- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05844007
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
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Livingston, Montana, United States, 59047
- Park High School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High School Students: Remote Delivery
Remote delivery of trauma-informed yoga session for high school students
|
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
Face-to-face delivery of trauma-informed yoga session for high school students
|
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Experimental: Teachers: Remote Delivery
Remote delivery of trauma-informed yoga session for teachers
|
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary Cortisol Levels
Time Frame: Pre-Intervention, first day of Week 1 and post-intervention, last day of 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 (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
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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.
|
Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
|
Generalized Anxiety Disorder-7 Anxiety Scale
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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.
|
Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
|
Heart Rate Variability
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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.
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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. 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
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Professional Quality of Life Index (Pro-QOL)
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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).
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.
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Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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Teachers' Sense of Self-Efficacy (Short Form)
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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 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
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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).
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.
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Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of 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).
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.
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Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Alexandra Adams, MD, Ph.D, Montana State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MontanaSUYear4
- 5P20GM104417 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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