Trial Outcomes & Findings for A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2 (NCT NCT05844007)
NCT ID: NCT05844007
Last Updated: 2024-03-26
Results Overview
Participants 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 (week 1) and on the last day of the intervention (week 6) 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
COMPLETED
NA
83 participants
Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6
2024-03-26
Participant Flow
Participant milestones
| Measure |
High School Students: Remote Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
43
|
|
Overall Study
COMPLETED
|
22
|
18
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
0 Participants
n=43 Participants
|
40 Participants
n=83 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
42 Participants
n=43 Participants
|
42 Participants
n=83 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=83 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=22 Participants
|
9 Participants
n=18 Participants
|
37 Participants
n=43 Participants
|
57 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=22 Participants
|
9 Participants
n=18 Participants
|
6 Participants
n=43 Participants
|
26 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Cortisol Levels
|
0.3 micrograms per deciliter
STANDARD_DEVIATION .40 • n=22 Participants
|
.43 micrograms per deciliter
STANDARD_DEVIATION .38 • n=18 Participants
|
.16 micrograms per deciliter
STANDARD_DEVIATION .11 • n=43 Participants
|
0.3 micrograms per deciliter
STANDARD_DEVIATION .3 • n=83 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6Participants 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 (week 1) and on the last day of the intervention (week 6) 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
Outcome measures
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Salivary Cortisol Levels
Post-Intervention: Last day of week 6
|
.33 micrograms per deciliter
Standard Deviation .2
|
.25 micrograms per deciliter
Standard Deviation .13
|
.15 micrograms per deciliter
Standard Deviation .11
|
|
Salivary Cortisol Levels
Pre-Intervention: First day of week 1
|
.30 micrograms per deciliter
Standard Deviation .40
|
.43 micrograms per deciliter
Standard Deviation .38
|
.16 micrograms per deciliter
Standard Deviation .11
|
PRIMARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6This 9 item questionnaire is designed to evaluate severity of depressive symptoms in participants. 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.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Patient Health Questionnaire
Pre-Intervention: First day of Week 1
|
11.84 score on a scale
Standard Deviation 7.02
|
6.47 score on a scale
Standard Deviation 4.60
|
7.1 score on a scale
Standard Deviation 4.8
|
|
Patient Health Questionnaire
Post-Intervention, last day of Week 6
|
8.67 score on a scale
Standard Deviation 5.86
|
4.92 score on a scale
Standard Deviation 4.69
|
4.5 score on a scale
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6This 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.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Generalized Anxiety Disorder-7 Anxiety Scale
Pre-Intervention: First day of Week 1
|
9.45 score on a scale
Standard Deviation 5.62
|
7.84 score on a scale
Standard Deviation 5.36
|
7.9 score on a scale
Standard Deviation 5.1
|
|
Generalized Anxiety Disorder-7 Anxiety Scale
Post-Intervention, last day of Week 6
|
8.22 score on a scale
Standard Deviation 4.57
|
6.06 score on a scale
Standard Deviation 5.02
|
5.4 score on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6Participants enrolled will have their heart rate data measured by the Biopac BioNomadix PPG \& EDA System with Pulse Transduce to determine heart rate variability. Due to circumstances beyond the research team's control, only teachers at one study site were able to provide heart rate variability data, so fewer than our total enrollment was able to provide this data.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=21 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=14 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=29 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Heart Rate Variability
Pre-Intervention: First day of Week 1
|
72.55 beats per minute (bpm)
Standard Deviation 13.27
|
70.29 beats per minute (bpm)
Standard Deviation 10.28
|
68.46 beats per minute (bpm)
Standard Deviation 11.00
|
|
Heart Rate Variability
Post-Intervention, last day of Week 6
|
73.34 beats per minute (bpm)
Standard Deviation 11.73
|
69.00 beats per minute (bpm)
Standard Deviation 8.85
|
70.87 beats per minute (bpm)
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6The 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. The minimum score possible is a 0 and the maximum score is a 40. A higher score indicates an improvement (increased resilience).
Outcome measures
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
Pre-Intervention: First day of Week 1
|
26.64 score on a scale
Standard Deviation 8.17
|
25.68 score on a scale
Standard Deviation 6.52
|
28.8 score on a scale
Standard Deviation 4.9
|
|
Connor-Davidson Resilience Scale (CD-RISC)
Post-Intervention, last day of Week 6
|
25.56 score on a scale
Standard Deviation 7.76
|
27.33 score on a scale
Standard Deviation 6.06
|
29.2 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6Teachers will complete this self-reporting scale consisting of 30 items measuring levels of compassion satisfaction, secondary trauma, and professional burnout. Respondents rate items on a 5 point Likert scale ranging from 0 (never) to 5 (very often). Scores within each subscale were added together to produce a mean for each subscale; subscale means were then averaged together for a total mean score. The minimum score for each subscale is a 0, and the maximum score for each subscale is a 50. Reduced scores indicate an improvement in burnout and secondary trauma.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Professional Quality of Life Index (Pro-QOL)
Pre-Intervention: First day of Week 1
|
32.6 score on a scale
Standard Deviation 5.27
|
—
|
—
|
|
Professional Quality of Life Index (Pro-QOL)
Post-Intervention, last day of Week 6
|
31.27 score on a scale
Standard Deviation 5.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6Teachers will complete this self-reporting scale consisting of 12 items measuring levels of self-perceived levels of impact on student engagement, instructional strategies, and classroom management. Respondents rate items on a 9 point Likert scale ranging from 0 (nothing) to 9 (a great deal). The minimum score possible is a 0 and the maximum score is a 90. Subscale scores were averaged together to produce a single mean. Higher mean scores indicate improvements in self-perceptions of self-efficacy.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
Teachers' Sense of Self-Efficacy (Short Form)
Pre-Intervention: First day of Week 1
|
83.2 score on a scale
Standard Deviation 11.8
|
—
|
—
|
|
Teachers' Sense of Self-Efficacy (Short Form)
Post-Intervention, last day of Week 6
|
81.5 score on a scale
Standard Deviation 12.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6Participants will complete this self-reporting scale consisting of 8 items measuring perceived levels of sleep quality over the previous 7 days. Items are scored on a Likert scale ranging from 1 (not at all) to 5 (very much). The minimum score possible is 8 and the maximum score is a 40. Lower scores indicate an improvement in sleep quality, and higher scores indicate increased severity of sleep disturbances.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=22 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
n=18 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
PROMIS Sleep Disturbance Scales
Pre-Intervention: First day of Week 1
|
22.27 score on a scale
Standard Deviation 2.80
|
23.00 score on a scale
Standard Deviation 3.18
|
22.1 score on a scale
Standard Deviation 2.9
|
|
PROMIS Sleep Disturbance Scales
Post-Intervention, last day of Week 6
|
23.39 score on a scale
Standard Deviation 3.45
|
22.28 score on a scale
Standard Deviation 2.47
|
21.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6Teachers will complete this self-reporting scale consisting of 20 items measuring traumatic stress symptoms in the previous month. Items are scored on a Likert scale from 0 (not at all) to 4 (extremely). The minimum score possible is a 0 and the maximum score is an 80. Lower scores indicate improvements in traumatic stress symptoms, and higher scores worsening levels of traumatic stress in respondents.
Outcome measures
| Measure |
High School Students: Remote Delivery
n=43 Participants
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
High School Students: Face-to-Face Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
Teachers: Remote Delivery
Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
|
|---|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Pre-Intervention: First day of Week 1
|
19.5 score on a scale
Standard Deviation 12.9
|
—
|
—
|
|
PTSD Checklist for DSM-5 (PCL-5)
Post-Intervention, last day of Week 6
|
12.8 score on a scale
Standard Deviation 10
|
—
|
—
|
Adverse Events
High School Students: Remote Delivery
High School Students: Face-to-Face Delivery
Teachers: Remote Delivery
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