Healing Lodge First Face Training Evaluation Study
Phase: NA
Conditions: Addiction, Depression/Anxiety, Trauma, Psychological, Self-harm
Sponsor: Cambridge Health Alliance

Protocol Version Date/Number: March 17, 2025, version 5.0 (Modiﬁcation 004) 
 
I. Background & Rationale 
With funding from the National Institutes for Health, we created First Face for Mental 
Health. First Face is a culturally-appropriate community-based mental health training that 
prepares trainees to provide assistance to someone having a mental health crisis. The 
more community members within Tribal nations who are trained in a culturally sensitive 
program to provide support to youth in recovery and members struggling with mental 
health problems or crises, the better positioned that community is to create a supportive 
recovery environment for its youth. We are in the process of launching First Face trainings 
and evaluations among several Tribal communities. Additionally, we will be training staff 
from the Healing Lodge of the Seven Nations (HL) in the First Face program. This particular 
application concerns the evaluation of First Face training among HL staff.  
 
II. Aims & Hypotheses 
Our goal is to evaluate the impact of First Face training on the trainees. We hypothesize 
that trainees will demonstrate: (1) gains in their knowledge of mental health/addiction 
issues, (2) gains in their conﬁdence in providing ﬁrst aid to people experiencing mental 
health/addiction crises, and (3) decreases in stigma toward people experiencing mental 
health/addiction issues, from pre-training to post-training and will retain these 
improvements until a 3-month follow-up. This evaluation will provide evidence about the 
effectiveness of the First Face training program among workers in a healthcare setting and 
guide future modiﬁcations and expansions of the curriculum. 
 
III.  Research Plan 
A. Study Design 
This study will use a longitudinal research design to assess the direct effects of the First 
Face training. 
 
B. Study Location 

This study will take place at the Healing Lodge of the Seven Nations (HL), a residential 
treatment facility located in Spokane, WA. Only HL staff will participate in the evaluation; 
no residents will be involved. 
  
C. Funding 
This study is part of the Capacity Building Core component of “Assessing Cultures of 
Recovery in Tribal Communities,” a Native American Research Centers for Health (NARCH) 
Center grant awarded to us through the National Institutes of Health (#S06GM146095). As 
the funder, NIH does not provide IRB oversight but will require us to submit our letter of 
approval once the IRB protocol is approved by the PA-IRB. 
  
D. Collaboration 
This study is a collaboration between researchers at the Healing Lodge of the Seven 
Nations and Cambridge Health Alliance. Because all activities will take place at the Healing 
Lodge, we are requesting that the Portland Area IRB serve as the reviewing IRB for this 
study. We will ask the Cambridge Health Alliance IRB to cede review to the Portland Area 
IRB. 
  
E. Subject Populations 
This study will involve HL staff members.  
 
F. Recruitment  
We will work closely with HL leadership to determine the timing of each First Face training 
session, minimizing any disruptions to the delivery of services. Training will take place in 
small groups at the Healing Lodge, led by the HL’s ﬁve Training & Research Coordinators 
(TRCs; Ms. Barlow, Ms. Jones, Ms. Bird, Ms. Campbell, and Ms. Bliesner).  All TRCs have 
been trained in human subjects research/good clinical practice. They are supervised at the 
HL by Dr. Bowman and Dr. Zuckerman. We anticipate that HL leadership will make First 
Face training mandatory for all staff; however, participating in the evaluation will be 
optional. During 2024, the TRCs will train current HL staff.  
 

There will be a $20 gift card for completing the 3-month follow-up assessment. The TRC 
names listed above are current as of this modiﬁcation.  
 
G. Informed Consent 
The informed consent document will inform potential participants about the nature of the 
study, including all potential risks and procedures for minimizing those risks.  The TRCs will 
explain the nature and purpose of the evaluation, including its voluntary nature. They will 
be available in-person to answer any questions about it.  
 
H. Study Procedures and Materials 
We have designed our study procedures to minimize the potential for perceived 
coercion/undue inﬂuence and the risks associated with a breach of conﬁdentiality.  
 
When they enter the training room, participants will be given a letter-sized mailing envelope 
that includes an informed consent form and the pre-training and post-training surveys. 
After participants settle in, the TRCs will explain the nature and purpose of the evaluation, 
including all major points included in the informed consent form. Before the training 
begins, participants will be given ample time and space to read/sign the informed consent 
statement and complete the pre-training survey. The consent statement will ask for 
participants’ email addresses, for the purposes of contacting them later. The TRCs will tell 
them that they are free to leave the documents blank, without consequence. The TRCs will 
remain at a respectful distance during this time so as to minimize any appearance of 
coercion. Participants will be instructed to return the consent form and pre-training survey 
(completed or blank) into the envelopes. After the training is complete, the TRCs will use 
the same process to administer the post-training survey. Then they will collect the 
envelopes and bring them to their private office space at the HL and store them in locked 
ﬁle cabinets.  There are no alternative procedures.  
 
Three months after the staff training is complete, a TRC will email all participants a link to 
an electronic survey which includes the 3-month follow-up questions. The email will be 
sent to the HL addresses collected on the consent forms but will use blind carbon copy. 
The follow-up survey will be hosted on a web-based survey platform attached to the co-PI’s 

Cambridge Health Alliance account. The survey will ask for participants’ names, for the 
purpose of connecting 3-month follow-up surveys with pre- and post-training surveys.  
 
Dr. Gray will download the 3-month follow-up survey dataset from Qualtrics. She will 
upload it to the Division on Addiction’s HIPAA-compliant Google business drive and 
permanently delete the locally saved/downloaded ﬁle. Working within the Google drive 
version, a TRC will add new columns for participants’ pre-and post-training survey data. 
Using participants’ names as a linking identiﬁer, the TRCs will enter in all pre- and post-
survey data. When all data entry is complete, the TRCs will delete the participant name 
column from the dataset. Then, the TRCs will separate consent forms from completed pre-
training/post-training surveys, leaving no way to re-connect identiﬁers to survey data. The 
TRCs will store these forms in a locked ﬁle cabinet in their HL office space.  
 
We will provide an additional option for participants who would prefer to complete their 3-
month follow-up survey using a hard copy, rather than online. Paper copies of the survey 
will be available in 3 locations on the Healing Lodge campus: (1) in the main administration 
building, in care of the receptionist; (2) in the HOPE building, in the care of the TRCs; and in 
the PSSD building, in care of Dr. Zuckerman. Once per month during active data collection, 
the Healing Lodge Executive Director will send an email blast to all employees informing 
them that the survey is available in these locations and encouraging them to complete it. 
The email will be general, rather than speciﬁc to only participants who have not yet 
completed their survey, because the Executive Director will have no access to individual-
level data including whether participants have completed their follow-up survey. 
Participants who elect to complete a hard copy will get a blank copy from the designated 
records custodian at each location (i.e., the receptionist, the TRCs, Dr. Zuckerman), along 
with a sealable letter-sized manila envelope and, if necessary, a clipboard and pen. They 
will complete the survey, seal it in the envelope, and return it to the records custodian for 
safe storage until a TRC or Dr. Zuckerman can pick it up. TRCs or Dr. Zuckerman will go to 
these locations each day to pick up completed surveys. They will bring completed surveys 
to their dedicated office space in the HOPE building, where they will store and enter the 
data as they do for hard-copy surveys administered on the day of the First Face training.  
 
In the text of the email inviting participants to complete their  3-month follow-up survey, 
and at the end of the survey itself, we will direct participants who complete their 3-month 
follow-up survey to go to the HOPE building and speak with one of the 6 TRCs to receive 

their $20 gift card incentive. We will retroactively provide a $20 gift card to participants who 
completed their 3-month follow-up survey in the summer of 2024.  
 
In the text of the email inviting participants to complete their  3-month follow-up survey, 
and at the end of the survey itself, we will direct participants who complete their 3-month 
follow-up survey to go to the HOPE building and speak with one of the 6 TRCs to receive 
their $20 gift card incentive. We will retroactively provide a $20 gift card to participants who 
completed their 3-month follow-up survey in the summer of 2024.  
We will also prepare a ﬂyer with a QR code that directs participants to the 3-month follow-
up survey hosted on the Qualtrics survey platform. We will post this ﬂyer in common areas 
and leave it in participants’ Healing Lodge mailboxes.  
To provide another opportunity for participants to complete their 3-month follow-up survey, 
the TRCs will host 3-5 group survey sessions. They will select an appropriate location on 
the Healing Lodge campus and invite participants to come and complete their 3-month 
follow-up survey. They will select times in consultation with department managers/human 
resources. The TRCs will ensure that at these group survey sessions, participants will have 
ample space and privacy to complete the survey. TRCs will provide gift cards immediately 
after participants complete and return the survey. TRCs will store completed surveys in 
locked cabinets in the Hope Building. They will promote these survey sessions via email. 
Additionally, the survey sessions will be promoted by (1) the Healing Lodge Executive 
Director via an all-hands email, (2) department managers during department meetings, and 
(3) and on informational screens that appear around campus. This will ensure that 
participants know they can take the time to complete their surveys during work hours 
without experiencing any punishment. The promotions will include a reminder that 
completing the survey is voluntary. 
We will assess changes in three domains: 
1. Knowledge of mental health/addiction issues, including knowledge of the 5 “Healing 
Hands” steps, which are a foundation of First Face training 
2. Conﬁdence in providing ﬁrst aid to people experiencing mental health/addiction 
crises 
3. Stigma toward people experiencing mental health/addiction issues 
 

Additionally, the post-training survey will assess satisfaction with the training and 
intentions to use the training. The 3-month follow-up survey will assess use of the training. 
 
To explore potential moderators of effectiveness, we will assess participant characteristics 
(e.g., department, years working with at-risk youth, past mental health/addiction training). 
For instance, more experienced staff members might show smaller improvements in study 
outcomes because they have less room for growth before they complete the training.  
 
I. Risk/Beneﬁt Assessment 
Risks. Participating in this evaluation presents psychological/social risks but no legal, 
ﬁnancial, or physical risks. Some participants might experience discomfort or distress from 
answering questions. Accidental disclosure of study data presents another risk to 
participants.  
 
Protection Against Risks. The consent form will assure participants that they are not 
required to engage in the evaluation or answer any questions that make them 
uncomfortable. Our procedures for data collection, transfer, and storage will ensure that 
there will be no security breaches. Hard copies of consent forms and pre- and post-training 
surveys will be stored in locked ﬁle cabinets in the Hope Building on the HL campus. Only 
members of the study team located at the Healing Lodge will have access to them. 
Subsequently the TRCs will enter data into an electronic database. Division on Addiction 
staff members named in this protocol will assist the TRCs with data analysis, 
interpretation, and dissemination. Therefore, the electronic database will be stored on the 
Division on Addiction’s password-protected shared Google Drive, which is part of the 
Cambridge Health Alliance HIPAA-compliant Google business account. No publications or 
presentations will include potentially identifying information.  In keeping with open science 
best practices, we might, with permission from the Healing Lodge Board of Directors, make 
the raw data publicly available. However, we will minimize the number of potentially 
identifying characteristics included in the dataset to prevent deductive disclosure. The 
consent form will also include a Certiﬁcate of Conﬁdentiality section. 
 
Potential Beneﬁts of the Research to Participants and Others. This evaluation holds the 
potential to advance an intervention designed by and for Tribal communities to help their 
youth struggling with addiction or mental health issues. The evaluation, if positive, will 

provide evidence supporting First Face’s effectiveness and encourage widespread 
adoption. If First Face does not demonstrate effectiveness, the study will provide 
information about how to improve it.  
 
Vulnerable Participants: Children. No children will be recruited into this study. 
Employees. We acknowledge that the participation of Healing Lodge employees might 
present special concerns, particularly the potential for perceived coercion. We will take 
several steps to minimize perceived coercion. The consent form will assure potential 
participants that they are not required to engage in the evaluation or answer any questions 
that make them uncomfortable. The TRCs will give potential participants personal space to 
complete, or elect not to complete, the consent form and surveys. Because all potential 
participants will place their consent forms and surveys back into the provided envelope, 
regardless of whether the forms have been completed, it will not be obvious whether 
employees have elected to participate in the evaluation. Finally, potential participants will 
be informed that only the research team will have access to collected data.  
 
J. Data and Safety Monitoring Plan 
We consider this research to be minimal risk, with the primary risks being the potential for 
some emotional distress based on the training or surveys, and potential breach of 
conﬁdentiality. In addition to the steps taken to protect against these risks detailed above, 
we will follow the guidelines set out below. 
 
We have already obtained Resolutions supporting this work from the Healing Lodge Board 
of Directors and all seven Tribes that support the Healing Lodge. In addition, the Division on 
Addition will be signing a Data Sharing Agreement with the HL. We will submit that 
agreement to the IRB as soon as it is signed. We will also submit all manuscripts to the 
Healing Lodge Board and the IRB to obtain approval prior to submission for publication. 
 
We will protect participants’ conﬁdentiality by storing data securely, as described earlier in 
this protocol. The research team will meet weekly to review the project and data collection 
efforts. We have had success with this model, using technology to meet remotely across 
sites on a weekly basis for our previous NARCH VIII and NARCH X projects. 
 

During data collection periods, the research team will meet weekly. During these meetings, 
the TRCs will have the opportunity to raise any concerns about participants’ experiences in 
the study concerns or protocol compliance with Dr. Gray. In addition, the phone number 
provided for study participants to contact with concerns or questions will be monitored on 
a daily basis. Dr. Gray will be responsible for reporting any adverse events in a timely 
manner to the IRB in accordance with IRB rules and regulations. In addition, Dr. Gray will 
review any unexpected ﬁndings, unanticipated ﬁndings, or issues regularly with the 
research team so that corrective actions, if necessary, can be taken promptly. We do not 
anticipate that any aspect of this study will affect the safety of participants. However, if our 
review detects any ﬁndings or patterns that call into question the safety of the First Face 
Healing Lodge training evaluation, we will stop the study until these issues are resolved.