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NCT Number: NCT04234425

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

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.

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Key information

Conditions

Depression, Anxiety Adolescent Behavior Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Park High School

Livingston, Montana, 59047, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-Informed Yoga

Behavioral

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

Primary outcomes

  1. Salivary Cortisol Testing

    Time frame: Baseline and 4 weeks (Midpoint)

    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 outcomes

  1. Generalized Anxiety Disorder-7 Anxiety Scale

    Time frame: Baseline and 7 weeks after beginning of intervention

    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.

  2. Patient Health Questionnaire for Adolescents

    Time frame: Baseline and 7 weeks after beginning of intervention

    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.

  3. Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)

    Time frame: Baseline and 7 weeks after beginning of intervention

    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.

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Registry information

Official study title

A Trauma-Informed Approach for Positive Youth Development for Montana

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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