Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04664855 |
| Other study ID # |
MontanaSUYear2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
March 5, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Montana State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
