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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04234425
Other study ID # Davis01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date September 22, 2020

Study information

Verified date December 2020
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 determine viability of a partnership with a rural southwestern Montana school and test the feasibility of a piloted implementation of a trauma-informed yoga intervention to address behavioral health outcomes and positive youth development.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 22, 2020
Est. primary completion date March 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: - Students enrolled in a specific weight training class at predetermined high school in rural Montana Exclusion Criteria: - Students not enrolled in a specific weight training class at predetermined high school in rural Montana

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Trauma-Informed Yoga
Trauma-Informed Yoga practice held within a high school weight training class

Locations

Country Name City State
United States Park High School Livingston Montana

Sponsors (1)

Lead Sponsor Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Salivary Cortisol Testing 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 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. Baseline and 4 weeks (Midpoint)
Secondary 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. Baseline and 7 weeks after beginning of intervention
Secondary 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 reduction in score from pre- to post-assessment indicates an improvement in symptomology. Baseline and 7 weeks after beginning of intervention
Secondary Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score) This 25 item questionnaire is a brief emotional and behavioral scale for adolescents based on psychological attributes. Items are scored on a Likert scale from 0 (Not True) to 2 (Certainly True). The range in overall scores is 0-40. A reduction in score from pre- to post-assessment indicates an improvement in symptomology/outcomes. Baseline and 7 weeks after beginning of intervention
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