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Clinical Trials/NCT04234425
NCT04234425CompletedNot Applicable

A Trauma-Informed Approach for Positive Youth Development for Montana

Montana State University1 site in 1 country18 target enrollmentStarted: November 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Salivary Cortisol Testing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
11 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Experimental Group

Experimental

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: Trauma-Informed Yoga (Behavioral)

Outcomes

Primary Outcomes

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

  • Patient Health Questionnaire for Adolescents(Baseline and 7 weeks after beginning of intervention)
  • Generalized Anxiety Disorder-7 Anxiety Scale(Baseline and 7 weeks after beginning of intervention)
  • Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)(Baseline and 7 weeks after beginning of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lauren Davis

Assistant Professor

Montana State University

Study Sites (1)

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