Back to resultsA Trauma-Informed Approach for Positive Youth Development for Montana Students
Primary Purpose
Depression, Anxiety, Adolescent Behavior, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Informed Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Depression, Anxiety
Eligibility Criteria
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
Sites / Locations
- Park High School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm Description
18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04234425
First Posted
January 14, 2020
Last Updated
December 31, 2020
Sponsor
Montana State University
1. Study Identification
Unique Protocol Identification Number
NCT04234425
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
September 22, 2020 (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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Adolescent Behavior, Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
18 high school students in a weight training class will be assigned to this experimental group and will receive the one-hour intervention twice weekly for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Informed Yoga
Intervention Description
Trauma-Informed Yoga practice held within a high school weight training class
Primary Outcome Measure Information:
Title
Salivary Cortisol Testing
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 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.
Time Frame
Baseline and 4 weeks (Midpoint)
Secondary Outcome Measure Information:
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 reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Time Frame
Baseline and 7 weeks after beginning of intervention
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 reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Time Frame
Baseline and 7 weeks after beginning of intervention
Title
Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)
Description
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.
Time Frame
Baseline and 7 weeks after beginning of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren E Davis, Doctoral
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park High School
City
Livingston
State/Province
Montana
ZIP/Postal Code
59047
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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