Trial Outcomes & Findings for A Trauma-Informed Approach for Positive Youth Development for Montana Students (NCT NCT04664855)
NCT ID: NCT04664855
Last Updated: 2021-11-15
Results Overview
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.
COMPLETED
NA
47 participants
Week 1 and. Week 6
2021-11-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Yoga Group
n=23 Participants
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
|
Control Group (No Yoga Intervention)
n=22 Participants
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=23 Participants
|
22 Participants
n=22 Participants
|
45 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 0.5 • n=23 Participants
|
16.5 years
STANDARD_DEVIATION 1.12 • n=22 Participants
|
15.4 years
STANDARD_DEVIATION 1.36 • n=45 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
19 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=23 Participants
|
19 Participants
n=22 Participants
|
26 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
22 Participants
n=22 Participants
|
45 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Week 1 and. Week 6Population: High school students enrolled in a physical education classroom in rural Montana
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.
Outcome measures
| Measure |
Experimental Yoga Group
n=23 Participants
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
|
Control Group (No Yoga Intervention)
n=22 Participants
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
|
|---|---|---|
|
Change in Salivary Cortisol Levels
|
-0.26 ug/dl
Standard Deviation .12
|
-0.17 ug/dl
Standard Deviation .27
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: High school students enrolled in a physical education class in rural Montana
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.
Outcome measures
| Measure |
Experimental Yoga Group
n=23 Participants
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
|
Control Group (No Yoga Intervention)
n=22 Participants
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
|
|---|---|---|
|
Patient Health Questionnaire for Adolescents
Baseline Mean
|
8.00 score on a scale
Standard Deviation 6.75
|
5.36 score on a scale
Standard Deviation 4.89
|
|
Patient Health Questionnaire for Adolescents
Post-Intervention Mean
|
6.39 score on a scale
Standard Deviation 6.73
|
4.18 score on a scale
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: High school students enrolled in a physical education class in rural Montana
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.
Outcome measures
| Measure |
Experimental Yoga Group
n=23 Participants
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
|
Control Group (No Yoga Intervention)
n=22 Participants
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
|
|---|---|---|
|
Generalized Anxiety Disorder-7 Anxiety Scale
Pre-Intervention Mean
|
6.83 score on a scale
Standard Deviation 5.25
|
5.27 score on a scale
Standard Deviation 5.13
|
|
Generalized Anxiety Disorder-7 Anxiety Scale
Post-Intervention Mean
|
5.35 score on a scale
Standard Deviation 5.97
|
4.55 score on a scale
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: High school students enrolled in a physical education class in rural Montana
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.
Outcome measures
| Measure |
Experimental Yoga Group
n=23 Participants
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
|
Control Group (No Yoga Intervention)
n=22 Participants
22 freshman-senior high school students enrolled in a health and wellness/physical education class at a rural Montana high school
|
|---|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
Pre-intervention mean
|
25.39 score on a scale
Standard Deviation 7.45
|
28.32 score on a scale
Standard Deviation 7.11
|
|
Connor-Davidson Resilience Scale (CD-RISC)
Post-Intervention Mean
|
24.87 score on a scale
Standard Deviation 9.71
|
30.45 score on a scale
Standard Deviation 6.44
|
Adverse Events
Experimental Yoga Group
Control Group (No Yoga Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place