- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664855
A Trauma-Informed Approach for Positive Youth Development for Montana Students
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59718
- Montana State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Freshmen enrolled in a health and wellness/physical education class at a rural Montana High School
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Yoga Group
35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school
|
8 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|
No Intervention: Control Group (No Yoga Intervention)
20 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Salivary Cortisol Levels
Time Frame: Week 1 and. Week 6
|
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.
|
Week 1 and. Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire for Adolescents
Time Frame: Baseline and 6 weeks
|
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.
|
Baseline and 6 weeks
|
|
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 negative change in score from pre- to post-assessment indicates an improvement in symptomology.
Pre and post-intervention means are reported here.
|
Baseline and 6 weeks
|
|
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. Possible scores range from 0-100.
A higher score indicates higher resilience.
Pre and post-intervention means are reported here.
|
Baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauren Davis, Ed. 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
- MontanaSUYear2
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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