Evaluation of a Work-Family and Sleep Leadership Intervention in the Oregon National Guard: A Behavioral Health Leadership Approach
Phase: NA
Conditions: Well-Being, Sleep, Health Behavior
Sponsor: Oregon Health and Science University

 
 
 
 
Evaluation of a Work-Family and Sleep 
Leadership Intervention in the Oregon 
National Guard: A Behavioral Health 
Leadership Approach 
NCT02946736 
LAST APPROVAL DATE: 21-MARCH-2023 

OHSU IRB #16555 
Study Protocol 
Version 4 
October 29, 2020 
 p.1 
 
(1) Protocol Full Title 
Evaluation of a Work-Family and Sleep Leadership Intervention in the Oregon National Guard: 
A Behavioral Health Leadership Approach 
 
Short Title 
Oregon Military Employee Sleep and Health (MESH) Study 
 
Principal Investigator 
Dr. Leslie Hammer (Oregon Institute of Occupational Health Sciences) 
 
Brief Description 
The current project is funded by the Department of Defense (PPQ # is 1008990; sponsor 
funding ID is PT150133; DoD contract # is W81XWH-16-1-0720). This study is a randomized 
controlled trial that will assess the effects of (1) the Family-Supportive Supervisor Behavior 
(FSSB) and Sleep Leadership training and (2) sleep/cognitive effectiveness feedback 
intervention on health and well-being among full-time employees in the Oregon National Guard, 
their supervisors, and their families. The interventions involving both health protection and 
health promotion are expected to contribute to improvements in employees’ and their 
supervisors' sleep, risk behaviors, mental and physical health, and injury, as well as employees’ 
and their spouse/partners' family experiences, health and well-being, and workplace outcomes. 
 
(2) Objectives 
The current study aims to improve health and well-being among full-time employees (including 
Military Technicians and Active Guard Reserves) in the Oregon National Guard (Army and Air 
Guard), their supervisors, and their families. The research team will adopt a comprehensive and 
integrative approach that is designed to have an impact on multiple risk behaviors and health 
outcomes. The primary goal of the proposed randomized controlled trial is to develop and test 
the effectiveness of (1) a Family-Supportive Supervisor Behavior (FSSB)/Sleep Leadership 
training intervention designed for supervisors (i.e., health protection at the supervisor level) and 
(2) an individual-level intervention for both supervisors and employees using actigraphic sleep 
tracking and cognitive effectiveness feedback (i.e., health promotion at the individual level).  
 
Some of the expected intervention outcomes are reduction in risk behaviors, as well as 
improved physical and psychological health, and workplace outcomes among full-time 
employees within the context of the Oregon National Guard (Army and Air Guard), as well as 
their supervisors and their spouses/partners. Additionally, the current study adopts a waitlist-
control experimental design for the FSSB/Sleep Leadership training, so the training will be made 
available to all location clusters in the control group that are interested; the wait-list control 
group will receive the individual-level actigraphic feedback intervention after the final data 
collection. 
 
The primary hypotheses and research questions involve assessing the effects of the (1) Family-
Supportive Supervisor Behavior (FSSB)/Sleep Leadership training and the (2) sleep/cognitive 
effectiveness feedback intervention on: 
• 
Employees’ and their supervisors’ sleep (self-report and actigraphy measures), risk 
behaviors (e.g., drinking, smoking, and unsafe driving), mental and physical health (e.g., 
physical symptoms, functional impairment, PTSD symptoms, and depressive 
symptoms), and injury 

OHSU IRB #16555 
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• 
Employees’ and their spouse/partners’ global family processes (e.g., marital 
satisfaction), and spouse/partners’ mental and physical health (e.g., physical symptoms, 
self-reported indicators of stress, functional impairment, and depressive symptoms) 
• 
Employee, supervisor, and spouse/partner workplace outcomes (e.g., job satisfaction, 
organizational commitment, absenteeism, and occupational safety/injuries) 
 
(3) Background 
This study utilizes multiple interventional components to achieve the targeted outcomes. 
Specifically, the current study adopts an integrative approach to improving health and well-being 
among full-time employees in the Oregon National Guard, their supervisors, and their families, 
as well as their overall experiences at work. The integrative and systems-level approach 
involves both health protection and health promotion strategies, and it has been shown in the 
occupational health literature to be particularly effective at improving employee health and well-
being. For health protection, the current study builds on, and extends, prior research in the 
civilian workforce with FSSB and Veteran-Supportive Supervisor Training (VSST). Elements of 
these two training programs will be integrated to develop an FSSB/Sleep Leadership training 
program for supervisors in the Oregon National Guard. The FSSB training was first developed 
by Dr. Hammer (PI in current protocol) and her colleague Dr. Ellen Kossek as part of their 
research with the Work, Family & Health Network (WFHN) study funded by the National Institute 
of Occupational Safety and Health (NIOSH). The research team has found significant 
intervention effects in previous FSSB training studies. FSSB training was also used as the basis 
for the development of the VSST intervention that is currently implemented in the Study of 
Employment Retention for Veterans (SERVe) project (PI: Dr. Leslie Hammer; IRB #0009369).  
 
The research team will extend these previously-developed supervisor training interventions 
focused on increasing supervisor support for family and increasing civilian supervisor support 
for Service members to a military setting and specifically the National Guard and Reserves. The 
current training program also draws on the Behavioral Health Leadership concept, specifically 
Sleep Leadership, which aims to increase supervisor support for better sleep outcomes. In other 
words, sleep leadership refers to leader behaviors that are focused on improving and promoting 
good sleep patterns and environmental conditions for employees. By modifying this existing 
workplace training intervention and testing the specific effects within military units, we expect to 
see improved health and well-being among full-time Oregon National Guard employees and 
their families. This training intervention will eventually have the opportunity to be extended and 
widely implemented among our active duty military population, thus further informing evidence-
based family-supportive policies across military settings, as well as improving health and well-
being among Service members, their supervisors, and their families. 
 
In addition to the supervisor FSSB/Sleep Leadership training, the current study includes an 
individual-level health promotion component which provides employees and their supervisors 
with sleep monitoring using actigraphy devices (Phillips Actiwatch 2) and in-person 
sleep/cognitive effectiveness feedback based on their daily sleep measurements (see Appendix 
A for a sample feedback report). The feedback will highlight and is expected to increase 
employees’ and their supervisors’ awareness of their daily activity and sleep/wake scoring, 
summary sleep data comparisons, cognitive effectiveness estimates derived from the sleep 
data, and recommended actions for improving sleep quality. The increased awareness of their 
sleep patterns and the actionable recommendations provided to improve their sleep are 
expected to encourage behavioral changes and ultimately result in more positive sleep, health, 

OHSU IRB #16555 
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October 29, 2020 
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and well-being outcomes. Because the research team has been successful with the supervisory 
training for FSSB in previous work, we anticipate that intervention effects on the targeted 
outcomes will be replicated in this study and even strengthened, given the integration of Sleep 
Leadership training elements and the addition of individual-level sleep/cognitive effectiveness 
feedback. Given that research on the effectiveness of actigraphic feedback is very limited, we 
seek to extend the literature by investigating how actigraphic feedback would change/improve 
subsequent outcomes related to sleep, health, and well-being among employees, their 
supervisors, and their spouses/partners. 
 
(4) Study Design 
This is an intervention study involving full-time employees at the Oregon National Guard 
(ORNG), their supervisors, and their spouses/partners. We are using an RCT approach to 
evaluate the intervention, specifically, a cluster-randomized (clustered by unit locations) pre-test 
post-test design. We will collect data from a minimum of 500 full-time employees, as well as 
their supervisors (about 200 supervisors). We will also recruit spouses and partners of those 
ORNG employees who are married/partnered to participate in this study. ORNG armories and 
facilities (field maintenance shops or headquarters), sometimes broken down to smaller units 
within those locations, will be randomly assigned to the intervention (training) and control 
groups. To accommodate multiple geographic locations and to build some flexibility into the 
timing of the training, we will have a phased roll out of the study. A phased roll-out can also 
maximize participant recruitment and retention in order to achieve the target sample size. 
Randomization of treatment groups will also occur through this grouping (i.e., cluster 
randomization). 
 
The flow chart below illustrates the different project stages and the overall study design. The “N” 
numbers refer to the target sample sizes.  
 
Baseline 
Supervisors (“Sup”), employees (“Emp”), and employees’ spouses/partners in both 
training/intervention and control groups will first complete a survey (see Appendix B for survey 
measures to be completed by each group and see supporting document for the list of survey 
items that we will select from) during the baseline period. In the meantime (during baseline), 
supervisors and employees will also be asked to wear actigraphy watches for 3 weeks as part of 
our sleep data collection and preparation for in-person sleep feedback. We will be using the 
Phillips Actiwatch 2 actigraphy device - 
http://www.usa.philips.com/healthcare/product/HC1044809/actiwatch-2-activity-monitor.  
 
When we distribute the watches to participants, we will verbally ask them to answer four 
questions regarding 1) their drill or annual training dates and locations in the next 3 weeks, 2) 
major events that may disrupt their sleep in the next 3 weeks, 3) other noteworthy factors that 
may affect their sleep in the next 3 weeks, and 4) any time where they might need to temporarily 
take off the actigraph watches for security and/or safety reasons. The full list of actigraph 
delivery questions can be found in the supporting document. Responses to these questions will 
be used for data quality control/management and for contextualizing actigraphic data. 
 
Intervention 
The intervention phase begins approximately one month after baseline. For supervisors in the 
training/intervention groups, the intervention will include a computer/web-based supervisor 

OHSU IRB #16555 
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training integrating concepts from Behavioral Health Leadership, Sleep Leadership Training, 
and the VSST/FSSB training mentioned above. Participation in this computer-based supervisor 
training is mandated by the Oregon National Guard leadership. Additionally, supervisors in the 
training/intervention group will be provided individual-level sleep/cognitive effectiveness 
feedback based on the actigraph data collected during baseline, and this feedback will be 
provided to the supervisors in person (see Appendix A for a sample feedback report).  
 
For employees in the training/intervention groups, they will also receive an in-person 
sleep/cognitive effectiveness feedback report based on the actigraph data collected during 
baseline. During the intervention phase, spouses in the training/intervention groups and 
everyone in the control groups will not be recruited for any research activity and/or data 
collection. 
 
4-month post-baseline 
At 4-month post-baseline, employees, their supervisors, and their spouses/partners in both 
training/intervention and control groups will be asked to complete an online survey (see 
Appendix B for survey measures to be completed by each group and see supporting document 
for the list of survey items that we will select from).  
 
9-month post-baseline 
At 9-month post-baseline, we will repeat the procedure conducted during the baseline period - 
where supervisors, employees, and their spouses/partners in both training/intervention and 
control groups will be asked to complete an online survey (see Appendix B for survey measures 
to be completed by each group and see supporting document for the list of survey items that we 
will select from), and in the meantime, supervisors and employees will be asked to wear 
actigraphy watches for 3 weeks as part of our sleep outcome data collection.  
 
When we collect the watches from participants after 3 weeks of actigraph wearing, we will 
verbally ask them to answer four questions regarding 1) their drill or annual training dates and 
locations in the past 3 weeks, 2) major events that disrupted their sleep in the past 3 weeks, 3) 
other noteworthy factors that affected their sleep in the past 3 weeks, and 4) any time where 
they had to temporarily take off the actigraph watches for security and/or safety reasons. The 
full list of actigraph delivery questions can be found in the supporting document. Responses to 
these questions will be used for data quality control/management and for contextualizing 
actigraphic data. 
 
While participation in the computer-based FSSB/Sleep Leadership supervisor training is 
mandated by the Oregon National Guard leadership, participation in surveys and actigraph 
sleep/activity tracking is completely voluntary and is not mandated by the Oregon National 
Guard leadership. 
 
Waitlist-control intervention (No data collection involved) 
Upon completion of data collection, supervisors in the control groups will receive the computer-
based FSSB/Sleep Leadership training. Additionally, we will use the actigraph data collected 
from baseline and 9-month post-baseline to generate feedback reports (e.g., comparison 
estimates) for all participants in both intervention and control groups. These reports will only be 
used for feedback purposes, they are not part of the intervention.  
 

OHSU IRB #16555 
Study Protocol 
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The actigraph data collected from baseline and 9-month post-baseline will also be used for our 
internal data analyses (e.g., combined with survey responses for statistical analyses and 
hypothesis testing). Note that the current study is simply using the actigraphy devices to collect 
data related to participants’ sleep and their daily activities. We are not testing the efficacy of the 
devices. 
 
 
COVID-related Supplement:  Survey data collection 
 
Due to the extraordinary circumstances of the global novel coronavirus pandemic in 2020, we 
requested and received funding to collect an additional wave of survey data (no actigraphy) 
from all participants who responded at baseline, service members, supervisors and 
spouse/partners, using REDCap. We will remind participants that they previously provided 
consent when responding to the initial survey and reiterate that their participation here is 
voluntary. We will repeat the majority of the previous survey, with some exceptions, as well as 
the addition of several COVD-related items. The potential additional items have been added to 
Appendix B. Please note this list of items may be shortened but no additional items will be 
added at this time. 
Overall, the process will be the same as with the 4-month data collection where the survey will 
be emailed to participants with no in-person contact.    All surveys will be sent at one time in 
November 2020, regardless of when they completed their last survey; we will calculate that time 
lag and account for it in our analyses. 
 
 
We will send the survey to the personal email that the participant previously provided with the 
instructions to complete OFF work time. To reduce the response burden on the participant, we 
will pipe in some information, including name, email, rank, work status, etc., and ask them if the 
information is still accurate and provide them an opportunity to update if needed. We will ask for 
electronic consent for this survey

OHSU IRB #16555 
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Baseline 
-Survey & 
Actigraphy 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
9 Mos post 
BL 
-Survey & 
Actigraphy 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
COVID 
focus 
survey 
-Survey only 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
4 Mos post 
BL 
-Survey only 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
Intervention 
-Supervisor 
Training 
-Sleep 
Feedback 
Control 
-Usual 
Practice 
Raqndomization

7 
 
(5) Study Population 
Number of Subjects 
We anticipate recruiting approximately 500 full-time employees (Military Technicians and Active 
Guard Reserves) in the Oregon National Guard –Army and Air - and their supervisors to 
participate in the study. Given each supervisor oversees 5 or more employees, we anticipate 
recruiting at least 150 of the 180 first-level supervisors to participate in the study and take part in 
the FSSB/Sleep Leadership training intervention. We anticipate another 50 second-level 
supervisors to also participate in the study. Therefore, we expect to recruit a total of 500 
employees and 200 supervisors into the study – they will be randomized by location cluster 
into the intervention and control conditions. Of the 500 full-time employees we will recruit, we 
expect that approximately 80% (400) of the employees will be married and/or cohabitating – 
based on our prior work with the SERVe study. All employee spouses/partners (anticipated 
number of 260 spouses/partners) will also be invited to complete surveys that coincide with the 
employee surveys, pre- and post-intervention (i.e., baseline, 4-month and 9-month post-
baseline). Personnel at the OHSU site will be responsible for all participant recruitment.  
 
Inclusion & Exclusion Criteria 
To be eligible for this study, a participant must be 18 years old, currently employed as a full-time 
Military Technician or Active Guard Reserve in the state of Oregon and working at least 32 
hours per week. Already inherent with employment as a Military Technician and an Active 
Guard Reserve a participant must be at least 18 years old and work full-time. In the unlikely 
circumstance that a screen failure occurs (i.e., participants do not meet our inclusion criteria), 
their data will be retained for separate analysis to determine if findings are different from those 
who meet the inclusion criteria. 
 
The Internet surveys will be developed and conducted via the REDCap program, which is 
monitored by the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU - 
https://octri.ohsu.edu/redcap/. According to OCTRI, “REDCap is a secure, reliable, versatile and 
feature-rich web application for building and managing HIPAA compliant online surveys and 
databases.”  
 
Vulnerable Populations 
No individuals who are known to be members of a vulnerable population will be enrolled. We will 
not identify subjects on whether they are members of a vulnerable population. In other words, 
we will not collect any information about subjects’ status as part of any vulnerable populations, 
including prisoners, pregnant woman, children, neonates, and/or adults lacking capacity. 
 
Setting 
This is a multi-site study involving personnel/researchers at OHSU, Colorado State University 
(CSU), and Portland State University (PSU). OHSU will be the coordinating center for all 
research activities. OHSU personnel will be responsible for all stages of the research project, 
including recruitment at the Oregon National Guard facilities, consent processes, study 
procedures, interacting with study participants, data collection (primarily online surveys and 
actigraphs), data management, data analysis, and dissemination of findings. Surveys will be 
conducted online on REDCap, OFF work time. Personnel at CSU and PSU will assist with 
training development, making recommendations for survey measures, data analysis and 
dissemination of findings. Specifically, personnel at CSU (PI of sub-award: Dr. Tori Crain) will 
assist with reviewing the sleep leadership training materials, making suggestions for sleep-
related survey measures, conducting actigraphy analyses, generating sleep feedback, analyzing 
data on intervention effects, and disseminating the study findings (e.g., peer-reviewed 
publications). Personnel at PSU (PI of sub-award: Dr. Cynthia Mohr) will assist with reviewing 

8 
 
supervisor training materials, making suggestions for family/spouse-related survey measures, 
assisting with dyadic-related statistical analyses, and disseminating study findings. IRB offices 
at CSU and PSU have ceded oversight to OHSU IRB. The ceding letters have been approved 
by OHSU on 1/23/2017 (reference ID: MOD00005655).  
 
OHSU personnel will also be working closely with Major Matthew LoPresti, Ph.D. at Walter 
Reed Army Institute of Research (WRAIR). He will serve as a consultant on study design, sleep 
leadership training development, and actigraphic data collection and analysis. WRAIR will also 
provide an inventory (about 200) of actigraph watches (Actiwatch 2) and accessories for data 
collection (e.g., docking stations, licenses, watchbands), provide consultation and training on 
actigraph utilization, data collection, data management, data analysis and interpretation. Dr. 
LoPresti will only have access to de-identified data upon completion of data collection; they will 
not interact with any human subjects. A formal cooperative research and development 
agreement (CRADA) has been fully executed that covers the loaning of actigraphy watches 
from WRAIR to our research team and to include Dr. LoPresti’s unpaid consultation and 
contract with de-identified data.  
 
Kathleen Carlson, an assistant professor at OHSU and a core-investigator at the Portland VA 
Medical Center, is a co-investigator of the project. She will not use VA time or VA resources to 
work on this project. 
 
Recruitment Methods 
The Chief of Staff with the Oregon National Guard (ORNG), COL Stuart Mathew, will facilitate 
our introduction to work sites in locations around the state of Oregon, including the Portland 
area, the state capitol of Salem, and Klamath Falls, where a large Air National Guard base, 
Kingsley Field, is located. OHSU research staff will visit all locations to first meet with top 
leadership to explain the goals of the project, answer questions, and get buy-in. We will develop 
a customized timeline and recruitment process for the site location, which will involve research 
staff visiting in person to introduce the study and invite interested employees to sign up for the 
study via secured web link that will be distributed to them in the recruitment materials (see 
supporting documents). We will distribute one page flyers and FAQs at each of the worksites to 
advertise the study and to explain the scope and purpose of our research. We will also work 
with the ORNG HR department to advertise our study via internal email messages sent by the 
Chief of Staff and senior leadership for that unit. All recruitment materials will include information 
regarding what participation would entail, contact information for questions and further 
information, as well as how to sign up to participate. Please refer to supporting documents for all 
recruitment materials.  
 
The recruitment materials above will be posted on-site approximately two months prior to 
baseline data collection. A small team of researchers will also visit the units in person during 
baseline period to do a final recruitment on site. Survey links will be emailed to participants’ 
personal email addresses upon signing up. Participants will be asked to complete the surveys 
*off* work time in order to receive compensation (per federal regulations). Our team will ensure 
that supervisors of employees are not present during this recruitment so as to not influence 
participation. We will also provide the actigraphy watches to the participant during our visit at 
baseline, along with instructions for wear.  
 
All spouses/partners who live with participating employees/supervisors will be invited to 
participate via the employee. Specifically, when a participant signs up, we will provide each 
employee/supervisor with information about the spouse/partner survey and ask if the 
employee/supervisor would either provide contact information for their spouse/partner or alert 

9 
 
the spouse/partner about the survey opportunity. We will also ask participating 
employees/supervisors to invite their spouses/partners to participate in this study after they 
complete the baseline survey and/or when we distribute the actigraphy watches in person. We 
will also post spouse-specific recruitment flyers, postcards and FAQs on-site during our visit to 
ORNG locations. After participating employees/supervisors complete the first survey, and after 
we receive the contact information (names and email addresses) of spouses/partners who 
express interest in participating in this study, we will send the spouses an email inviting them to 
sign up for the study and begin the first baseline survey. We will also have a phone number and 
email for spouses (and employees or supervisors) to reach out with any questions regarding the 
study. 
 
Of the 500 employees we will recruit, we anticipate that approximately 80% (400) of the 
employees will be married, engaged, and/or cohabiting, based on our prior work. Similarly, we 
have previously obtained response rates of about 50-65% for spouses and therefore, we expect 
that approximately 65% of those spouse/partners will agree to participate in the study (i.e., 260). 
We anticipate an 80% response rate at the 4-month and 9-month follow up for spouses (N=208 
and N=166, respectively). 
 
We will use incentives to aid recruitment of supervisors, employees, and spouse/partners. While 
we anticipate training supervisors during company time, we have found in our past 
organizational research experience that providing participant payment helps to increase 
participation. Thus, we plan on providing supervisors and employees a $50 incentive for 
completing a survey and wearing the actigraph watch during baseline and during 9-month post-
baseline, and a $25 incentive for completing a survey at 4-month post-baseline – thus they can 
earn up to $125 total ($50 baseline, $25 4-month post-baseline, and $50 9-month post-
baseline). Employees’ spouses/partners will be invited to complete three $25 surveys for 
baseline, 4-month post-baseline, and 9-month post-baseline, thus potentially earning up to $75 
total. These monetary incentives will be provided in ClinCards, which are reloadable debit cards, 
and they will be given to the participants subsequent to the completion of each time point 
(baseline, 4-month post-baseline and 9-month post-baseline). We will also provide food and 
beverages during on-site recruitment.  
 
Survey data will be collected via the REDCap program through a secured web link and off work 
time so as not to interfere with work and take up valuable work time. In addition, this makes 
employees eligible for the offered incentives, as federal regulations prohibit monetary incentives 
for surveys during regular work hours. In addition, all electronic communications, including the 
recruitment materials, surveys and training will be 508 compliant (i.e., accessible to those with 
disabilities following Federal guidelines). 
 
Consent Process 
Prior to any data collection, employees, their spouses, and their supervisors will be provided 
with informed consent (see attached informed consent forms). The same informed consent 
forms address data collection during baseline, 4-month post-baseline, and 9-month post-
baseline. At 4-month and 9-month post-baseline, we will provide participants with the same 
informed consent forms as baseline, and remind them about previous consent during baseline. 
We will also provide an option to save/print the consent forms at each time point. They will be 
told that their participation in data collection is voluntary and that all data will be kept confidential 
and not shared with their employer. We will ensure that employees’ commanders or supervisors 
are not present (during recruitment) when they sign up for our study in order not to be seen as 
coercive.  
 

10 
 
For the follow up COVID-focused survey in November 2020, we will provide a revised consent 
form that is specific to this survey. Per currently guidelines, we will provide the text of the 
consent form, and ask them to provide their electronic signature by selecting the appropriate 
box and typing in their first and last name.  
 
After they sign up for our study during recruitment, we will provide each participant a link to the 
online survey. A wavier of the HIPAA authorization signature requirement has been approved by 
the IRB. The informed consent will be at the very beginning of the online survey and participants 
will ‘click’ agree. They also have the option to download and print the informed consent. We will 
also have printed copies during our on-site visits (during baseline period) for those who may 
want to complete the online baseline survey at a later point in time. In addition, we provide 
participants with the phone number to our office, as well as the number for OHSU’s IRB, if they 
would like someone to read or go over the Informed Consent with them. 
 
Employees, their supervisors, and their spouses/partners will be informed that we are interested 
in understanding the employee’s experiences in the workplace and in the family as well as a 
number of sleep outcomes. As this is a waitlist-control experimental design, the same letters 
and consent forms will be used for both the intervention group and the control group. As such, 
those in the control group will eventually receive the intervention as well. 
 
Employees and supervisors will receive the same consent form for their voluntary participation 
in completing the surveys and wearing the actigraphs, as their involvement in these two study 
components is the same. Specifically, employees and supervisors will complete the same 
surveys (with one exception that participants who identify as supervisors will answer several 
additional supervisor-specific questions) and wear the same actigraphs for 3 weeks at baseline 
and at 9-month post-baseline. Both employees and supervisors in the treatment condition will 
also receive the same sleep feedback reports during the intervention phase. We will not 
differentiate between employees and supervisors until after baseline data collection and when 
we randomize our experimental conditions.  
 
The computer-based FSSB/Sleep Leadership training is mandated by ORNG leadership. Even 
though it is mandatory, we will be collecting consent from supervisors for the 
intervention/training data (including quiz data and behavioral self-tracking data), in particular, so 
we may use data from the supervisor computer-based training and link directly with survey 
responses of employees and their supervisors. There is a separate consent form for supervisors 
who are participating in this computer-based FSSB/Sleep Leadership training because not all 
supervisors who participate in this computer-based training are also participating in the survey 
and actigraphy portions of the study.  
 
Supervisors will receive the full consent and authorization form before being asked to provide 
consent to have their online training data used for research. To clarify, supervisors will complete 
the FSSB/sleep leadership training as part of their workplace training initiatives, but will have the 
voluntary option of allowing us to use their de-identified data in the evaluation of the training.  
 
 
 
 
 
 
 
 

11 
 
(6) Procedures Involved 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The current cluster-randomized study design involves baseline and two separate post-baseline 
measurements to test the effectiveness of the supervisor FSSB/Sleep Leadership training and 
sleep/cognitive feedback on a sample of full-time Oregon National Guard employees and 
supervisors. Supervisors of employees in the intervention/treatment condition will receive the 
supervisor FSSB/Sleep Leadership training at 1-month post-baseline. All supervisors, in both 
treatment and control conditions, will be invited to participate in the baseline and follow-up 
surveys (4-month and 9-month post-baseline) assessing their knowledge of FSSB and sleep 
leadership concepts, as well as assessing outcomes related to our study hypotheses. 
Additionally, employees and all their spouses/partners will be invited to participate in the survey 
study at baseline and both post-baseline follow-ups.  
 
The supervisor FSSB and Sleep Leadership training intervention is a computer/web-based 
training of supervisors – integrating concepts from Behavioral Health Leadership, Sleep 
Leadership, and the VSST/FSSB training described above. Sample screenshots of the 
supervisor training are presented in Appendix C. The training will be delivered to supervisors 
through a 1- to 2-hour, online, self-paced training consisting of multiple modules to be 
completed over the course of a pre-determined 2-week period of time. The training will occur 
approximately 1-month post-baseline data collection, which will include survey interviews and 
health assessments. Following completion of the computer/web-based training, supervisors will 
be instructed on how to implement a behavioral self-monitoring exercise using web-based 
behavior-tracking that will continue for 2 weeks and will enhance transfer of training into actual 
behaviors at work. The activity concludes with delivery of summary feedback and reflection on 
the training transfer experience. 
 
We will use a waitlist-control design where we will eventually make the FSSB and sleep 
leadership training available to all location clusters in the control group that are interested. Upon 
Baseline 
-Survey & 
Actigraphy 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
9 Mos post 
BL 
-Survey & 
Actigraphy 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
COVID 
focus 
survey 
-Survey only 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
4 Mos post 
BL 
-Survey only 
-Employee / 
Supervisor 
-Spouse/ 
Partner 
 
Intervention 
-Supervisor 
Training 
-Sleep 
Feedback 
Control 
-Usual 
Practice 
Raqndomization

12 
 
completion of data collection, we will also distribute sleep/cognitive effectiveness feedback 
reports to participants in both intervention and control groups. To accommodate multiple 
geographic locations, a limited number of actigraphy devices and to build some flexibility into 
the timing of the training, we will have a phased roll out of the study to last approximately 3 
years.  
 
We plan on taking a cluster, or group, randomization approach, or more specifically, a 
sequential cluster random assignment within Blocks (see Table below) to assign participants to 
treatment and control conditions. Based on the list of locations and units, we will identify 
approximately 24 clusters for the study, half to be randomized to the intervention group and half 
to control. Randomization will occur once units have been identified and before data collection. 
The research team recruiting and collecting data will be kept blind of the randomization results. 
 
Further clustering of facilities into groups of facilities is a second level of clustering. There are 
several reasons for this extra step. First, clustering facilities that are geographically close will 
help to minimize research-related travel expenses to the facilities because travel to several 
facilities in the same study intervention arm can be accomplished in one trip. Second, clustering 
facilities that are geographically close will help to minimize contamination across study 
intervention arms as geographically close facilities will tend to be assigned to the same 
intervention condition; furthermore, this may also serve to boost intervention effects as 
supervisors in intervention locations that are geographically close may talk with one another and 
share ideas and experiences. Third, creating clusters of facilities will help to balance better the 
number of employees across the study intervention conditions, an important issue given the 
variability in employees in facilities across the state.  
 
Based on our recruitment projections (500 employees, 200 supervisors), the table below breaks 
down the randomization numbers. Within each of 3 Blocks, there will be 8 total clusters, 
randomized into 4 treatment and 4 control. The cluster of 4 represents the second layer 
described in the paragraph above. Based on a preliminary roll out plan, we anticipate that Block 
2 will be slightly larger than Blocks 1 and 3. 
 
Randomization Design Plan 
 
Intervention 
Control 
Block 1 (begins 
Year 1) 
4 clusters of units 
• 
~ 75 employees across 
units (non-supervisor) 
• 
~ 30 supervisors 
4 clusters of units 
• 
~ 75 employees across units 
(non-supervisor) 
• 
~ 30 supervisors 
Block 2 (begins 
Year 2) 
 
4 clusters of locations 
• 
~ 100 employees across 
units (non-supervisor) 
• 
~ 40 supervisors 
4 clusters of locations 
• 
~ 100 employees across units 
(non-supervisor) 
• 
~ 40 supervisors 
Block 3 (begins 
Year 3) 
4 clusters of locations 
• 
~ 75 employees across 
units (non-supervisor) 
• 
~ 30 supervisors  
4 clusters of locations 
• 
~ 75 employees units (non-
supervisor) 
• 
~ 30 supervisors 
 
In addition to the supervisor FSSB/Sleep Leadership training, we will be providing a sleep-
related feedback intervention for employees and supervisors in the intervention group using 
actigraphy. Actigraphy represents a reliable and valid objective measure of sleep not used for 
the diagnosis of sleep disorders. Actigraphs, specifically Actiwatch 2 watches, are wristwatch-

13 
 
like devices that contain an accelerometer, continuously measuring movement as a proxy for 
waking activity. During baseline period, all supervisors and their employees in both intervention 
and control groups will be asked to wear the actigraphy devices continuously for 3 weeks, with 
instructions for care by research staff, but only those in the intervention group will receive 
individual-level feedback during the intervention stage. Those in the control group will not 
receive feedback at this time. 
 
Approximately 1 month post-baseline (during intervention stage), data from the actigraphy 
bands will be downloaded, processed by our research staff and individual, in-person feedback 
will be given to participants in the intervention group (see Appendix A for sample feedback 
report). The feedback is designed to highlight (1) sleep data from the previous 3 weeks 
highlighting daily activity and sleep/wake scoring; (2) summary sleep data comparisons with 
data from the general population, including average time of sleep onset, sleep duration, time of 
onset variability, and longest sleep period (scores differing from the norm were indicated with an 
asterisk); (3) cognitive effectiveness estimates charted from the 3 weeks derived from the sleep 
data and using a color-coded system of green, amber, and red; and (4) recommended actions 
for improving sleep.  
 
We will use online, electronic surveys (i.e., RedCap) for all employees, supervisors, and 
spouses/partners at baseline and at 4-months and about 9-months post-baseline, following 
supervisor FSSB/Sleep Leadership training and in-person sleep/cognitive effectiveness 
feedback for the treatment group. We will also conduct a COVID-related survey in November 
2020 to assess the effects of the pandemic. Surveys will be completed OFF of work time. In 
addition, we will collect objective sleep data with actigraphy devices at baseline and 9-month 
post-baseline as an objective health indicator from employees and their supervisors. We will be 
using the same actigraphy devices, and all participants will be wearing the watches for 3 weeks 
at baseline and 9-month post-baseline. Supervisors in the treatment condition will also be briefly 
surveyed at the time of training using a survey program within the computer-based training 
module. All supervisors – regardless of study conditions – will be invited to participate in the 
baseline & follow-up surveys assessing their knowledge of FSSB and sleep leadership concepts 
& assessing outcomes related to our hypotheses. All spouses/partners who live with the 
employees will also be invited to participate in the survey study at baseline, 4- and 9-month 
post-baseline. Spouse/partners will not participate in any of the actigraphy data collection.  
 
Upon completion of data collection, we will use the actigraph data collected from baseline and 
9-month post-baseline to generate feedback reports (e.g., comparison estimates) for all 
participants in both intervention and control groups. These reports will only be used for feedback 
purposes, they are not part of the intervention. The actigraph data collected from baseline and 
9-month post-baseline will also be used for our internal data analyses (e.g., combined with 
survey responses for statistical analyses and hypothesis testing). Note that the current study is 
simply using the actigraphy devices to collect data related to participants’ sleep and their daily 
activities. We are not testing the efficacy of the devices. 
 
(7) Data and Specimens 
Handling of Data and Specimens 
Confidentiality of participants’ responses will be maintained. Results will only be reported in 
aggregate form. Data from the online surveys and actigraphic assessments will be kept on our 
secure server at OHSU and only designated persons from our research team will have access. 
The REDCap program monitored by the Oregon Clinical & Translational Research Institute 
(OCTRI) at OHSU will be used for all survey data collection. It is designed to handle data 
collected from human subjects, while systematically accounting for related confidentiality issues. 

14 
 
It is also HIPAA compliant. Further, the data are protected behind a firewall and is accessible 
only by authorized research staff with a login and password combination, thus ensuring the 
confidentiality of all survey responses, email addresses, and personal information. 
 
Steps to be taken to protect the safety and confidentiality of all participants include the use of 
study code numbers for identification, data linkage of employee surveys, spouse/partner, and 
supervisor data. Participant unique identification numbers will be used to match survey 
responses between employees, their supervisors, and their spouses/partners. After merging the 
responses, the final datasets used for data analysis will be completely de-identified. Additional 
steps taken will include, reporting of aggregate data, and destroying all identifiers within three 
years after completion of the study. Participant code number lists and participant contact 
information will be kept in separate locked file cabinets. We plan to store the de-identified data 
(data from the online surveys and actigraphic assessments) indefinitely after the end of the 
study on our secure server at OHSU and on Box; only designated persons from our research 
team will have access. 
 
Researchers collecting data for the proposed study will follow all guidelines and protocols as 
authorized by the OHSU Research Integrity Department/Institutional Review Board. Personally 
identifying information such as name and phone number will be used strictly for recruitment, and 
scheduling. All contact information will be securely stored in a separate locked file cabinet in a 
locked office by research staff and will be destroyed within three years of study completion. 
 
Sharing of Results with Subjects 
Individual-level sleep/cognitive effectiveness feedback will be distributed in person to those in 
the intervention group as part of the intervention design. Individualized reports containing 
actigraphic measurements and summary estimates relevant to participants’ own sleep habits, 
sleep quality, sleep quantity, etc. will be shared with participants during the sleep/cognitive 
effectiveness feedback intervention period (around 1-month post baseline; during intervention 
phase). Aggregated results without any identifying information will also be shared via email to all 
participants. Their email addresses and other identifying information will be kept separate from 
the individual-level data.   
 
Upon completion of data collection, we will use the actigraph data collected from baseline and 
9-month post-baseline to generate feedback reports (e.g., comparison estimates) for all 
participants in both intervention and control groups. These reports will only be used for feedback 
purposes, they are not part of the intervention.  
 
(8) Data Analysis 
Descriptive and Psychometric Analyses: 
As we are exclusively using established and validated measurement instruments, we do not 
anticipate psychometric problems. However, we will perform the standard set of psychometric 
analyses on each of these measurement instruments to verify their performance with the current 
sample. Analyses will include descriptive item and scale statistics and verification of scale 
reliabilities and factor structures. Assessment of scale reliabilities (e.g., Cronbach’s alpha) and 
factor structures will use established confirmatory factor analysis methods. In the event that we 
find poorly performing measurement instruments, we will explore whether better psychometric 
performance can be obtained by deleting some of the scale items, as long as doing so is 
theoretically defensible. 
 
Power Analysis:  

15 
 
This section documents the power analyses we conducted for the planned analyses for 
hypothesis testing. We focus on power for the analyses involving employee-level outcomes. To 
estimate power for Service member-level outcomes, we based our effect size estimate for the 
intervention’s effect on physical health from the data reported in Hammer et al. (2011), i.e., d = 
.33 (ICC = .03) after controlling for baseline physical health and a workplace intervention’s effect 
on sleep problems (d = .30; ICC = .01) from (Adler, Gunia, Bliese, Kim & LoPresti, working 
paper). We assumed 24 randomized clusters. Throughout, we set alpha = .05 to define 
statistical significance. Power analyses for the employee-level outcomes were conducted using 
Optimal Design (Version 2.01) software package (Raudenbush, Spybrook, Congdon, Liu, and 
Martinez, 2011). With these assumptions, the estimated power for the effect of the intervention 
on physical health would be .95 and on sleep problems would be .83 with 500 enrolled 
employees at baseline. Assuming an attrition rate of 20% (see Missing Data discussion below) 
resulting in a total sample size of 400 employees across the 24 randomized clusters, the 
estimated power for the effect of the intervention on physical health would be .86 and on sleep 
quality would be .80. Thus, we have demonstrated adequate power to test our hypotheses for 
employees. 
 
Missing Data and the Application of Intent-to-Treat: 
Missing data intermittently during the study and/or dropouts are inevitable and an issue faced by 
all longitudinal studies. There is no consensus, however, on the optimal analytical strategy to 
analyze missing data. Using the standard missing data taxonomy (Rubin, 1987), we will follow 
the recommendations made by Nich and Carroll (1997, 2002) and conduct intent-to-treat 
analyses using three strategies. In the first strategy we will extend the multiple imputation 
method of Little and Yau (1996) to allow for non-monotone missing values, which could occur 
intermittently during the study period. Monotone missing patterns require subsequent variables 
to be missing once a variable is missing. We will impute unobserved outcomes based on study 
condition, observed subject-level covariates at baseline and observed follow-ups. Inferences will 
be made on imputed datasets using Rubin’s method (Barnes, Lindborg, & Seaman, 2006; 
Rubin, 1996). Our second analytical strategy will consider selection models and pattern-mixture 
models (Michiels, Molenberghs, Bijnens, Vangeneugden, & Thijs, 2002) based on different 
factorization of the joint distribution of the response variables and the missing patterns. As 
different strategies require different assumptions for the estimated treatment effects to be 
unbiased and some assumptions are not testable, comparisons of these strategies serve mainly 
as sensitivity analyses of their influence on the estimated key parameters of each Aim. A third 
strategy will consider the use of Full Information Maximum Likelihood methods in the analysis of 
incomplete data as implemented in several software programs (e.g., Mplus; Muthen & Muthen, 
2007). As mentioned in the prior section, this study is adequately powered for an attrition rate of 
20%. 
 
Analysis of Research Questions/Hypotheses: 
The data for this study are generated from a cluster randomized experimental design with all 
participating supervisors and their employees within a facility cluster randomly assigned to 
either an intervention or usual practice control condition. Standard general linear and 
generalized linear mixed model approaches for cluster randomized designs (i.e., hierarchical 
linear models, multilevel models; Murray, 1998; Murray, Varnell, and Blitstein, 2004) will be 
used for data analysis for our research questions/hypotheses to account for the nesting 
structure in the data. As these models are now widely used and understood and are available in 
numerous statistical software packages, our discussion here on the specifics of these analyses 
will be brief. In each case, link functions for these models will be determined by the scaling of 
each outcome variable. Furthermore, in each analysis we will use the outcome variable at 
baseline as a predictor in the model to adjust for unexpected imbalance from randomization and 

16 
 
to increase the statistical power for and precision of parameter estimates. Cluster differences 
will be modeled as random effects. Finally, the recruitment wave (i.e., block), rank, gender, unit 
type, marital status, and mental health symptoms will be used as predictors in the statistical 
models. Of interest in these models is the direction, magnitude, and statistical significance of the 
parameter corresponding to the indicator of intervention group, which appears at the 
organization level of the multilevel analysis. For example, Physical Health scores at 4-months 
will be regressed on an indicator of intervention condition and Physical Health scores at the pre-
intervention assessment, minimally specifying a random effect for the intercepts across 
organizations. As needed, depending on attrition and missing data, this basic generalized linear 
mixed model will be extended in the analysis of the specific aims as mentioned in a prior section 
(e.g., multiple imputation for missing predictor variable values, FIML estimation for missing 
outcome variable values). 
 
(9) Privacy, Confidentiality and Data Security 
Confidentiality of participants’ responses will be maintained. Results will only be 
reported/published in aggregate form. Data from the online surveys and actigraphic 
assessments will be kept on our secure server at OHSU and on Box; only designated persons 
from our research team will have access. REDCap is designed to handle data collected from 
human subjects, while systematically accounting for related confidentiality issues. The data are 
protected behind a firewall and is accessible only by authorized research staff with a login and 
password combination. REDCap also meets the privacy standards set forth by the Health 
Insurance Portability and Accountability Act (HIPAA), ensuring the confidentiality of all survey 
responses, email addresses, and personal information. 
 
Steps to be taken to protect the safety and confidentiality of all participants include the use of 
study code numbers for identification, data linkage of employee surveys, spouse/partner, and 
supervisor data. Only OHSU personnel in this project, specifically Krista Brockwood, Phoenix 
Rainbird and Jason Malach-Fuller, will have access to the code key. Additional steps taken will 
include, reporting of aggregate data, and destroying all identifiers within three years after 
completion of the study. Participant code number lists and participant contact information will be 
kept in separate locked file cabinets. 
 
Researchers collecting data for the proposed study will follow all guidelines and protocols as 
authorized by the OHSU Research Integrity Department/Institutional Review Board. Personally 
identifying information such as name and phone number will be used strictly for recruitment, and 
scheduling. All contact information will be securely stored in a separate locked file cabinet in a 
locked office by research staff and will be destroyed within three years of study completion. 
 
(10) Risks and Benefits 
Risks to Subjects 
Efforts will be made to minimize risks associated with this study. Minimal potential risks for 
participation include breaches of confidentiality associated with data collected for research 
purposes and minimal psychological distress associated with the psychological distress survey 
measures and sleep feedback. Additional potential, but not expected, risk is that a supervisor 
may be upset about being contacted to participate in a study or may not like the supervisor 
training. Supervisors can discuss these issues at any time with research staff. 
 
Risk management and emergency response:  
To mitigate potential distress related to the psychological well-being survey items, participants 
will be made aware that participation is completely voluntary and that they are welcome to 
withdraw involvement at any moment without consequence. The data is protected behind a 

17 
 
firewall and is accessible only by authorized research staff with a login and password 
combination. Further, surveys are securely protected under the REDCap survey program, which 
meets the privacy standards set forth by the Health Insurance Portability and Accountability Act 
(HIPAA), ensuring the confidentiality of all survey responses, email addresses, and personal 
information. Additionally, a list of resources to assist with psychological and physical distress, 
family resources, at both the state and national level will be provided on our study website. 
 
Potential Benefits to Subjects 
We expect positive results for all study participants, including reduced stress and increased 
social support. Employees of these supervisors are also expected to benefit from this training 
because the supervisors are expected to be more supportive of their employees. Longer term, 
these effects are expected to create a more supportive work environment for study participants, 
which has positive effects on safety, health, well-being, family, and organizational outcomes 
among participating employees, supervisors, and spouses/partners. We also expect that 
providing study participants (from both intervention & control groups) with 
individual/personalized sleep feedback will reduce sleep problems and improve sleep 
awareness.