A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2

NCT05844007 | Completed Results

• 2 other identifiers: MontanaSUYear45P20GM104417
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Trauma and Stressor Related Disorders

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Connor-Davidson Resilience Scale (CD-RISC)

  Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

• Professional Quality of Life Index (Pro-QOL)

  Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

• Teachers' Sense of Self-Efficacy (Short Form)

  Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

• PROMIS Sleep Disturbance Scales

  Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

• PTSD Checklist for DSM-5 (PCL-5)

  Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6

Study Arms (3)

High School Students: Remote Delivery

EXPERIMENTAL

Remote delivery of trauma-informed yoga session for high school students

Behavioral: Trauma-Informed Yoga

High School Students: Face-to-Face Delivery

EXPERIMENTAL

Face-to-face delivery of trauma-informed yoga session for high school students

Behavioral: Trauma-Informed Yoga

Teachers: Remote Delivery

EXPERIMENTAL

Remote delivery of trauma-informed yoga session for teachers

Behavioral: Trauma-Informed Yoga

Interventions

Trauma-Informed Yoga BEHAVIORAL

Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions

High School Students: Face-to-Face Delivery; High School Students: Remote Delivery; Teachers: Remote Delivery

Eligibility Criteria

• Age: 13 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana

Sponsors & Collaborators

• Montana State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Park High School

Livingston, Montana, 59047, United States

Location

MeSH Terms

Conditions

Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Lauren Davis
• Organization: Montana State University

lauren.davis6@montana.edu

828-773-6328

Study Officials

• Alexandra Adams, MD, Ph.D

  Montana State University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: January 13, 2023
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)