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

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ClinicalTrials.gov Identifier: NCT05085392
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Lauren Davis, Montana State University

Brief 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 high school-aged students and teachers. The immediate goals of this study are: 1) measure the physical and mental health outcomes in adolescents resulting from a trauma-informed yoga intervention designed to foster positive youth development; and 2) promote student health by supporting teacher wellbeing through a concurrent, remotely-delivered trauma-informed yoga intervention.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Stress Behavioral: Trauma-Informed Yoga Not Applicable

Detailed Description:

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 high school-aged students and teachers. The immediate goals of this study are: 1) measure the physical and mental health outcomes in adolescents resulting from a trauma-informed yoga intervention designed to foster positive youth development; and 2) promote student health by supporting teacher wellbeing through a concurrent, remotely-delivered trauma-informed yoga intervention.

Specific Aims: Aim 1: Expansion of pilot study to teachers in the Livingston school district. Aim 2: Expand to study to Livingston high school students/teachers and rural schools remotely in Park County students/teachers. Aim 3: Conduct outcome and process evaluation to determine most effective intervention design. Methods: This study will enroll a minimum 30 Livingston teachers (taught trauma-informed yoga via Zoom) in year one and will aim to add 30 Livingston high school and rural Park county high school students and teachers to the intervention in year two (delivered via Zoom). Twice weekly 45-minute trauma-informed yoga sessions during the 6-week intervention period will occur remotely (for teachers and Park county high school students) and face-to-face for Livingston students. To measure physical health outcomes, pre, mid-, and post-intervention cortisol testing will be utilized to evaluate any changes in student and teacher stress levels before and after the program. Heart rate variability will also be assessed for students and 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 students and 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. To assess teacher wellness, the same physical health data and similar mental health assessments as students (focusing on depression and anxiety) will be collected, and 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. 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 (both in Livingston and in rural Park county) and to students (in rural Park county).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
Estimated Study Start Date : January 15, 2022
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group Yoga
35 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Behavioral: Trauma-Informed Yoga
6 weeks of twice weekly trauma-informed yoga for 45 minutes per session

No Intervention: Control Group
35 rural teachers in a southwestern Montana school district



Primary Outcome Measures :
  1. Change in Salivary Cortisol Levels [ Time Frame: Baseline, Midpoint (3 weeks), 6 weeks ]
    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. Patient Health Questionnaire [ Time Frame: Baseline and 6 weeks ]
    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. Generalized Anxiety Disorder-7 Anxiety Scale [ Time Frame: Baseline and 6 weeks ]
    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. Heart Rate Variability [ Time Frame: Baseline, Midpoint (3 weeks), 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Baseline and 6 weeks ]
    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) [ Time Frame: Baseline and 6 weeks ]
    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) [ Time Frame: Baseline and 6 weeks ]
    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 [ Time Frame: Baseline and 6 weeks ]
    Teachers 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) [ Time Frame: Baseline and 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any teacher currently employed by the Livingston school district who wishes to participate in the intervention (up to 35 participants)

Exclusion Criteria:

  • Only teachers will be considered for this study (i.e., no school staff, administrators, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085392


Contacts
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Contact: Lauren Davis, Ed. D 8287736328 lauren.davis6@montana.edu
Contact: Alexandra Aylward, Ph. D 4065893248 alexandra.aylward@montana.edu

Locations
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United States, Montana
Park High School
Livingston, Montana, United States, 59047
Sponsors and Collaborators
Montana State University
Investigators
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Study Director: Alexandra Adams, MD, Ph.D Montana State University
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Responsible Party: Lauren Davis, Assistant Professor of Curriculum & Instruction, Montana State University
ClinicalTrials.gov Identifier: NCT05085392    
Other Study ID Numbers: MontanaSUYear3
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms