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

• Sponsor: Montana State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04664855
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 29.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Anxiety; Suicidal Ideation; Stress; Trauma	Other: Trauma-Informed Yoga	N/A

Detailed Description

mental and physical health issues (17). Stressors deriving from low socioeconomic status and/or traumatic childhood experiences such as abuse or neglect are exacerbated by today's educational culture, where mandated practices such as standardized testing and post-graduation plans are cited as primary causes for stress in adolescents' lives (4).

In Montana, the childhood abuse/neglect rate was 8.3 per 1000 children in 2015, which indicates a 56.8% increase from 2014 (16); nationally, in the same year the abuse/neglect rate was 9 per 1000 children (15). Childhood trauma tends to cluster in areas of high poverty; in Livingston Public Schools in rural southwestern Montana, for instance, 52% of students were eligible for free and reduced-price lunch in 2016, which is the same as the national rate (4; 40). In Livingston, 13.2% of residents are listed as living in poverty, which is slightly above the 12.3% national rate (53). These unfortunate but common childhood stressors can result in significant public health issues including poor mental health, suicidality, substance abuse, juvenile offenses, and autoimmune disease (8). Despite Livingston being on par with national childhood poverty and abuse trends, the suicide rates in Livingston are triple the national average (42). Substance abuse among minors in Montana, which is often comorbid with mental health issues and suicidality, is prevalent; according to a 2015 report by the office of adolescent health, 38% of Montana high schoolers reported having used marijuana at least once, 20% self-reported using alcohol before age 13, and 30% reported using e-cigarettes (36).

Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to cultivate positive coping skills to buffer the negative effects of stressors among school-aged children. Because of the geographic isolation and resulting lack of resources for many schools in Montana, there is a need for innovative and novel school- and community-centered interventions in order to address the varied health needs of rural adolescents. According to research, yoga and mindfulness can have a positive impact on youth development (6; 7; 13; 14). The second year of this pilot study prepares the way for a robust intervention by examining efficacy of this intervention modality compared to a control group in a collaborative school setting, basing the framework of the study on the tenets of community-based participatory research (16). Existing validated measures of efficacy using physical and mental health measures will be used to generate student, teacher, and parent reports of perceived strengths and difficulties, along with measures of anxiety and depressive symptomology. Secondary outcomes of school performance also will be assessed. Efficacy of the intervention will be ascertained through observational and qualitative data obtained utilizing participant, school, and community partner interviews; quantitative feedback will also be gathered from community and school stakeholders to evaluate program outcomes. From this data analysis, decisions regarding any necessary modifications to experimental design and program implementation will be made for third year of the study, which will lead to an expansion to middle level students within the same school district.

Aim 1: Pilot test a trauma-informed yoga intervention for 15-18 year-old male and female high school students.

H1: Students who participate in the pilot intervention will demonstrate improved mental health as measured by a decrease in depressive and anxiety symptomology at the conclusion of the study (week 8) as compared to participants in the control group.

H2: Students who participate in the pilot intervention will demonstrate improved physical health as measured by a decreased resting heart rate, improved sleep patterns, and reduced cortisol levels at the conclusion of the study (week 8) as compared to participants in the control group.

Aim 2: Evaluate the study's school-community-academic partnership at the conclusion of the program using a mixed methods survey. The CAB will meet monthly to determine program adjustments. Survey administration and data analysis will occur in summer 2021. The PI will share results with the CAB to determine areas for program refinement and assess need for study continuation or expansion into multiple schools for year 3.

H3: Findings from the partnership evaluation will be used to refine the community engagement component of the study in Year 3.

This data will be used to determine intervention and program efficacy in order to indicate areas for revision and refinement in year 3 of this study; the data will also inform future implementation plans for program expansion to the middle school level within the same school district.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Trauma-Informed Approach for Positive Youth Development for Montana Students
• Actual Study Start Date: Jan 15, 2021
• Actual Primary Completion Date: Mar 5, 2021
• Actual Study Completion Date: Mar 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Yoga Group 35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school	Other: Trauma-Informed Yoga; 8 weeks of twice weekly trauma-informed yoga for 45 minutes per session
No Intervention: Control Group (No Yoga Intervention) 20 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school

Outcome Measures

Primary Outcome Measures

1. Change in Salivary Cortisol Levels [Week 1 and. Week 6]

   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.

Secondary Outcome Measures

1. Patient Health Questionnaire for Adolescents [Baseline and 6 weeks]

   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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.

2. Generalized Anxiety Disorder-7 Anxiety Scale [Baseline and 6 weeks]

   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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.

3. Connor-Davidson Resilience Scale (CD-RISC) [Baseline and 6 weeks]

   The CD-RISC 10 is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. Possible scores range from 0-100. A higher score indicates higher resilience. Pre and post-intervention means are reported here.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montana State University	Bozeman	Montana	United States	59718

Sponsors and Collaborators

• Montana State University

Investigators

• Principal Investigator: Lauren Davis, Ed. D, Montana State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2021
• Informed Consent Form - May 21, 2020

More Information

Publications

None provided.

• Responsible Party: Lauren Davis, Assistant Professor, Montana State University
• ClinicalTrials.gov Identifier: NCT04664855
• Other Study ID Numbers: MontanaSUYear2
• First Posted: Dec 11, 2020
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries; Suicidal Ideation

Study Results

Participant Flow

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
Period Title: Overall Study
STARTED	23	24
COMPLETED	23	22
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)	Total
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	23 100%	22 100%	45 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.4 (0.5)	16.5 (1.12)	15.4 (1.36)
Sex: Female, Male (Count of Participants)
Female	16 69.6%	3 13.6%	19 42.2%
Male	7 30.4%	19 86.4%	26 57.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	23 100%	22 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Change in Salivary Cortisol Levels
Description	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.
Time Frame	Week 1 and. Week 6

Outcome Measure Data

Analysis Population Description

High school students enrolled in a physical education classroom in rural Montana

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
Measure Participants	23	22
Mean (Standard Deviation) [ug/dl]	-0.26 (.12)	-0.17 (.27)

2. Secondary Outcome

Title	Patient Health Questionnaire for Adolescents
Description	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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

High school students enrolled in a physical education class in rural Montana

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
Measure Participants	23	22
Baseline Mean	8.00 (6.75)	5.36 (4.89)
Post-Intervention Mean	6.39 (6.73)	4.18 (5.24)

3. Secondary Outcome

Title	Generalized Anxiety Disorder-7 Anxiety Scale
Description	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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

High school students enrolled in a physical education class in rural Montana

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
Measure Participants	23	22
Pre-Intervention Mean	6.83 (5.25)	5.27 (5.13)
Post-Intervention Mean	5.35 (5.97)	4.55 (4.54)

4. Secondary Outcome

Title	Connor-Davidson Resilience Scale (CD-RISC)
Description	The CD-RISC 10 is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. Possible scores range from 0-100. A higher score indicates higher resilience. Pre and post-intervention means are reported here.
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

High school students enrolled in a physical education class in rural Montana

Arm/Group Title	Experimental Yoga Group	Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session	22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
Measure Participants	23	22
Pre-intervention mean	25.39 (7.45)	28.32 (7.11)
Post-Intervention Mean	24.87 (9.71)	30.45 (6.44)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Experimental Yoga Group		Control Group (No Yoga Intervention)
Arm/Group Description	23 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session		22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
All Cause Mortality
	Experimental Yoga Group		Control Group (No Yoga Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Serious Adverse Events
	Experimental Yoga Group		Control Group (No Yoga Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Yoga Group		Control Group (No Yoga Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.