Adults 13 to 85, any sex, with Trauma and Stressor Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Salivary Cortisol LevelsPrimary· Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6
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
Post-Intervention: Last day of week 6
Group
Value
95% CI
High School Students: Remote Delivery
.33
± .2
High School Students: Face-to-Face Delivery
.25
± .13
Teachers: Remote Delivery
.15
± .11
Pre-Intervention: First day of week 1
Group
Value
95% CI
High School Students: Remote Delivery
.30
± .40
High School Students: Face-to-Face Delivery
.43
± .38
Teachers: Remote Delivery
.16
± .11
Patient Health QuestionnairePrimary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
This 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
High School Students: Remote Delivery
11.84
± 7.02
High School Students: Face-to-Face Delivery
6.47
± 4.60
Teachers: Remote Delivery
7.1
± 4.8
Post-Intervention, last day of Week 6
Group
Value
95% CI
High School Students: Remote Delivery
8.67
± 5.86
High School Students: Face-to-Face Delivery
4.92
± 4.69
Teachers: Remote Delivery
4.5
± 3.6
Generalized Anxiety Disorder-7 Anxiety ScalePrimary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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 reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
High School Students: Remote Delivery
9.45
± 5.62
High School Students: Face-to-Face Delivery
7.84
± 5.36
Teachers: Remote Delivery
7.9
± 5.1
Post-Intervention, last day of Week 6
Group
Value
95% CI
High School Students: Remote Delivery
8.22
± 4.57
High School Students: Face-to-Face Delivery
6.06
± 5.02
Teachers: Remote Delivery
5.4
± 4.4
Heart Rate VariabilityPrimary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Participants 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
High School Students: Remote Delivery
72.55
± 13.27
High School Students: Face-to-Face Delivery
70.29
± 10.28
Teachers: Remote Delivery
68.46
± 11.00
Post-Intervention, last day of Week 6
Group
Value
95% CI
High School Students: Remote Delivery
73.34
± 11.73
High School Students: Face-to-Face Delivery
69.00
± 8.85
Teachers: Remote Delivery
70.87
± 12.41
Connor-Davidson Resilience Scale (CD-RISC)Secondary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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. The minimum score possible is a 0 and the maximum score is a 40. A higher score indicates an improvement (increased resilience).
Pre-Intervention: First day of Week 1
Group
Value
95% CI
High School Students: Remote Delivery
26.64
± 8.17
High School Students: Face-to-Face Delivery
25.68
± 6.52
Teachers: Remote Delivery
28.8
± 4.9
Post-Intervention, last day of Week 6
Group
Value
95% CI
High School Students: Remote Delivery
25.56
± 7.76
High School Students: Face-to-Face Delivery
27.33
± 6.06
Teachers: Remote Delivery
29.2
± 4.3
Professional Quality of Life Index (Pro-QOL)Secondary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Teachers 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
Teachers: Remote Delivery
32.6
± 5.27
Post-Intervention, last day of Week 6
Group
Value
95% CI
Teachers: Remote Delivery
31.27
± 5.07
Teachers' Sense of Self-Efficacy (Short Form)Secondary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Teachers 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
Teachers: Remote Delivery
83.2
± 11.8
Post-Intervention, last day of Week 6
Group
Value
95% CI
Teachers: Remote Delivery
81.5
± 12.4
PROMIS Sleep Disturbance ScalesSecondary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Participants 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
High School Students: Remote Delivery
22.27
± 2.80
High School Students: Face-to-Face Delivery
23.00
± 3.18
Teachers: Remote Delivery
22.1
± 2.9
Post-Intervention, last day of Week 6
Group
Value
95% CI
High School Students: Remote Delivery
23.39
± 3.45
High School Students: Face-to-Face Delivery
22.28
± 2.47
Teachers: Remote Delivery
21.2
± 2.9
PTSD Checklist for DSM-5 (PCL-5)Secondary· Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Teachers 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.
Pre-Intervention: First day of Week 1
Group
Value
95% CI
Teachers: Remote Delivery
19.5
± 12.9
Post-Intervention, last day of Week 6
Group
Value
95% CI
Teachers: Remote Delivery
12.8
± 10
Sponsor's own description
Compared to U.S. urban counterparts, rural residents face major barriers to using health care services. Challenges include shortages of services, long distances to existing services, and stigma regarding mental illness in isolated communities. These difficulties hold true for Montana, but especially for adolescents. The objective of A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana is to improve stress-related mental and physical health outcomes for adolescents and educators in rural Montana through school-based, trauma-informed yoga exercises. This project builds on investigators' previous research (including a two-year CAIRHE pilot study, 2019-21) to promote positive youth development by simultaneously intervening with students and teachers with a trauma-informed yoga intervention. Geographic isolation and resulting lack of resources for many Montanan schools indicates a need for novel, school-centered interventions to address the needs of rural adolescents; yoga can benefit youth and teacher wellbeing.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05085392 — A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
· NA
· completed
NCT04664855 — A Trauma-Informed Approach for Positive Youth Development for Montana Students
· NA
· completed
NCT04234425 — A Trauma-Informed Approach for Positive Youth Development for Montana Students
· NA
· completed
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montana State University
Last refreshed: 26 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05844007.