NCT04234425

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

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

Study Start

First participant enrolled

November 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

January 14, 2020

Results QC Date

September 22, 2020

Last Update Submit

December 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Generalized Anxiety Disorder-7 Anxiety Scale

    Baseline and 7 weeks after beginning of intervention

  • Patient Health Questionnaire for Adolescents

    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

Study Arms (1)

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.

Behavioral: Trauma-Informed Yoga

Interventions

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

Experimental Group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students enrolled in a specific weight training class at predetermined high school in rural Montana

You may not qualify if:

  • Students not enrolled in a specific weight training class at predetermined high school in rural Montana

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park High School

Livingston, Montana, 59047, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Dr. Lauren Davis
Organization
Montana State University

Study Officials

  • Lauren E Davis, Doctoral

    Montana State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
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

January 14, 2020

First Posted

January 21, 2020

Study Start

November 15, 2019

Primary Completion

March 12, 2020

Study Completion

September 22, 2020

Last Updated

January 5, 2021

Results First Posted

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations