A Trauma-Informed Approach for Positive Youth Development for Montana Students
Phase: NA
Conditions: Depression, Anxiety, Suicidal Ideation, Stress, Trauma
Sponsor: Montana State University

 
 
 
 
 
 
 
 
 
 
 
A Trauma-Informed Approach for Positive Youth Development for Montana Students 
Dr. Lauren Davis 
September 7, 2021 
Clinical Trial # NCT04664855 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
The second year of “A Trauma-Informed Approach for Positive Youth Development for 
Montana Students” will continue in the same format as winter 2020, but with 35 participants in 
an experimental group, along with 20 students in a control group within the same school and 
enrolled in classes by the same physical education teacher. District leaders wish to hold the 
study during the Jan-March 2021 window, as this timeframe has shown a historical spike in 
inappropriate student behaviors and absenteeism.  Twice weekly 45-minute sessions during the 
8-week intervention period will occur within two physical education classes in order to draw 
enough participants to gauge statistical significance with resulting data; a third physical 
education class with the same teacher will serve as the control group for the study, therefore 
creating 3 gym class clusters, which will allow for computer-generated randomization. Instead of 
individuals being randomly assigned, gym class clusters of individuals will by randomly allocated 
to intervention groups. Control group participants will also be offered 8 weeks of yoga after the 
study concludes. 
Student incentives for at least a 75% attendance record in the experimental group include 
receiving a Fitbit Inspire HR for the study to track their physical health data and students will 
retain these to encourage healthy exercise and sleep patterns following the study.  Teacher 
incentives for completion of surveys include classroom supply money (funneled through school 
administration).  Gift cards will be provided to parents/guardians who complete the surveys 
about their child; these will be disseminated by school officials for parents to pick up at the high 
school, or they may be mailed by the PI on request.  Control group participants will also each 
receive Fitbit Inspire HR upon completion of all pre- and post-survey measures as an incentive. 
Data will be collected in a way to best protect student privacy and confidentiality; all surveys 
will request that participants self-identify through a confidential code provided by the PI, and all 
reflective journals will be labeled with this code as well. Cortisol tubes will also be labeled with 
this unique code.  The PI will maintain the code key in an encrypted computer file, which can 
only be unlocked with an access code that is known only by the PI; this computer will be kept in 
a locked office at all times, and all data will be securely destroyed (either by computer deletion 
or secure shredding) no later than one year after the conclusion of the study. 
The intervention might bring up strong emotions for the participants; so too might the 
administration of the ACE survey during preliminary data collection.  To mitigate this potential, 
the PI will caution students that this may occur and emphasize the importance of self-care and 
knowing one’s own limits. Immediate referrals regarding suicidality, self-harm, depressive 
thoughts, etc. will be directed to the school nurse.  If needed, referrals for additional, outside 
treatment will be provided as determined by school officials and/or requested by the participant 
and/or the participant’s legal guardian(s).  Additional resources for outside assistance will be 
shared with participants; these resources, along with processes for reporting and responding to 
adverse outcomes, can be found in the study’s Human Subjects form and on student assent 
and parent consent forms.  
Participants in this feasibility study may have reductions in severity of depression and/or anxiety 
as well as improvements in overall behavioral health and well-being. If needed, referrals for 
additional, outside treatment will be provided, as determined by school officials and/or 
requested by the participant and/or the participant’s legal guardian(s).  Benefits also include vital 
data to inform other potential interventions. 

Aim 1: Pilot test a trauma-informed yoga intervention for 15-18 year-old male and female high 
school students. 
To prepare for pilot study year 2, feedback has been gathered from the school district, 
teachers, and students via focus groups and email communications to assess the burden from 
the various assessment instruments and participation in the pilot.  Assessment measures listed 
below comport with this feedback.  Retention and satisfaction of participants, as measured by 
survey instrumentation from year 1 has indicated the need for an ongoing partnership with the 
school district and an expansion to additional high school physical education classes (8-week 
intervention, n=35).  During year 2, the study will compare results between the experimental 
group and a new 20-participant control group, which will be located within the same school 
setting.  The intervention’s effectiveness for youth mental and physical health will be assessed 
with: surveys measuring depressive and anxiety symptomology; and a wearable fitness tracker 
(added in year 2) with cortisol testing to measure physiological changes (e.g., resting heart rate 
and sleep cycle patterns). 
Aim 2: We will implement a limited feasibility study of partial online yoga delivery via Zoom 
within the context of the pilot study’s physical education classes to explore scalability to rural 
communities without access to yoga instructors as well as provide a contingency for COVID-19 
school closures.   
One session will be held during the PE class period with the yoga instructor teaching remotely 
to the entire class; another will be held outside of the regular school day with participants 
attending synchronously from home at a time to be determined by surveying participants’ 
preferences and availability; both sessions will have a 75% participation rate goal. Qualitative 
feedback will be gathered from both the yoga instructor and participants on their remote 
experiences.  Remote delivery will also be provided for the control group following the 
conclusion of the study. 
Aim 3: Evaluate the study’s school-community-academic partnership at the conclusion of the 
program using a mixed methods survey.  The results will be compared using paired t tests with 
data from the same survey, collected at the end of year 1.  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 with a year 3 expansion.  
 
Sources of Materials. Assessment measures will include the following: 
Description of Measure 
Source (if 
applicable) 
Timeline for 
Dissemination 
Cronbach’s 
Alpha/Validity & 
Reliability 
Center for Youth Wellness 
ACE-Q Self-Reporting 
Screener for Teens 
Burke-Harris 
& Renschler, 
2015 
Pre-intervention (in order to 
determine ACE scores of 
participants) 
Longitudinal testing 
currently underway to 
measure content and 
construct 
validity/reliability 
Generalized Anxiety Disorder 
Scale (GAD-7) 
Spitzer et al., 
2006 
Pre- and post-intervention 
Cronbach's alpha: .79-
.91 
Reliability = .85 

Validity = 73.3% 
Patient Health Questionnaire 
for Depressive Symptomology 
for Adolescents (PHQ-A) 
Johnson, 
2002 
Pre- and post-intervention 
Chronbach’s alpha = 
.835 
Reliability = .875 
Validity = 89.5% 
Strengths and Difficulties 
Questionnaire for ages 11-17 
(SDQ Self-Report 11-17), 
Teachers and Parents Report 
(SDQ-Teacher/Parent Report 
11-17)  
Goodman, 
2005 
Pre- and post-intervention 
Chronbach’s alpha = 
.86 
Reliability and validity 
vary according to 
respondent type and 
age of child self-
reporting  
Cortisol salivary assays 
Salimetrics 
Laboratories 
Pre (beginning of week 1)-, 
mid- (week 4) and post-
intervention (end of week 8) 
Mean accuracy of 
salivary cortisol testing 
> 90% 
Resting heart rate and sleep 
cycle data (collected from the 
wearable fitness tracker, Fitbit 
Inspire HR) 
Fitabase 
Cloud-Based 
Data 
Management 
System 
Pre- (1 week prior to 
intervention to establish a 
baseline), mid- (week 4) 
and post-intervention (at 
conclusion of week 8) 
(collected through cloud-
based data management 
system, Fitabase) 
Heart rate measure = 
mean margin of error 
5.96% and mean 
agreement of 91% 
with ECG data 
Sleep: Cohen’s kappa 
0.52-0.53 +/- 0.14; 
per-epoch accuracy of 
69% 
Collection of secondary data, 
including attendance and 
academic data (MAPS 
benchmark/progress 
monitoring standardized 
assessment scores, 
attendance, and office 
referrals)   
 
N/A 
Office referrals/behavioral 
data: Collected 8 weeks 
prior to study and during 8 
weeks of intervention for 
comparison 
Attendance data: Collected 
8 weeks prior to study and 
during 8 weeks of 
intervention for comparison  
MAPS: Pre- and post-
intervention 
MAPS Data: Pearson 
correlation coefficients 
range from .76-.82 in 
reading and .82-.86 in 
mathematics 
 
Other measures: N/A 
 
Statistical Analysis Plan 
Gym class clusters of individuals will by randomly allocated to intervention groups. This 
approach is necessary because randomization at the individual level is impractical and we strive 
to avoid contamination between treatment groups. The responses from individuals within a 
cluster are likely to be more similar than those from different clusters because individuals within 
a will share a common yoga class experience. This lack of independence introduces complexity 
to the design and analysis. The degree of similarity, or clustering, will be quantified and reported 
using the intracluster correlation coefficient (ICC). When the ICC is low, individual observations 
contribute nearly equally to the analysis. (38). For all participants, baseline surveys (see table 
above) will be conducted prior to exposure to Yoga (T0). Follow-up surveys will be collected at 8 
weeks (T1). Analyses will be conducted using R Version 3.6. Baseline differences between 
intervention and control group will be examined using independent t test or χ2 test. All data will 
be analyzed according to treatment assignment. Two strategies will estimate treatment effects: 
1) Cluster level analysis using summary measures; and 2) Individual level analysis adjusted for 
clustering to appropriately account for the nested structure of data and cluster randomization in 

estimating. For the first, we will measure mean outcomes by cluster followed by parametric t-
tests or non-parametric tests, depending on the distributions of the outcome measures.  To 
account for the variability between gym classes and nested structure of the data, multilevel 
mixed-effects models will be used for each continuous outcome, with time (T0 & T1) as level 1, 
students as level 2, and class as level 3. To adjust for baseline pre-treatment values, 
explanatory variables for each outcome will include grade, gender, prior exposure to yoga at the 
high school, and survey time point (model 1). To assess the intervention’s effect on outcomes, 
we will use condition (intervention or control) and the interaction between condition and time as 
predictors (model 2). Effect sizes (ESs) will be calculated as (estimated intervention 
effect)/√(variance at student level). Interpretation of ES will determine the gains of the 
intervention versus control group. To calculate power for this cluster randomized trials that 
compares two means, we used the “clusterPower” package in R (24). Accounting for clustered 
design effects, 55 participants with variation in cluster sizes, an assumed low intraclass 
correlation of 0.001, and within-cluster variation of 5 units, this would provide at least 65% 
power to detect clinically meaningful effects between the treatment and control arm using two-
sided tests at alpha=0.051. To maximize test power and precision of estimation considering the 
few clusters in this study, we will also use wild cluster bootstrap-t procedure it to correct our 
standard errors (9, 47).  
A proxy for improved well-being, secondary academic performance outcomes, will also be 
analyzed descriptively pre- (during week 1) and post-intervention (at the end of week 8) (see 
table above). 
Physical Health Measures. 
Participants enrolled will have their resting heart rate and restorative sleep data tracked and 
assessed using their Fitbit Inspire HR wristbands.  They will be instructed to begin wearing their 
Fitbit for 1 week prior to starting the intervention to establish baseline data for sleep cycles and 
resting heart rates; this will also allow the PI to monitor daily data collection to ensure all devices 
are recording properly and address malfunctions and/or user error prior to the intervention.  
Once the intervention has begun, the PI will asynchronously and wirelessly connect to their 
Fitbit data using the Fitabase cloud-based data management platform once weekly to track any 
changes in duration and quality of restorative sleep and changes in resting heart rate.   
Salivary Cortisol Assays. 
Students in both the experimental and control groups will be administered cortisol testing at 
the beginning of weeks 1 and 4 and the conclusion of week 8, each time prior to the yoga 
session (or at the beginning of their physical education class, if in the control group).  
Specifically, students will provide a saliva sample to the school nurse or PI, to be deidentified 
(using a code key system) before analysis by the CAIRHE Translational Biomarkers Core Lab at 
MSU. Testing will use the Abcam (ab154996) cortisol in vitro competitive ELISA (Enzyme-
Linked Immunosorbent Assay) kit designed for accurate quantitative measurement of cortisol in 
saliva (sensitivity 0.12 ng/ml). Deidentified cortisol data will be returned to the PI for re-
identification using the code key.  Comparisons using paired t tests will assess trends and 
determine usefulness of this measure.   
 
1 If we increase α to 0.1, we can reduce the probability of a Type II error and increase our power to 0.86 but we are 
also more likely to commit a Type I error (rejecting a true null hypothesis). 
 

Using deidentified participant codes (with the PI retaining access to the code key system), 
data will be triangulated through observational data, qualitative remarks in participant journals, 
pre- and post-survey data, heart rate and sleep cycle data, cortisol analyses, and secondary 
academic and behavioral data.   
Control Group. 
Volunteers will participate in a separate physical education class for 8 weeks and will 
undergo testing as described above, with an opportunity to participate in yoga after T1.