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A Trauma-Informed Approach for Positive Youth Development for Montana Students

Primary Purpose

Depression, Anxiety, Suicidal Ideation, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Informed Yoga
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Anxiety

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Freshmen enrolled in a health and wellness/physical education class at a rural Montana High School

Exclusion Criteria:

None

Sites / Locations

  • Montana State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Yoga Group

Control Group (No Yoga Intervention)

Arm Description

35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school

20 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school

Outcomes

Primary Outcome Measures

Change in Salivary Cortisol Levels
Students 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 changed cortisol levels. A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study; the mean change pre vs. post is provided here. Negative change indicates improvement in stress levels.

Secondary Outcome Measures

Patient Health Questionnaire for Adolescents
This 9 item questionnaire is designed to evaluate severity of depressive symptoms in adolescents. 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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
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. Possible scores range from 0-100. A higher score indicates higher resilience. Pre and post-intervention means are reported here.

Full Information

First Posted
December 1, 2020
Last Updated
November 11, 2021
Sponsor
Montana State University
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1. Study Identification

Unique Protocol Identification Number
NCT04664855
Brief Title
A Trauma-Informed Approach for Positive Youth Development for Montana Students
Official Title
A Trauma-Informed Approach for Positive Youth Development for Montana Students
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to measure physical and mental health outcomes in adolescents resulting from a trauma-informed yoga intervention designed to foster positive youth development and student success. It builds on feasibility study for year one in which 19 experimental condition participants engaged in an 8-week yoga program.
Detailed Description
mental and physical health issues (17). Stressors deriving from low socioeconomic status and/or traumatic childhood experiences such as abuse or neglect are exacerbated by today's educational culture, where mandated practices such as standardized testing and post-graduation plans are cited as primary causes for stress in adolescents' lives (4). In Montana, the childhood abuse/neglect rate was 8.3 per 1000 children in 2015, which indicates a 56.8% increase from 2014 (16); nationally, in the same year the abuse/neglect rate was 9 per 1000 children (15). Childhood trauma tends to cluster in areas of high poverty; in Livingston Public Schools in rural southwestern Montana, for instance, 52% of students were eligible for free and reduced-price lunch in 2016, which is the same as the national rate (4; 40). In Livingston, 13.2% of residents are listed as living in poverty, which is slightly above the 12.3% national rate (53). These unfortunate but common childhood stressors can result in significant public health issues including poor mental health, suicidality, substance abuse, juvenile offenses, and autoimmune disease (8). Despite Livingston being on par with national childhood poverty and abuse trends, the suicide rates in Livingston are triple the national average (42). Substance abuse among minors in Montana, which is often comorbid with mental health issues and suicidality, is prevalent; according to a 2015 report by the office of adolescent health, 38% of Montana high schoolers reported having used marijuana at least once, 20% self-reported using alcohol before age 13, and 30% reported using e-cigarettes (36). Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to cultivate positive coping skills to buffer the negative effects of stressors among school-aged children. Because of the geographic isolation and resulting lack of resources for many schools in Montana, there is a need for innovative and novel school- and community-centered interventions in order to address the varied health needs of rural adolescents. According to research, yoga and mindfulness can have a positive impact on youth development (6; 7; 13; 14). The second year of this pilot study prepares the way for a robust intervention by examining efficacy of this intervention modality compared to a control group in a collaborative school setting, basing the framework of the study on the tenets of community-based participatory research (16). Existing validated measures of efficacy using physical and mental health measures will be used to generate student, teacher, and parent reports of perceived strengths and difficulties, along with measures of anxiety and depressive symptomology. Secondary outcomes of school performance also will be assessed. Efficacy of the intervention will be ascertained through observational and qualitative data obtained utilizing participant, school, and community partner interviews; quantitative feedback will also be gathered from community and school stakeholders to evaluate program outcomes. From this data analysis, decisions regarding any necessary modifications to experimental design and program implementation will be made for third year of the study, which will lead to an expansion to middle level students within the same school district. Aim 1: Pilot test a trauma-informed yoga intervention for 15-18 year-old male and female high school students. H1: Students who participate in the pilot intervention will demonstrate improved mental health as measured by a decrease in depressive and anxiety symptomology at the conclusion of the study (week 8) as compared to participants in the control group. H2: Students who participate in the pilot intervention will demonstrate improved physical health as measured by a decreased resting heart rate, improved sleep patterns, and reduced cortisol levels at the conclusion of the study (week 8) as compared to participants in the control group. Aim 2: Evaluate the study's school-community-academic partnership at the conclusion of the program using a mixed methods survey. The CAB will meet monthly to determine program adjustments. Survey administration and data analysis will occur in summer 2021. The PI will share results with the CAB to determine areas for program refinement and assess need for study continuation or expansion into multiple schools for year 3. H3: Findings from the partnership evaluation will be used to refine the community engagement component of the study in Year 3. This data will be used to determine intervention and program efficacy in order to indicate areas for revision and refinement in year 3 of this study; the data will also inform future implementation plans for program expansion to the middle school level within the same school district.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Suicidal Ideation, Stress, Trauma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Yoga Group
Arm Type
Experimental
Arm Description
35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school
Arm Title
Control Group (No Yoga Intervention)
Arm Type
No Intervention
Arm Description
20 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school
Intervention Type
Other
Intervention Name(s)
Trauma-Informed Yoga
Intervention Description
8 weeks of twice weekly trauma-informed yoga for 45 minutes per session
Primary Outcome Measure Information:
Title
Change in Salivary Cortisol Levels
Description
Students 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 changed cortisol levels. A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study; the mean change pre vs. post is provided here. Negative change indicates improvement in stress levels.
Time Frame
Week 1 and. Week 6
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire for Adolescents
Description
This 9 item questionnaire is designed to evaluate severity of depressive symptoms in adolescents. 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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
Time Frame
Baseline and 6 weeks
Title
Generalized Anxiety Disorder-7 Anxiety Scale
Description
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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
Time Frame
Baseline and 6 weeks
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
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. Possible scores range from 0-100. A higher score indicates higher resilience. Pre and post-intervention means are reported here.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Freshmen enrolled in a health and wellness/physical education class at a rural Montana High School Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Davis, Ed. D
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Trauma-Informed Approach for Positive Youth Development for Montana Students

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