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 | 20 educators in a southwestern Montana school district | Posted | Mean | Standard Deviation | ug/dl | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
6 weeks
No adverse events occurred.
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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 | Experimental Group Yoga | 20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Davis | Montana State University | 8287736328 | laure.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 | May 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Apr 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Professional Quality of Life Index (Pro-QOL) | The Professional Quality of Life Index (Pro-QOL) is 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). The minimum score for each subscale is a 10, and the maximum score for each subscale is a 50. 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. For each of the sub-scales scores are categorized as Low (22 or less), Moderate (between 23 and 41) or High (42 or more). A total sum of each sub-scale is not intended to be measured. Higher scores on the compassion satisfaction scale indicate a better outcome. Lower scores on burnout and secondary trauma indicate a better outcome. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Teachers' Sense of Self-Efficacy (Short Form) (TSSE) | The Teachers' Sense of Self-Efficacy is a 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 1 (nothing) to 9 (a great deal). Higher scores indicate higher self-perceptions of self-efficacy. Higher scores indicate a better outcome. A minimum score isa 12, and a maximum score of 108 is possible on the scale. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| PROMIS Sleep Disturbance Scales (PROMIS) | The PROMIS Sleep Disturbance Scale is 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. The scale's minimum score is an 8, and the scale's maximum score is 40; therefore, lower scores indicate better quality of sleep. Lower scores indicate a better outcome. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a 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. The scale's minimum score is a zero with a maximum score being an 80. Therefore, lower scores indicate an improvement in traumatic stress symptomology. Lower scores indicate a better outcome. | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Cortisol Level | Mean | Standard Deviation | micrograms per deciliter |
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| Primary | Patient Health Questionnaire (PHQ-9) | 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. Lower scores indicate a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
|
| Primary | Generalized Anxiety Disorder-7 Anxiety Scale (GAD-7) | 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. Lower scores indicate a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
|
| Primary | Heart Rate Variability | Participants enrolled will have their heart rate data measured by the HeartMath Institute Inner Balance Bluetooth Sensor and accompanying software for Android or IOS smartphones (Inner Balance) or Inner Balance USB Sensor and accompanying computer software (EmWave Pro Plus (28, 29) The small plastic sensors will clip to the participant's earlobe and send photoplethysmography-derived (PPG) pulse signals via a non-invasive light source and photodetector. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | beats per minute (bpm) | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
|
| Secondary | Connor-Davidson Resilience Scale (CD-RISC) | The Connor Davidson Resilience Scale (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 value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
|
| Secondary | Professional Quality of Life Index (Pro-QOL) | The Professional Quality of Life Index (Pro-QOL) is 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). The minimum score for each subscale is a 10, and the maximum score for each subscale is a 50. 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. For each of the sub-scales scores are categorized as Low (22 or less), Moderate (between 23 and 41) or High (42 or more). A total sum of each sub-scale is not intended to be measured. Higher scores on the compassion satisfaction scale indicate a better outcome. Lower scores on burnout and secondary trauma indicate a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
|
| Secondary | Teachers' Sense of Self-Efficacy (Short Form) (TSSE) | The Teachers' Sense of Self-Efficacy is a 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 1 (nothing) to 9 (a great deal). Higher scores indicate higher self-perceptions of self-efficacy. Higher scores indicate a better outcome. A minimum score isa 12, and a maximum score of 108 is possible on the scale. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
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| Secondary | PROMIS Sleep Disturbance Scales (PROMIS) | The PROMIS Sleep Disturbance Scale is 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. The scale's minimum score is an 8, and the scale's maximum score is 40; therefore, lower scores indicate better quality of sleep. Lower scores indicate a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
|
|
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| Secondary | PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a 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. The scale's minimum score is a zero with a maximum score being an 80. Therefore, lower scores indicate an improvement in traumatic stress symptomology. Lower scores indicate a better outcome. | 20 rural teachers in a southwestern Montana school district | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention (Baseline), Post-Intervention (Week 6) |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Post-Intervention Compassion Satisfaction |
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| Pre-Intervention Secondary Traumatic Stress |
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| Post-Intervention Secondary Traumatic Stress |
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