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

Stress Clinical Trial

Official title:

A Trauma-Informed Approach for Positive Youth Development for Montana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234425
• Other study ID #: Davis01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Depression, Anxiety
• Stress

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