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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 Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04664855
Enrollment
47
Registered
2020-12-11
Start date
2021-01-15
Completion date
2021-03-05
Last updated
2021-11-15

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

Conditions

Depression, Anxiety, Stress, Suicidal Ideation, Trauma

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.

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.

Interventions

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

Sponsors

Montana State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Change in Salivary Cortisol LevelsWeek 1 and. Week 6Students 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

MeasureTime frameDescription
Patient Health Questionnaire for AdolescentsBaseline and 6 weeksThis 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.
Generalized Anxiety Disorder-7 Anxiety ScaleBaseline and 6 weeksThis 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.
Connor-Davidson Resilience Scale (CD-RISC)Baseline and 6 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Experimental Yoga Group
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
23
Control Group (No Yoga Intervention)
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
22
Total45

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicControl Group (No Yoga Intervention)TotalExperimental Yoga Group
Age, Categorical
<=18 years
22 Participants45 Participants23 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous16.5 years
STANDARD_DEVIATION 1.12
15.4 years
STANDARD_DEVIATION 1.36
14.4 years
STANDARD_DEVIATION 0.5
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
22 Participants45 Participants23 Participants
Sex: Female, Male
Female
3 Participants19 Participants16 Participants
Sex: Female, Male
Male
19 Participants26 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 22
other
Total, other adverse events
0 / 230 / 22
serious
Total, serious adverse events
0 / 230 / 22

Outcome results

Primary

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.

Time frame: Week 1 and. Week 6

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

ArmMeasureValue (MEAN)Dispersion
Experimental Yoga GroupChange in Salivary Cortisol Levels-0.26 ug/dlStandard Deviation 0.12
Control Group (No Yoga Intervention)Change in Salivary Cortisol Levels-0.17 ug/dlStandard Deviation 0.27
Secondary

Connor-Davidson Resilience Scale (CD-RISC)

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Yoga GroupConnor-Davidson Resilience Scale (CD-RISC)Pre-intervention mean25.39 score on a scaleStandard Deviation 7.45
Experimental Yoga GroupConnor-Davidson Resilience Scale (CD-RISC)Post-Intervention Mean24.87 score on a scaleStandard Deviation 9.71
Control Group (No Yoga Intervention)Connor-Davidson Resilience Scale (CD-RISC)Pre-intervention mean28.32 score on a scaleStandard Deviation 7.11
Control Group (No Yoga Intervention)Connor-Davidson Resilience Scale (CD-RISC)Post-Intervention Mean30.45 score on a scaleStandard Deviation 6.44
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 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

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

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Yoga GroupGeneralized Anxiety Disorder-7 Anxiety ScalePre-Intervention Mean6.83 score on a scaleStandard Deviation 5.25
Experimental Yoga GroupGeneralized Anxiety Disorder-7 Anxiety ScalePost-Intervention Mean5.35 score on a scaleStandard Deviation 5.97
Control Group (No Yoga Intervention)Generalized Anxiety Disorder-7 Anxiety ScalePre-Intervention Mean5.27 score on a scaleStandard Deviation 5.13
Control Group (No Yoga Intervention)Generalized Anxiety Disorder-7 Anxiety ScalePost-Intervention Mean4.55 score on a scaleStandard Deviation 4.54
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 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

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

ArmMeasureGroupValue (MEAN)Dispersion
Experimental Yoga GroupPatient Health Questionnaire for AdolescentsBaseline Mean8.00 score on a scaleStandard Deviation 6.75
Experimental Yoga GroupPatient Health Questionnaire for AdolescentsPost-Intervention Mean6.39 score on a scaleStandard Deviation 6.73
Control Group (No Yoga Intervention)Patient Health Questionnaire for AdolescentsBaseline Mean5.36 score on a scaleStandard Deviation 4.89
Control Group (No Yoga Intervention)Patient Health Questionnaire for AdolescentsPost-Intervention Mean4.18 score on a scaleStandard Deviation 5.24

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026