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

A Trauma-Informed Approach for Positive Youth Development for Montana

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04234425
Enrollment
18
Registered
2020-01-21
Start date
2019-11-15
Completion date
2020-09-22
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Depression, Anxiety, Stress

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.

Interventions

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

Sponsors

Montana State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Salivary Cortisol TestingBaseline 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

MeasureTime frameDescription
Generalized Anxiety Disorder-7 Anxiety ScaleBaseline and 7 weeks after beginning of interventionThis 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 AdolescentsBaseline and 7 weeks after beginning of interventionThis 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)Baseline and 7 weeks after beginning of interventionThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Experimental Group
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. Trauma-Informed Yoga: Trauma-Informed Yoga practice held within a high school weight training class
18
Total18

Baseline characteristics

CharacteristicExperimental Group
Age, Categorical
<=18 years
18 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous17 years
STANDARD_DEVIATION 0.83
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
16 Participants
Region of Enrollment
United States
18 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
16 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 18
other
Total, other adverse events
0 / 18
serious
Total, serious adverse events
0 / 18

Outcome results

Primary

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.

Time frame: Baseline and 4 weeks (Midpoint)

Population: 18 students in a weight training class in a rural Montana high school

ArmMeasureValue (MEAN)Dispersion
Experimental Group-Midpoint Data (4 Weeks)Salivary Cortisol Testing0.245 ug/dlStandard Deviation 0.1356
Experimental Group-Baseline DataSalivary Cortisol Testing0.3088 ug/dlStandard Deviation 0.1552
Secondary

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.

Time frame: Baseline and 7 weeks after beginning of intervention

Population: High School Students in rural Montana

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Group-Midpoint Data (4 Weeks)Generalized Anxiety Disorder-7 Anxiety ScalePost Survey Results4.20 score on a scaleStandard Deviation 5.36
Experimental Group-Midpoint Data (4 Weeks)Generalized Anxiety Disorder-7 Anxiety ScalePre-Survey Results7.33 score on a scaleStandard Deviation 5.44
p-value: 0.017t-test, 2 sided
Secondary

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.

Time frame: Baseline and 7 weeks after beginning of intervention

Population: high school students in rural Montana

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Group-Midpoint Data (4 Weeks)Patient Health Questionnaire for AdolescentsPost-Survey Results4.20 score on a scaleStandard Deviation 7.06
Experimental Group-Midpoint Data (4 Weeks)Patient Health Questionnaire for AdolescentsPre-Survey Results6.72 score on a scaleStandard Deviation 4.42
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary

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.

Time frame: Baseline and 7 weeks after beginning of intervention

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Group-Midpoint Data (4 Weeks)Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)Post-Survey Overall Score20.47 score on a scaleStandard Deviation 7.33
Experimental Group-Midpoint Data (4 Weeks)Strengths and Difficulties Questionnaire for Ages 11-17 (Overall Score)Pre-Survey Overall Score23.72 score on a scaleStandard Deviation 7.48
p-value: 0.026t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026