NCT04664855

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 measure physical and mental health outcomes in adolescents resulting from a trauma-informed yoga intervention designed to foster positive youth development and student success. It builds on feasibility study for year one in which 19 experimental condition participants engaged in an 8-week yoga program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 15, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

December 1, 2020

Results QC Date

September 16, 2021

Last Update Submit

November 11, 2021

Conditions

Depression, AnxietySuicidal IdeationStressTrauma

Outcome Measures

Primary Outcomes (1)

  • Change in Salivary Cortisol Levels

    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 changed cortisol levels. A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study; the mean change pre vs. post is provided here. Negative change indicates improvement in stress levels.

    Week 1 and. Week 6

Secondary Outcomes (3)

  • Patient Health Questionnaire for Adolescents

    Baseline and 6 weeks

  • Generalized Anxiety Disorder-7 Anxiety Scale

    Baseline and 6 weeks

  • Connor-Davidson Resilience Scale (CD-RISC)

    Baseline and 6 weeks

Study Arms (2)

Experimental Yoga Group

EXPERIMENTAL

35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school

Other: Trauma-Informed Yoga

Control Group (No Yoga Intervention)

NO INTERVENTION

20 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school

Interventions

Trauma-Informed YogaOTHER

8 weeks of twice weekly trauma-informed yoga for 45 minutes per session

Experimental Yoga Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Freshmen enrolled in a health and wellness/physical education class at a rural Montana High School

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59718, United States

Location

Related Publications (1)

  • Davis L, Aylward A. Mitigating Rural Adolescent Trauma: Remote Delivery of a Trauma-Informed Yoga Intervention During COVID-19. J Child Adolesc Trauma. 2022 Dec 1;16(3):1-14. doi: 10.1007/s40653-022-00496-9. Online ahead of print.

    PMID: 36471891DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersSuicidal IdeationWounds and Injuries

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSuicideSelf-Injurious Behavior

Results Point of Contact

Title
Dr. Lauren Davis
Organization
Montana State University
lauren.davis6@montana.edu
8287736328

Study Officials

  • Lauren Davis, Ed. D

    Montana State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 11, 2020

Study Start

January 15, 2021

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

November 15, 2021

Results First Posted

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)