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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

Week 1 and. Week 6

Results posted on

2021-11-15

Participant Flow

Participant milestones

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

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

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 6

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group (No Yoga Intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lauren Davis

Montana State University

Phone: 8287736328

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place