Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project
Phase: NA
Conditions: Chronic Disease
Sponsor: Montana State University

Clinicaltrials.gov: Cover page 
Official title of study: 
Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah 
Project 
NCT number: NCT03036189 
Date of the document: 10/2019
(note: this is a compilation of documents dating from 7/2017-10/2019) 

MONTANA STATE UNIVERSITY 
Institutional Review Board Application for Review 
(revised 06/01 /15) 
*********************************************************************************************************************** 
THIS AREA IS FOR INSTITUTIONAL REVIEW BOARD USE ONLY. DO NOT WRITE IN THIS AREA 
Application Number: 
Approval Date: 
Disapproved: 
IRB Chair's Signature: 
********************************************************************************************************************** 
Date: July 13, 2017 
I. Investigators and Associates (list all investigators involved; application will be filed under name of first 
person listed) 
NAME: Suzanne Held 
DEPT: 
Health and Human Development 
COMPLETE ADDRESS: 318 Herrick Hall 
TITLE: Professor 
PHONE#: 406-994-6321 
E-MAIL ADDRESS: 
suzanne@montana.edu 
DATE TRAINING COMPLETED: 1/20~~"i [Required trainingj C•/TI .Training; see website for link] 
SIGNATURE (Pl or ADVISOR): ,zJl J?Lt'/lt( iLli'l 
-
i :, 
NAME: Alma McCormick 
TITLE: Executive Director 
DEPT: Messengers for Health 
PHONE#: 406-665-5492 
COMPLETE ADDRESS: PO Box 940, Crow Agency, MT 59022 
E-MAIL ADDRESS: alma.mccormick@montana.edu 
DATE TRAINING COMPLETED: 2/2016. [Required training: CIT/ Training; see website for link] 
NAME: Mark Schure 
DEPT: 
Health and Human Development 
COMPLETE ADDRESS: 305 Herrick Hall 
TITLE: Assistant Professor 
PHONE#: 406-994-3248 
E-MAIL ADDRESS: 
mark.schure.montana.edu 
DATE TRAINING COMPLETED: 10/2015. [Required training: CIT/ Training; see website for link] 
NAME: Jim Becker 
TITLE: Assistant Professor 
DEPT: 
Health and Human Development 
PHONE#: 406-994-6854 
COMPLETE ADDRESS: 103A Romney Gym 
E-MAIL ADDRESS: 
james.becker4@montana.edu 
DATE TRAINING COMPLETED: 10/2016. [Required training: CIT/ Training; see website for link] 
you answered 
you will 
lo contac! 
D 
D 

II. 
Title of Proposal: The Baa nnilah Project 
Ill. Beginning Date for Use of Human Subjects: 8/1/2017 
IV. Type of Grant and/or Project (if applicable) 
Research Grant: xx 
Contract: 
Training Grant: 
Classroom Experiments/Projects: 
Thesis Project: 
Other (Specify): 
V. 
Name of Funding Agency to which Proposal is Being Submitted: funded from the National Institutes of 
Health, U01MD010619, Co-Pis: Suzanne Held & Alma McCormick 
VI. Signatures 
Submitted by Investigator 
Typed Name: Suzanne Held 
Signature: 
v/JJy .. 'L·' ,.,r. 
Date: 7/13/2017 I"'""' V·'' ·" + 
.. 
VII. Summary of Activity. Provide answers to each section and add space as needed. Do not refer to an 
accompanying grant or contract proposal. 
A. RATIONALE AND PURPOSE OF RESEARCH. (What question is being asked?) 
Urgent attention is needed to address the significant disparities between whites and American Indians (Als) in 
age at death for those with chronic illness (Cl). In our state of Montana, Als die 14 years earlier for those with 
heart or kidney disease, 12.5 years for those with diabetes, and 11 years for those with cerebrovascular 
disease(1 ). Existing programs addressing Cl management, which can lead to lower mortality rates and a 
higher quality of life, fail because they are not consonant with the Al culture. To address this failing, we 
developed Baa nnilah, an innovative and unique program to improve capabilities for Cl management among 
Apsaalooke (Crowl Indians in Montana. 
The study is based on methods and findings from a 19-year community-based participatory research (CBPR) 
partnership between members of the Apsaalooke Nation and faculty and students at Montana State University. 
Community members asked the partnership to develop an effective intervention for Cl management. The 
development, implementation, and evaluation of a culturally centered intervention for improving Cl 
management can serve as an important model for other communities and tribal nations looking to improve Cl 
health disparities and has implications for management of acute conditions. 
Using a CBPR approach, we completed qualitative interviews with 20 Al men and women on the Apsaalooke 
Reservation who had a Cl diagnosis. After we developed a culturally consonant method for co-analyzing the 
data with our community advisory board (CAB), we analyzed the data and used the findings to develop a 
conceptual framework and intervention for understanding and improving Cl management, something that had 
not existed for this population. Our intervention will be tested across multiple Cls, as our analysis findings 
matched other Cl management interventions in that "people with chronic conditions have similar concerns and 
problems"(2-4). The intervention is titled Baa nnilah, which translates to advice or instructions for life that are 
received from others, often in a story form. The method for Baa nnilah is centered on Apsaalooke cultural 
strengths. The content of Baa nnilah is based on our conceptual framework of influencers of Cl management 
gleaned from the interview data. The measured outcomes flow directly from the conceptual framework and 
intervention content. Baa nnilah is a group intervention comprised of 1 O groups of 11 tribal members: a trained 
facilitator, who is considf;lred a successful manager of his/her Cl, and 10 mentees, who are not managing their 
illness well. Each 11-member group will meet 7 times covering content and using methods outlined in our 
intervention manual that include a mini-discussion (lecture), talking circle and skill-building activity. The 
mentees will be partnered into supportive pairs who will connect a minimum of once per week outside of group 
meetings. Topics include those found in both our interview data and existing evidence-based self-management 
programs (e.g., developing a positive relationship with a healthcare provider) and Apsaalooke-specific topics 

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from our interview data (e.g., coping with historical and current grief and loss). Consistent with the stages of 
behavioral therapy research(5) and using a CBPR approach, we will pursue the following Specific Aims: 
Aim 1: Refine and strengthen the community-based, culturally appropriate Baa nni/ah intervention and 
study protocol. 
Involved will be the CAB, the Apsaalooke-based and MSU-based research team, and four potential 
Aakbaabaaniilea (facilitators). This aim will be accomplished in Year 1 and will result in a finalized training and 
intervention manual that will be utilized to train Aakbaabaaniilea and deliver the intervention. 
Aim 2: Test the effects of the Baa nnilah intervention versus usual care using a wait-list control group 
effectiveness trial among 200 randomly assigned Al men and women 25 and older who have Cl on the 
Apsaalooke Reservation. 
Primary hypothesis: Those Al adults on the Apsaalooke Reservation participating in the Baa nni/ah 
intervention will have significant improvement in quality of life using the SF-12 measure compared to a wait-
listed control group immediately following the intervention and at 6 and 12 months post-intervention. 
Secondary hypothesis: Those Al adults on the Apsaalooke Reservation participating in the Baa nnilah 
intervention will have significant improvement in measures of satisfaction in and participation with social roles 
and activities, social isolation, patient activation, health care relationship, physical function. and depression 
compared to a wait-listed control group immediately following the intervention and at 6 and 12-months post-
intervention. Our mixed-methods design includes a qualitative evaluation of fidelity and acceptability 
immediately post-intervention. 
This study is considered a Phase 3 clinical trial. Please see the attached document, "Protection of Human 
Subjects" from our grant application that contains human subjects information (some overlap with what is 
below) and our Data Safety and Monitoring Plan, which is required for Phase 3 clinical trials. This clinical trial 
has been registered at Clinicaltrials.gov with the following NCT identifier: NCT03036189. 
As this project takes place on a reservation, please see the attached letter of support/approval from the Crow 
Nation. 
See picture below for a graphic depiction of our study design: 

Research Design of the Bili nalltt/1 Program 
A Group Randomized Trial 
Mentors (Na 10) recruit eligible par!ielpanls (20 participants per mentor), obtain informed 
comoenl, & identify familyJfrlends clustllrs. A unique ID is assigned to eacil mentor, each 
family/friends cluster; and each participant, respecllvely, By August 15, 2011 
I 
Familylfrieoo" clusters ara rand<>mly assigned, matching on menlor and gmup size {i,,e,, family/friemls clusters are 
sorted by size per mentor, and !he two larges! fam!lylfrl•end clusters per me11oor are randomly assigned to Ille 
lnl<!rve11!ion and Control groups, the11, the next two !arg·es! clusters per m1ml<>r are randomly assigned, etc,). 
I 
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Basei'ine measuras are obtained from all participants: Oclober .H17 J 
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Nov 2017· ~ 
Waltllllt Control Group" 
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Feb 2018 
~ceive 
Usual Care for 4 monl~ 
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Outc<>m<> m"""ures are obtaim;d from all participants ol lnlerventlon and Waitlisl Control Groups: March 2018 
(__-- lnle!Vention Groups Receive 
'---
Usual Care for 4 months 
-
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--~ April-July 
_./ 2018 
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Waitlist Control Groups Receiv" ihe -) 
----
~Ml1!lllP'"ll""m for 4 months 
----
Outcome measures are obtained from all partil::ipanls of lnterv.,nli<>I! and Waillls! Co11lrol Groups: August 2018 
Outcome measures are obtained Imm all parliclpan!s of Intervention (Optional) and Waitlist Control Groups: 
December 2018 
B. 
RESEARCH PROCEDURES INVOLVED. Provide a short description of sequence and methods of 
procedures that will be performed with human subjects. Include details of painful or uncomfortable procedures, 
frequency of procedures, time involved, names of psychological tests, questionnaires, restrictions on usual life 
patterns, and follow up procedures 
There are three different groups from whom data will be gathered. Answers to the questions below are 
grouped according to who is providing the information. 
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
1. Participants of intervention: all participants: 200 Crow community members will be recruited by other 
community members (described below under D5), provide informed consent (form attached), and be 
randomly assigned by family/friend cluster to an intervention or wait-list control group (both groups will 
receive the intervention). Random assignment will occur via cluster so that family members or friends 
who are interested in participating in the intervention together will remain in the same group. During 
the month of October 2017, groups of approximately 1 O community members will attend an orientation 
and data collection session - this is the baseline data collection. The groups are based on the 
community in which they will attend the intervention meetings and include: Wyola, Lodge Grass, Crow 
Agency, Hardin, and Pryor, MT. 
During the orientation/data collection session, participants will complete a survey and 3 exercises. All 
measures in the survey that are in an index form (one measure with multiple questions) come 
from the NIH PROMIS measure bank (http://www.heallhmeasures.net/index.php), are other 
validated measures, or are demographic or fidelity measures used in other studies. All measures 

are included with the application and begin with the page labeled "Measures". The survey 
responses and results of the exercises will be on a tablet computer and will look similar on the 
computers (the measures attached are in different formats at present). 
The survey questions will be read out loud by a project staff member. Participants will be seated so that 
they do not see the responses being entered into other computer tablets by other participants. We 
are working with the MSU HELPS lab to facilitate data collection. Survey respondents will provide 
their responses on tablet computers using Qualtrics offline software and unique identification 
codes. Once a respondent has submitted the survey, those answers will not be viewable by 
subsequent research participants. The responses will upload to the secure Qualtrics servers once 
the tablets are again connected to a wi-fi network. Data will not be maintained on the tablet 
computers in the long term. 
Three basic physical function tests will be performed: timed up and go (TUG), static balance assessment 
(BESS), and 6 minute walk. Brief descriptions of the tests are below. Responses will be entered 
into the computer tablets. 
Timed Up and Go (TUG) Test: This test is commonly used in clinical settings to assess strength, mobility, and 
balance control in older adult populations. The test starts with the participant sitting in a chair. 
Examiner ensures that they are sitting all the way in the chair, i.e with their hips at the back of the seat 
and their back resting against the chair upright. When the examiner says go, the participant rises from 
the chair, walks forward to a tape placed on the ground, turns around, walks back to the chair, and sits 
down. The tape is placed 3 meters in front of the chair. The participant is instructed to "rise from the 
chair, walk to the tape and back, and sit back down as quickly as possible while still walking safely." 
Including "as quickly as possible" in the instructions ensures the assessment will appropriately 
challenge the participant, while including "while still walking safely" ensures that the participant knows 
not to go so fast that they risk losing their balance or falling as they try to sit back down. The outcome 
measure recorded from this test is the time taken from first movement out of the chair until they sit 
back down. The image below shows a schematic of the test. 
3m 
Standing Balance Assessment. To assess static balance the balance error scoring system (BESS) will be 
used. This test is commonly used in clinical setting where one needs to assess an individuals' 
balance control but does not have access to force plates or pressure pads. The test includes standing 
in three different positions, on both a solid and deformable surface. The positions are: feet together on 
solid surface, on a single foot on solid surface, and in tandem stance (one foot in front of the other) on 
a solid surface. These are then repeated while standing on a foam pad. Each position is held for 20 
seconds and participants are instructed to keep their eyes closed for all tests. The test is scored 
based on the number of errors made. An error includes if the participant opens their eyes, moves their 
hands from their hips, takes a corrective step, or makes other significant postural corrections during 
the 20 seconds (i.e. flexes or abducts the hip beyond 30 degrees or raises the heel or forefoot off the 
floor). The image below shows the six different positions. 

6 Minute Walk. To assess cardiovascular fitness, participants will walk as far as possible in six minutes. 
Depending on the space available, this can be around the outside of a large room or could be back 
and forth in a hallway. A step counter is used to record the number of steps the individual takes in the 
six minutes. Distance walked can then be calculated based on the length of an individual step. 
See the research design graphic above: Next, participants in the intervention group will attend the intervention. 
The intervention consists of 7 group education sessions (called gatherings), conducted every other 
week in the local communities and led by community mentors. A manual for the mentors for the 
education sessions is being finalized at this time so that the sessions remain consistent across 
mentors and across the intervention and wait-list control groups; all mentors have been recruited and 
are meeting monthly with project staff to co-develop the intervention materials and receive training. 
Next, all 200 participants will attend another data collection session in their same groups in March 
2018. Next, the waitlist control group will attend the 7 intervention sessions, which will be identical to 
the intervention group via the mentor manual. All 200 participants will provide outcome measures 
again in August 2018 and December 2018. The measures will be the same for each data gathering 
session with the exception of a few questions that will be asked after the intervention only (as noted in 
the attached measures handout) and are focused on measuring outcomes related to intervention 
content. 
2. Participants of intervention: subgroup. A random sample of 20 participants will be selected - 10 from the 
intervention group and 10 from the wait-list control group. These participants will be invited to 
participate in a qualitative interview. Alma McCormick, Co-Pl of this grant will conduct the interviews, 
which are expected to last approximately one hour. The interview will be audio-taped and transcribed 
verbatim. Qualitative data analysis methods used in our prior studies will be conducted on this data. 
Participants will select a location to be interviewed where they are comfortable and where 
confidentiality will be assured. The questions for the qualitative interview are included with this 
application and are titled: "Baa nnilah program qualitative interview questions" 
3. Intervention facilitators: 10 members of the Crow Nation will be facilitating the intervention meetings and will 
provide fidelity evaluation information. The questions for the fidelity evaluation are included with this 
application and are titled "Facilitator measures of fidelity." Treatment fidelity refers to the 
methodological strategies used to monitor and enhance the reliability and validity of behavioral 
interventions. Facilitators will complete a form for each gathering that includes a check list of 
completed activities, 2 closed-ended questions, and 1 open-ended question. An example is included 

with the application and is titled "Mentor Gathering Check list" 
C. DECEPTION - If any deception (withholding of complete information) is required for the validity of this 
activity, explain why this is necessary and attach debriefing statement. 
1, 2, 3: No deception will be conducted. 
D. SUBJECTS 
1. Approximate number and ages 
How Many Subjects: 1: 200; 2: 20; 3: 10 
Age Range of Subjects: 1, 2, & 3: 25 and older 
How Many Normal/Control: 0 
Age Range of Normal/Control: 0 
2. Criteria for selection: 
1. Participants of intervention: all participants: criteria include 25 and older, American Indian living on or near 
the Crow reservation, and with a diagnosed chronic illness. 
2. Participants of intervention: subgroup: criterion is being a member of the intervention participant group. 
3. Intervention facilitators: criterion is being one of the 10 facilitators of the intervention 
3. Criteria for exclusion: 
1. Participants of intervention: exclusion criteria include an advanced terminal condition that precludes 
participation. 
2. Participants of intervention: subgroup: exclusion criteria include not being a member of the intervention 
participant group. 
3. Intervention facilitators: these individuals have already been selected 
4. Source of Subjects (including patients): 
1. Participants of intervention: all participants: The Crow Indian Reservation and outlying areas including 
Hardin, MT. 
2. Participants of intervention: subgroup: The Crow Indian Reservation and outlying areas including Hardin, 
MT. 
3. Intervention facilitators: these individuals have already been selected and are members of the Crow Nation 
who live on or near the reservation. 
5. Who will approach subjects and how? Explain steps taken to avoid coercion. 
1. Participants: Local community members from the Crow Reservation who will serve as intervention facilitators 
and local community members from the Crow Reservation who are staff members of the grant 
project will talk with potential participants about the project to assess their interest. They will 
approach community members they already know - family members, friends, clan members. 
Potential participants will be given a brochure that explains the project and one of two handouts that 
graphically depict the activities in which they will participate. The facilitator or staff member will 
review the handout, describing the study design and expectations of being enrolled in the project. If 
the community member expresses interest in being a part of the study, the facilitator or staff 
member will record their name and contact information. The project will also hold community 
meetings and tabling events to recruit potential participants and post information that is on the 
brochure in public locations in the community. As Messengers for Health has a positive record in 
the community, community members also are asking project staff members to be included in this 
intervention. There will be no coercion to participate. A copy of the brochure and graphic handouts 
are included with these materials. 
2. Participants of intervention: subgroup: these participants will already be enrolled in the study. After the 
names are randomly selected, a project staff member or facilitator/mentor will ask the participant if 
they are interested in taking part in the qualitative interview after they have completed the 

intervention. 
3. Intervention facilitators: these individuals have already been selected and are members of the Crow Nation 
who live on or near the reservation. 
6. Will subjects receive payments, service without charge, or extra course credit? 
Yes or No 
(If yes, what amount and how? Are there other ways to receive similar benefits?) 
1. Participants: Participants will receive a $40 gift card each time they complete the surveys and exercises. 
Participants will receive a $10 gas card for each of the 7 intervention meetings/gatherings. 
2. Participants of intervention: subgroup: will receive a $30 gift card for their participation. 
3. Intervention facilitators: will receive a $225 payment each month leading up to and through the intervention. 
1, 2, & 3: There are no other ways to receive similar benefits. 
7. Location(s) where procedures will be carried out. 
1, 2, & 3: On the Crow Indian Reservation and in Hardin Montana in public community sites such as 
community centers, senior citizen centers, churches, and schools. 
E. RISKS AND BENEFITS (ADVERSE EFFECTS) 
1. Describe nature and amount of risk and/or adverse effects (including side effects), substantial 
stress, discomfort, or invasion of privacy involved. 
1, 2, 3: While there is always a possibility that participants may experience discomfort completing the 
measures, there is a low possibility of this occurring as the result of the proposed project because a) 
Apsaalooke community members have approved of all measures through a collaborative process and they do 
not believe that the measures involve an invasion of privacy or would provoke discomfort and b) all of the 
measures used in this study have been used in other populations. We do not anticipate that the three 
exercises that participants will be performing would cause stress or discomfort. Participants are encouraged to 
do the exercises as a pace and level that is comfortable for them. The consent form states that they do not 
have to answer any question they are not comfortable answering and do not have to do any exercises that they 
do not want to do. 
During one of the gatherings, there will be a discussion of grief, loss, resilience, and healing. Should any 
participants experience an adverse psychological reaction, intervention facilitators and project staff involved in 
data gathering will be trained by Dr. Earl Sutherland (a psychologist from our clinic partner, Big Horn Valley 
Health Center), to evaluate the situation and, if necessary, make appropriate referrals. Referrals will be made 
to BVHC, Indian Health Service or other mental health providers in the community for psychological 
assistance. Participants will be provided with a list of resources available in the local communities. 
2. Will this study preclude standard procedures (e.g., medical or psychological care, school 
attendance, etc.)? If yes, explain. 
1, 2, & 3: No. 
3. Describe the expected benefits for individual subjects and/or society. 
1, 2, & 3: Participants in the Baa niilah intervention groups may receive benefits of learning from each other 
and from the intervention facilitator on how to improve their chronic illness management. Our hope 
is that the proposed intervention will lead to improved management and that this intervention can be 
disseminated to other Native American communities in order to assist with chronic illness self-
management strategies. The intervention methods are built upon strengths of the Apsaalooke 
culture and are culturally sensitive to ways of knowing and interacting. As a result of our culturally 
sensitive approach, the intervention meetings are likely to be a pleasurable experience for the 

participants. 
Health statistics of Montana's Native American populations show significant health disparities that require 
effective interventions; however, intervention strategies with Native Americans that focus on chronic illness 
self- management are severely lacking. By adapting, testing, and disseminating an effective intervention that is 
based in the Apsaalooke Indian culture, there will be a reduction of negative consequences of chronic illness in 
this population, as well as meaningful information gained, which will inform other research and practices. 
F. ADVERSE EFFECTS 
Information for F, ADVERSE EFFECTS, is the same for participant groups 1, 2, & 3. 
1. How will possible adverse effects be handled? 
By investigator(s ): 
Referred by investigator(s) to appropriate care: xx. It states in the consent form: "In the event your participation 
in this research supported by the National Institutes of Health results in injury to you, medical treatment 
consisting of referral to Indian Health Services or Bighorn Valley Health Center will be available. If it is an 
emergency, a project mentor or staff member will call 911. This treatment will be at your expense. Further 
information about this treatment may be obtained by calling Alma McCormick at 665-5492 or Suzanne Held at 
Montana State University at 994-6321." 
Other (explain): 
2. Are facilities/equipment adequate to handle possible adverse effects? 
Yes or No 
(If no, explain.) 
3. Describe arrangements for financial responsibility for any possible adverse effects. 
MSU compensation (explain): 
Sponsoring agency insurance: 
Subject is responsible: xxxx - this is stated in the consent form. 
Other (explain): 
G. CONFIDENTIALITY OF RESEARCH DATA 
1. Participants: For all data collected, the HELPS Lab at MSU will manage the uploaded data. All HELPS Lab 
personnel have completed the appropriate CITI human subjects training. Once the data are downloaded from 
the secure Qualtrics servers, they will be stored on Box, which is password protected. Any index files that link 
individual names or addresses to identification codes will be stored separately on Knox, which has an even 
higher degree of security. Transfer of data to other researchers affiliated with the project will happen by 
granting subfolder access via Box. All participants will be assigned ID numbers with names that will be 
maintained in locked and secure files. 
2. Participants of intervention: subgroup: As is standard protocol for qualitative interviews with our project, we 
will ask each participant if they would like their name attached to their interview or if they would like to remain 
anonymous. The interviews will be recorded and transcribed and kept confidential or no according to the 
wishes of the participant. The recordings and transcriptions will be kept in Box. 
1. Will data be coded? 
Yes or No 
2. Will master code be kept separate from data? 
Yes or No 
3. Will any other agency have access to identifiable data? 
Yes or No 
(If yes, explain.) 
4. How will documents, data be stored and protected? 

Locked file: 
Computer with restricted password: xx - Data will be stored on computer tablets, which will be 
password protected. The computer tablets will be stored together in two locked traveling cases. 
Other (explain): 
VIII. Checklist to be completed by lnvestigator(s) 
A. Will any group, agency, or organization be involved? 
Yes or No 
(If yes, please confirm that appropriate permissions have been obtained.) 
This grant has subcontracts with, 1) Messengers for Health, which is a 501 c3 non-profit organization located 
on the Crow Reservation, 2) University of Nevada Las Vegas, where our biostatistician is located, and 
3) University of Hawaii, where a mentor is located. We also partner with Big Horn Valley Health 
Center, a community health center and clinic partner just off the Crow Reservation. BVHC is primarily 
involved to provide training to intervention facilitators. 
B. Will materials with potential radiation risk be used (e.g. x-rays, radioisotopes)? 
Yes or No 
1. Status of annual review by MSU Radiation Sources Committee (RSC). 
Pending or Approved 
(If approved, attach one copy of approval notice.) 
2. Title of application submitted to MSU RSC (if different). 
C. Will human blood be utilized in your proposal? 
Yes or 
No 
(If yes, please answer the following) 
1. Will blood be drawn? 
Yes or No 
(If yes, who will draw the blood and how is the individual qualified to draw blood? 
What procedure will be utilized?) 
2. Will the blood be tested for HIV? 
Yes or No 
3. What disposition will be made of unused blood? 
4. Has the MSU Occupational Health Officer been contacted? 
Yes or No 
D. Will non-investigational drugs or other substances be used for purposes of the research? Yes or No 
Name: 
Dose: 
Source: 
How Administered: 
Side effects: 
E. Will any investigational new drug or other investigational substance be used? 
Yes or No 
[If yes, provide information requested below and one copy of: 1) available toxicity data; 2) reports of animal studies; 3) 
description of studies done in humans; 4) concise review of the literature prepared by the investigator(s); and 5) the drug 
protocol.] 
Name: 
Dose: 
Source: 
How Administered: 
IND Number: 
Phase of Testing: 
F. Will an investigation al device be used? Yes or No 
(If yes, provide name, source description of purpose, how used, and status with the U.S. Food and Drug 
Administration FDA). Include a statement as to whether or not device poses a significant risk. Attach any 
relevant material.) 

G. Will academic records be used? Yes or No 
H. Will this research involve the use of: 
Medical, psychiatric and/or psychological records Yes or No 
Health insurance records 
Yes or No 
Any other records containing information regarding personal health and illness 
Yes or No 
If you answered "Yes" to any of the items under "H.", you must complete the HIPAA worksheet. 
I. 
Will audio-visual or tape recordings or photographs be made? 
Yes or No 
1 & 3: NO 
2. Participants of intervention: subgroup: Yes. As is standard protocol for qualitative interviews with our project, 
we will ask each participant if they would like their name attached to their interview or if they would like to 
remain anonymous. The interviews will be recorded and transcribed and kept confidential or not according to 
the wishes of the participant. The recordings and transcriptions will be kept in Box. 
J. Will written consent form(s) be used? (Yes or No. If no, explain.) (Please use accepted format from 
our website. Be sure to indicate that participation is voluntary. Provide a stand-alone copy; do not 
include the form here.) 

Protection of Human Subjects 
This Human Subjects Research meets the definition of a clinical trial. 
The protocols for the project will be submitted for primary review to the Little Big Horn College (LBHC) 
Institutional Review Board and secondarily to the Montana State University (MSU) Institutional Review Board. 
LBHC will be the primary IRB of record. The investigators for the Baa nnilah project may be interested in 
applying for a Certificate of Confidentiality through NIH and will investigate this possibility prior to applying 
for human subjects approvals. 
One metric of partnerships in community-based participatory research is "who owns the data?" The data 
gathered from this study will be housed at Montana State University, as it has the ability to securely store the 
data. At this time, the Apsaalooke Nation does not have the capacity to securely store the data. The PDs/Pis 
from this project are involved in a separate project that has the goal of enabling secure ownership, control, 
access, and possession of data on the reservation site. We will work with the Apsaalooke Nation to provide 
useful data from this project, which may be used to assist the tribe with their current and future health 
projects. 
Risks to human subjects 
a. Human subjects involvement, characteristics and design 
Participants in this study will consist of American Indian (AI) community members who live on or near the 
Apsaalooke reservation, age 25 and older who have a chronic illness. Two hundred (200) participants shall be 
enrolled, 100 male participants and 100 female participants. Inclusion criteria for screening of participants 
include a);;, 25 years, b) AI, and c) diagnosed with diabetes, hypertension, osteoporosis, liver disease, chronic 
lung disease (asthma, chronic bronchitis or emphysema), heart disease (coronary artery disease or congestive 
heart failure), stroke (completed cerebrovascular accident with neurologic handicap and normal mentation), or 
chronic arthritis. In addition to at least one of the above conditions, they could have other conditions. CAB 
members were strong in their desire to be inclusive in the list of Cis for which individuals will be eligible to be 
in the study. This list matches other widely accepted evidence-based self-management programs in the US. 
Potential participants will be excluded if they have an advanced terminal condition that precludes 
participation. 
The Bighorn Valley Health Center (BVHC), a Federally Qualified Health Center located in Hardin, Montana, 
represents the primary site where the research will be performed. 
Recruitment and study orientation: Intervention mentors (Aakbaabaaniilea) will take the lead in participant 
recruitment, using the strength of Iishamaaalaxxia, the Apsaalooke clan system, of which everyone is a part. 
The Aakbaabaaniilea will meet as a group with Ms. McCormick and bring to the meeting a list of potential 
participants of the same gender, in keeping with respectful kinship relationships. Since the community is very 
close knit, Aakbaabaaniilea will know who has or does not have a CL Use of Iishamaaalaxxia and care in 
Aakbaabaaniilea selection will ensure that there will not be overlap among the list of potential participants. 
The meeting between theAakbaabaaniilea and Ms. McCormick will cover participant recruitment, which 
includes contacting potential participants to explain the study and asking if they wish to be involved in the 
project. TheAakbaabaaniilea will be trained to randomly assign participants to the intervention group or wait-
list group using a permuted block randomization protocol with 10 groups in each condition and 10 participants 
per group. The 10 groups (per condition) will be conducted at the same time, for a 4-month period to allow for 
7 meetings approximately every two weeks (See Tables 5 and 8 of the Research Strategy section). 
Aakbaabaaniilea will keep a log of refusals and reasons for refusing, and will recruit until they have 10 
participants (each) in the intervention and wait-list group. Building the groups in this manner is also 
appropriate as clan relatives mentor each other and visit often. This team used a culturally-based survey 
recruitment procedure in another intervention study that yielded a 98% participation rate. We also anticipate a 
very high acceptance rate for this project due to multiple community members reaching out to Ms. McCormick 
and asking to be involved in the study. Also, the tradition of having compassion, empathy, and respect for 
relatives and a 19-year history of working in the community will lead to successful recruitment and retention. 

Participant retention: Aakbaabaaniilea will check in with participants via telephone on a weekly basis to 
remind them of upcoming intervention meetings and to problem-solve any issues. It is estimated that the 
current community-based leadership role oftheAakbaabaaniilea in the community and the relationships 
established through the intervention will contribute to participant retention. We will provide incentives that 
have worked in our past intervention research with the Apsaalooke Nation, including gas vouchers to assist 
with transportation to and from the intervention site and by holding a graduation at the end of the intervention 
where participants who complete the program will receive a larger gift incentive. Our CAB believes that the 
culturally consonant intervention and the long-standing partnership will be strong incentives to keep program 
participants engaged. In our Messengers for Health study, community members consistently attended monthly 
meetings for the entire intervention period, which was 5 years. 
b. Sources of materials 
Data will consist of: 
1. 
Quantitative measures of: demographic information, quality of life, physical function, satisfaction with 
participation in social roles, satisfaction with social roles and activities, social isolation, psychosocial 
impact of illness, emotional distress, health care relationship trust and patient activation. 
2. Qualitative data on fidelity and acceptability of the Baa nnilah intervention. Data that has individually 
identifiable private information about human subjects will be managed primarily by the PI/PDs (Dr. 
Suzanne Christopher and Ms. Alma Knows His Gun McCormick). The faculty at the Montana State 
University Human Ecology Learning and Problem Solving (HELPS) Lab will receive the data in order to 
de-identify all data before the analysis phase is initiated. The PI/PDs and faculty ofthe HELPS lab have 
undergone Collaborative IRB Training Initiative (CITI) training for human subjects research. Further, 
research team members will have completed a research ethics training course required by the IRBs 
prior to contact with potential project participants. 
c. 
Potential risks 
While there is always a possibility that participants may experience discomfort completing the measures listed 
above, there is a low possibility of this occurring as the result of the proposed project because Apsaalooke 
community members have approved all measures in advance of the study through a collaborative process. 
However, should any participants experience an adverse reaction, interventionAakbaabaaniilea (Mentors) 
and project staff involved in data gathering will be trained by Dr. Earl Sutherland and other mental health staff 
from our clinical partner, BVHC, to evaluate the situation and, if necessary, make appropriate referrals. 
Referrals will be made to BVHC or other mental health providers in the community. 
Adequacy of protection against risks 
a. Recruitment and informed consent: For all data points, we will seek and obtain fully informed consent by 
each participant before she/he takes part in the proposed intervention. Montana State University requires the 
Collaborative IRB Training Initiative (CITI) online course; as stated above, all per Montana State University 
requirements, research team members will have completed a research ethics training course required by the 
IRBs prior to contact with potential participants. We will write all consent forms and explanatory scripts in 
plain language English at an eighth-grade reading level. Project partners have co-written multiple human 
subjects consent forms for prior studies, which are attuned to the Apsaalooke culture. No one will be coerced or 
pressured to take part in the proposed project. If any research team staff believes a person does not fully 
understand the project or rights as a research participant, we will explain further until the person understands, 
or we will not permit the person to take part. The content of the verbal explanation, consent process, and 
consent form will fully disclose our project's purpose, procedures, and requirements, and describe the potential 
risks of our project as noted above. That consent will also inform the person of his/her rights as a research 
participant, including: 
1. Participants do not have to participate; their participation in the research project is voluntary; 
2. Participants do not have to answer any questions or participate in any procedure they do not want to; 
3. Participants can stop the process at any time, and continue later or not continue at all; 
4. All information they share will be strictly confidential. Their names will not be given out or connected 
with any information shared publicly about the project by the Pls or members of the research team; and, 
5. Their care at Bighorn Valley Health Center will not be impacted by agreeing or not agreeing to 
participate in the study. 

Once they have read the consent form (or had the form read to them) in English, understand their rights, and 
agree to participate, we will ask them to sign the consent form and we will give them a copy. 
b. Protections again risk: Community partners have reviewed and edited or revised all questionnaires and 
surveys in order to increase protection against risk. Should any participants experience an adverse reaction 
during the assessments or intervention in spite of this collaboration, intervention Aakbaabaaniilea and other 
project staff will be trained to evaluate the situation and, if necessary, make appropriate referrals. Our clinical 
partner, BVHC, has agreed to accept referrals from this study and to train our community intervention 
Mentors on how to evaluate their mentees for mental health referral needs (see their letter of support). BVHC 
has mental health specialists on staff, including Dr. Earl Sutherland, who is a part of our research team. We will 
follow rigorous methods to insure participant confidentiality. The co-investigators and all assistants have had 
or will receive training on confidentiality and ethical research conduct. 
Confidentiality of data will be maintained by the numerical coding and stripping of identifying information of 
all data upon transfer to Montana State University and the University of Nevada-Las Vegas. As stated above, 
the Montana State University HELPS lab will be responsible for this action as well as for secure transmission of 
data to Dr. Feng at University of Nevada-Las Vegas. The data will be kept in the private offices of Dr. 
Christopher and Dr. Feng. Data will be entered into tablets and the tablets will be secured in a locked cabinet at 
Ms. McCormick's office. Data from the tablets will be downloaded onto a disk and personally transported to 
MSU. After the study is completed, the tablets with the data files will be personally transported back to MSU by 
one of the Pis and secured in a locked cabinet. All subjects will be assigned ID numbers with names that will be 
maintained in locked and secure files by Dr. Christopher. Additionally, all data will be stored in locked file 
drawers at each stage of data transfer. Moreover, all data obtained will be accessible only to the research staff, 
and no subject will be identified in any report of the project. The intervention Mentors, Project Assistant, and 
research assistants will be thoroughly versed in ethical issues associated with this research, with specific 
attention to confidentiality, and will be IRE certified by MSU. All research staff will sign a formal oath of 
confidentiality as part of their employment contract. 
We will only disclose information we receive from subjects about intended physical harm to potential victims to 
the responsible authorities. We consider it our responsibility to inform authorities and to protect the well-being 
of potential victims; this is also the state law in Montana. 
Potential benefits of the proposed research to human subjects and others 
Participants will share their health stories with their Aakbaabaaniilea and with other members of their 
intervention group. In our preliminary study, we found that this was perceived by participants to be a 
beneficial experience. Participants in the Baa niilah intervention groups may receive benefits oflearning from 
each other and from their Mentor on how to improve their chronic illness management. Our hope is that the 
proposed intervention will lead to improved management and that this intervention can be disseminated to 
other Native American communities in order to assist with chronic illness self-management strategies. The 
intervention methods are built upon strengths of the Apsaalooke culture and are culturally sensitive to ways of 
knowing and interacting. As a result of our culturally sensitive approach, the intervention meetings are likely to 
be a pleasurable experience for the participants. 
Importance of the knowledge to be gained 
Health statistics of Montana's Native American populations show significant health disparities that require 
effective interventions; however, intervention strategies with Native Americans that focus on chronic illness 
self- management are severely lacking. By adapting, testing, and disseminating an effective intervention that is 
based in the Apsaalooke Indian culture, there will be a reduction of negative consequences of chronic illness in 
this population, as well as meaningful information gained, which will inform other research and practices. 
Data safety and monitoring plan (DSMP) 
Using definitions and information in the June 10, 1998 NIH Policy for Data Safety and Monitoring, we consider 
this study to meet the criteria for a Phase III clinical trial as we are conducting an effectiveness trial where we 
are comparing a new treatment (Baa niilah intervention) to usual care and in which participants will be 
followed for 12-months post-intervention. This is a single-site study. We agree to work with the IC that will be 
funding this study regarding their roles and responsibilities listed in the policy, to include: 
• 
Prepare or ensure the establishment of a plan for data and safety monitoring for all interventional 

trials; 
• 
Conduct or delegate ongoing monitoring of interventional trials; 
• 
Ensure that monitoring is timely and effective and that those responsible for monitoring have the 
appropriate expertise to accomplish its mission; 
• 
Oversee monitoring activities; and, 
• 
Respond to recommendations that emanate from monitoring activities. 
The website listing specific institute/ center policy and guidance 
(http://grants.nih.gov/grants/policy/hs/data_safety.htm) does not include guidance for NIMHD, so we used 
the 1998 Policy document and the Policy ofNINRfor Data and Safety Monitoring of Extramural Clinical 
Trials dated 2014 to prepare this DSMP. 
Data Safety and Monitoring Plan (according to NINR 2014 guidance): 
A.1 Monitoring entity or who will monitor the study: The Principal Investigators, Dr. Christopher and Ms. 
McCormick will be responsible for knowing the policies of the Apsaalooke Nation community and the 
Institutional Review Boards (IRBs) for LBHC and MSU. The Pis will adhere to IRE policies and maintain 
accurate documentation ofIRB correspondence and reports (e.g., annual report). Dr. Christopher will be the 
lead on IRE correspondence and reports. 
A.2 Purpose ofthe Data Safety Monitoring Board: In accordance with NINR policy and procedures, the 
Baa nnilah Project is required to establish a DSMB to serve as an independent group that will 
evaluate the data on an ongoing basis to assure participant safety and study integrity. The Baa nnilah Project 
DSMB will provide a data monitoring function above and beyond that traditionally assumed by the 
institutional review boards that oversee the project, that is, the LBHC and MSU - Committee on Human 
Studies. Although this is a relatively "low risk" intervention, we recognize the need to monitor all 
patients in this study to ensure the safety of participants and assure the quality of the research. 
A.3 Members of the Baa nnilah Project DSMB: According to the NIH Policy for Data Safety and Monitoring, "A 
monitoring committee is usually required to determine safe and effective conduct and to recommend 
conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded 
successfully." Upon funding, we will recruit a minimum of three (3) members for the DSMB in accordance with 
NIH and IC policies. We will recruit individuals to ensure representation ofthe appropriate areas of expertise 
to consider patient safety and proper study conduct. Areas of expertise will include: a) chronic illness 
management; b) clinical trials; and, c) research with American Indian populations. 
Supporting members of the DSMB include: 1. Dr. Suzanne Christopher (PI), 2. Ms. Alma McCormick (PI), 3. 
Dr. Du Feng, (Co-investigator and project biostatistician), 4. Dr. Jillian Inouye, (Co- investigator), and 5. Dr. 
David Mark (Co- investigator and clinical partner). 
A.4 Roles and Responsibilities: We will abide by the NIH 1998 policy guidance and have our board perform the 
following activities: 
• 
Review the research protocol and plans for data and safety monitoring; 
• 
Evaluate the progress ofinterventional trial(s), including periodic assessments of data quality and 
timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance 
of trial sites, and other factors that can affect study outcome. Monitoring should also consider factors 
external to the study when interpreting the data, such as scientific or therapeutic developments that 
may have an impact on the safety of the participants or the ethics of the study; 
• 
Make recommendations to the IC, IRE, and investigators concerning continuation or conclusion of the 
trial(s); and, 
• 
Protect the confidentiality of the trial data and the results of monitoring. 
We will abide by NIH policy, and have the data and safety monitoring board (from the 1998 policy guidance): 
• 
Meet first in open session, attended by selected trial investigators (Dr. Christopher and Ms. 
McCormick) as well as NIH program staff or project officers (as available) and perhaps industry 
representatives, and then in closed session where they review emerging trial data; 

• When "masked" data are presented or discussed, no one with a proprietary interest in the outcome will 
be allowed. Participants in the review of "masked" or confidential data and discussions regarding 
continuance or stoppage of the study will have no conflict of interest with or financial stake in the 
research outcome. However, ifthere is an open session, they could be present; and, 
• 
Confidentiality will be maintained during all phases of the trial including monitoring, preparation of 
interim results, review, and response to monitoring recommendations. Besides selected NIH program 
staff, other key NIH staff, and trial biostatisticians, nsually only voting members of the DSMB will see 
interim analyses of outcome data. Exceptions may be made under circumstances where there are 
serious adverse events, or whenever the DSMB deems it appropriate. 
B.1 Procedures for monitoring study safety: Aakbaabaaniilea (Mentors) and Pis will hold weekly 
teleconference meetings in order to discuss intervention meetings and to monitor study safety. The community 
PI (McCormick) will be available via cell phone to intervention mentors in between teleconference calls in the 
case of an event that requires discussion. Intervention Mentors will be trained in this manner. 
B.2 Procedures for minimizing research-associated risk: Community partners have reviewed and edited or 
revised all questionnaires and surveys in order to increase protection against risk. Community partners have 
also co-developed all study protocols with minimization of risk in mind. We will also hold community meetings 
in the first 6-months of the study to gather input and suggestions and will include minimizing risk as a subject 
of discussion. Should any participants experience an adverse reaction during the assessments or intervention 
in spite of this collaboration, intervention Mentors and other project staff will be trained to evaluate the 
situation and, if necessary, make appropriate referrals. Our clinical partner, BVHC, has agreed to accept 
referrals from this study and to train our community intervention Mentors on how to evaluate their mentees 
for mental health referral needs (see their letter of support). BVHC has mental health specialists on staff. We 
will follow rigorous methods to ensure participant confidentiality. The Co-investigators and all assistants have 
had or will receive training on confidentiality and ethical research conduct. 
B.3 Procedures for protecting the confidentiality of participant data: Confidentiality of data will be maintained 
by the numerical coding and stripping of identifying information of all data upon transfer to MSU and the 
University of Nevada-Las Vegas. The MSU HELPS lab will be responsible for this action and for secure 
transmission of data to Dr. Feng at University of Nevada-Las Vegas. The data will be kept in the private offices 
of Dr. Christopher and Dr. Feng. Data will be entered into tablets and the tablets will be secured in a locked 
cabinet at Ms. McCormick's office. Data from the tablets will be downloaded onto a disk and personally 
transported to MSU. After the study is completed, the tablets with the data files will be personally transported 
back to MSU by one of the Pis and secured in a locked cabinet. All subjects will be assigned ID numbers with 
names that will be maintained in locked and secure files by Dr. Christopher. Additionally, all data will be stored 
in locked file drawers at each stage of data transfer. Moreover, all data obtained will be accessible only to the 
research staff, and no subject will be identified in any report of the project. The intervention Mentors, Project 
Assistant, and research assistants will be thoroughly versed in ethical issues associated with this research, with 
specific attention to confidentiality, and will be IRB certified by MSU. All research staff will sign a formal oath 
of confidentiality as part of their employment contract. 
C. 1. Procedures for identifying, reviewing, and reporting adverse events and unanticipated problems to the 
IRB and NIH IC. 
Procedures and timeline for reporting Adverse Effects to the IC 
Reporting Procedure for Serious Unanticipated Adverse Events: In the event of an unanticipated serious 
adverse event, the project Pis will ensure that these events are reported to the IC Program Official within hours 
by phone, fax, and/ or email and will submit a written report to the Program Official no more than two days 
later. The project personnel will also utilize the following reporting procedures: 
1. When the research team, project personnel and /or Pis become aware of a serious adverse event, 
reporting requirements must be implemented in a timely manner; 
2. The Pis complete an "Adverse Event Reporting Form" and submit the form to the Human Subjects 
Officer at MSU and LBHC; 

3. The Human Subjects Officer immediately distributes the form to the following individuals or groups as 
required: Division of Sponsored Research; the Data and Safety Monitoring Committee;, and, the MSU and 
LEHC IRE Officials; 
4. The Human Subjects Officer will convene an expedited meeting of the IRE. The IRE, with input from the 
Pis and the Data and Safety Monitoring Committee, will review the study protocol and determine what 
further action should be taken based on the best interests of the participants and of the research; and, 
5. The Pis will report any actions taken by an IRE. 
Critical problems: A protocol for identifying, reviewing, and reporting will be put into place in 
the eveut of any of the following critical problems: 
1. Increased morbidity and/ or mortality related to the study intervention; 
2. Adverse reactions to the educational intervention; 
3. Unsatisfactory performance ofthe study; 
4. Suspicion of fraud; 
5. Failure to comply with recruitment criteria; and/or 
6. Any other issues that would require an important protocol change 
Notification of any critical problems may be done initially through telephone but must be subsequently 
documented in writing either through e-mail or postal mail correspondence. 
D. For multi-site studies, procedures to ensure compliance with monitoring plan and reporting requirements 
across study sites: This does not apply as this study is a single-site study. 
E. Assessment of external factors or relevant information that may have an impact on the safety of participants 
or on the ethics for the research study: The Apsaalooke community-based PI, Ms. McCormick will take the lead 
on this assessment. 
F. Advanced plans for interim and/ or futility analysis as appropriate: This is not appropriate. 
Inclusion of Women and Minorities 
1. Describe the planned distribution of subjects by sex/gender, race, and ethnicity for the proposed study and 
complete the format in the Planned Enrollment Report: Planned enrollment report is complete and in the 
application. There will be an estimated 100 men and 100 women who are all American Indian enrolled in 
the study. Additional guidance for research utilizing existing datasets: We are not using existing datasets 
2. Describe the subject selection criteria and rationale for selection of sex/gender, racial, and ethnic group 
members in terms of the scientific objectives and proposed study design: The description may include, but 
is not limited to, information on the population characteristics of the disease or condition under study. The 
study is being conducted on an American Indian reservation, thus the subjects will be American 
Indian. Inclusion criteria for screening of participants include a) <: 25 years, b) Chronic Illness diagnosis, 
and c) American Indian. Men and women will be recruited equally. 
3. Provide a compelling rationale for proposed sample specifically addressing exclusion of any sex/gender, 
racial, or ethnic group that comprises the population under study (see examples below): There are no 
exclusions of sex/gender, racial, or ethic group that comprises the population under study. The population 
under study consists of American Indians. The partnership for this research grant consists of a university 
and a tribal nation, so it is appropriate that the population under study consists of members of the tribal 
nation partner. 
4. Describe proposed outreach programs for recruiting sex/gender, racial, and ethnic group members as 
subjects: Members of the tribal nation will conduct the recruiting of subjects. Also, as appropriate to this 
tribal nation, same gender tribal members will recruit same gender subjects. 
5. Regarding clinical trials: To meet the requirements of section 4.2.1, we plan to conduct valid analyses of the 
intervention effect on men and women separately. Prior studies neither support nor negate significant 

-
---------------
-----~-------~---------
differences in intervention effect among subgroups. We will not conduct valid analyses by racial or ethic 
subgroups as all subjects will be American Indian. 
Inclusion of children 
There will be no data gathered from children. 
Justifications for Exclusion of Children: The justification for exclusion of children is #1 of the list of 
justifications, "the research topic to be studied is not relevant to children." 

Measures 
Data Gathering Meeting 
Program staff member - introduce self and other staff members: 
First of all, I would like to welcome each one of you and thank you for participating in our Baa 
nnilah program. Your being here shows the commitment to your health and our community. 
This program grew from the desires and interests of the Crow community to encourage and 
support people with ongoing health conditions to take good care of ourselves and in turn to 
support each other. We would like to ask one of the elders to provide an opening prayer to 
bless the gathering and the meal. 
While people are eating, have them introduce each other and where they are from and one thing 
they are looking forward to receiving from the program. Provide the handout with the topics 
and dates of the 7 gatherings. 
Here is a handout that shows the topics and dates for our 7 gatherings. We encourage you to 
come on time, stay until the end of each gathering, and to attend each of the 7 gatherings. 
The gatherings will be about 3 hours long. The success of Baa nnilah in improving our health 
and the health of our communities comes from each of us dedicating ourselves to working 
together and supporting each other. 
In the Baa nnilah program, you will: 
• 
Gain knowledge and tools for healthy living and self-care to improve your quality of life. 
• 
Learn from mentors and other program members. 
• 
Share and apply Crow cultural strengths to address ongoing health concerns. 
• 
Learn about nutrition and physical and emotional health tools and exercises through 
hands-on activities. 
• 
Gain support and help from program staff and other participants to apply what is learned 
to your self-care. 
Today we will complete a survey using computer tablets and we will do 3 exercises. The purpose 
of the survey and exercises is to help us learn how the program is progressing and what we can 
do to make it better. We will be reading the questions on the survey out loud and you will see the 
questions on the computer screen. You will respond to the questions by touching the screen. If 
you have a question, please raise your hand and someone will come to help you. 
We thank you very much for sharing with us today. We hope you will share your true feelings, 
for there are no right or wrong answers to these questions. The information you share with 
Messengers for Health will be kept confidential and your name will not be on this survey. We 
have arranged the computer tablets so that no one will see your responses. 
Arrange participants so that their computer screens are private and other participants cannot see 
their screens. A staff member will be at the front and will read each question out loud. Other staff 
1 

members will remain located so thatthey .do hot See the participant's computer screens and will 
remain ready to assist as needed. 
The first questions ask some information about you. 
QI. Which community do you live in? 
I. Lodge Grass 
2. Fort Smith (Big Horn District) 
3. St. Xavier (Big Horn District) 
4. Pryor 
5. Crow Agency (Reno District) 
6. Wyola 
7. Garryowen (Reno District) 
8. Hardin 
9. Dunmore (Black Lodge District) 
10. Other -------
Q2. What is your current marital status? 
1. Married or living in a marriage-like relationship 
2. Separated 
3. Divorced 
4. Widowed 
5. Single, never married 
6. Other -------
Q3. What was the highest grade or year of school that you completed? 
1. Eighth grade or less 
2. Some high school 
3. High school graduate or diploma 
4. Some technical/vocational school 
5. Technical/vocational school graduate 
6. Some college 
7. 2-year college graduate (associate's degree) 
8. 4-year college graduate (bachelor's degree) 
9. Post graduate or professional degree 
Q4. What is your year of birth? __ 
Q5. Employment Status: Are you currently ... ? 
1. Employed for wages, full time ( 40 hours or more per week) and not a student 
2. Employed for wages, part time (less than 40 hours per week) and not a student 
3. Out of work 
4. A homemaker/Carrying for family 
5. A student and not working 
6. A student and employed for wages, full time ( 40 hours or more per week) 
7. A student and employed for wages, part time (less than 40 hours per week) 
2 

8. Retired 
9. 
Unable to work 
Q6. Please select the number that shows how much your total household income 
was for the past 12 months. Household means all of the people who live with you and share 
income and expenses. 
1. Under $10,000 
2. $10,000-$19,999 
3. $20,000-$29,999 
4. $30,000-$39,999 
5. $40,000 and over 
Q7. Including yourself, how many people are living in your household at this time? __ 
Q8. Where do you receive most of your health care? 
1. Indian Health Service 
2. Bighorn Valley Health Center 
3. Hardin Clinic/St. Vincent's Health Care 
4. Billings Clinic 
5. Other 
Q9. About how many miles do you travel to get to the clinic where you receive your health care? 
Ql 0. Please select the type of health insurance or health coverage that pays for your health care. 
Select all that apply: 
1. Medicare/Medicaid 
2. Private insurance 
3. II-IS only 
4. Other -------~ 
Q 11. Does anyone in your household receive benefits from a food assistance program such as 
WIC, Commodities, SNAP, EFNEP? 
1. Yes 
2. No 
Ql2. Please select the ongoing illness( es) that a doctor has told you that you have. Please select 
all that apply. 
1. Diabetes 
2. Arthritis 
3. Heart disease 
4. High blood pressure 
5. Asthma 
6. Cancer 
7. Chronic pain 
8. Other (they can type in others) 
3 

Q 13. What is your gender? 
1. Female 
2. Male 
3. Other ----
This question is for the wait-list control group to be included with the March 2018 data gathering 
Q. The Messengers for Health Baa nnilah program consists of7 gatherings in the local Crow 
communities and Hardin that are led by a community member mentor. Have you taken action for 
your health based on something you have learned from a friend or family member who has 
attended the gatherings? 
1. Yes 
2. No 
These questions are for afterparticipants have completed the intervention: 
-----
---------~=~----
-------·~----
--~---
-- --- .. 
_. -- --·;--·-----
I felt like my mentor cared 
very much 
somewhat 
a little 
not at all 
about or was concerned 
about me. 
- - -- ----
-- -------------------------
I felt like the other 
participants in my Baa 
nnilah group cared about or 
were concerned about me. 
very much 
somewhat 
----------------------------
-
-
---- ---------------------------- ------------
! felt safe and comfortable 
very much 
somewhat 
to openly express my 
feelings in my_gr()!lJlc 
I trusted that what I shared 
very much 
in my group would be kept 
confidential and not shared 
with others. 
After participating in the 
Baa nnilah program, I feel 
more hopefu1, ________ _ 
I would recommend the 
Baa nnilah program to 
very much 
definitely 
would 
somewhat 
somewhat 
probably 
would 
a little 
a little 
a little 
a little 
probably 
would not 
not at all 
not at all 
not at all 
not at all 
definitely 
would not 
Very helpful 
. Somewhat 
·A little 
Not at all 
_J~ie11~s ()!family members 
The Baa nnilah program 
was helpful to me 
Gathering 1, with the 
purpose of sharing how the 
program grew from the 
desires and interests of the 
Crow community to 
provide support to 
community members with 
ongoing illnesses, to 
become familiar with the 
. helpful _ _______ _ _ _ _li~lpfll_l______ 11_elpfu_l ______ _ 
Very helpful 
Somewhat 
. A little 
Not at all 
helpful 
helpful 
helpful 
-- --
---------------------
---------------------------~-
4 

program, and to foster and 
encourage an atmosphere 
of safety and hope was 
. helpful to me. 
Gathering 2, with the 
Very helpful 
Somewhat 
A little 
Not at all 
purpose of gaining 
helpful 
helpful 
helpful 
knowledge of ongoing 
health conditions and self-
carewas helpful to me. 
Gathering 3, with the 
Very helpful 
Somewhat 
A little 
Not at all 
purpose of better 
helpful 
helpful 
helpful 
understanding the personal 
impacts of historical and 
current trauma and loss and 
how traditional cultural 
values and resilience help 
to heal and overcome loss 
and trauma was helpful to 
me. 
Gathering 4, with the 
Very helpful 
Somewhat 
A little 
Not at all 
purpose of learning about 
helpful 
helpful 
helpful 
healthy food and physical 
activity was helpful to me. 
- -------
Gathering 5, with the 
Very helpful 
Somewhat 
A little 
Not at all 
purpose of showing how to 
helpful 
helpful 
helpful 
establish a healthy 
relationship with our 
healthcare providers and 
that we have to do our part 
in taking care of ourselves 
outside of the doctor's 
office in order to stay 
.. healthy was helpfillto1ne. 
Gathering 6, with the 
Very helpful 
Somewhat 
A little 
Not at all 
purpose of learning about 
helpful 
helpful 
helpful 
how to speak and act for 
ourselves and our families 
for better health including 
understanding our personal 
communication sty le and 
discovering ways to find 
our voice and communicate 
our needs directly, openly 
and honestly with others 
was helpful to me. 
5 

Gathering 7 with the 
· Very helpful 
purpose of planning for the 
future and celebrating our 
. program was helpful to me. 
Somewhat 
helpful 
. A little 
helpful 
Not at all 
helpful 
at end of all surveys: Aho. We really appreciate your participation with this survey. The 
information you shared will help us to make this program successful. I would like for you to 
know that the information you shared will be kept confidential and your name will not be on this 
survey. We thank you very much for sharing with us and look forward to seeing you at the first 
gathering. 
6 

SF•12Health Survey 
. 
. ... 
Thi,;;surv~y·ask.sfqriye>!Jr0i~ws, aboqt yourile.alth.\This.irilorma\ion \Vi11··~elp k99p'trac~ of~ow·.·you.fe<tl 'and. ho;v. 
well yqqar~').bletq dq y0ur usuaLac\i\liti1's· .An~'ll(er eaf1Ji9ues~ionby ch()osing jus.f.one,answer• If you.are 
trnsure•hPw•fo answer a question, please;give.tffe P:est answer yi;lq can. 
· ·· 
· · 
· · 
· 
1. In general, would you say your health is• 
D• Excellent 
D' Very good 
Do Good 
D, Fair 
D; Poor 
The following questions are about activities you might do during a typical day. Does your health now 
limit you in these activities? If so, how much? 
activities: su<;h as pushing ~' vHccuum clean&r, 
ci1iid, vvalkin9 f<;r exen::i~:;e, or round dancing/push 
3. Climbing several flights of stairs. 
YES, 
limited 
a little 
c@i~:-;Y<:'>' -
Do 
During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of your physical health? 
NO 
'h .· l>ilflfci!Tlplished 11.'is's tHan ycii.lwciu1ctlf[~. 
5. Were limited in the kind of work or other activities. 
D• 
During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of any emotional problems (such as feeling depressed or anxious)? 
YES 
NO 
6. ii.h\;oni~f1~11.id•J.isis\!1~n>.yiJ1•(vidu1a.1ike .. ".···· · 
7. Did work or activities less carefully than usual. 
D. 
D' 
8. During the past 4 weeks, how much did pain interfere with your normal work (including work outside 
the home and housework)? 
D• Not at all 
D, A little bit 
Do Moderately 
D< Quite a bit 
D; Extremely 
These questions are about how you have been feeling during the past 4 weeks. 
For each question, please give the one answer that comes closest to the way you have been feeling. 
How much of the time during the past 4 weeks ... 
$. tiav1¥%1l re1i?P:a1m'8. · peaierui? 
All of 
the 
time 
10. Did you have a lot of energy? 
01 
11. !'ia~~;'ci1)'1~11 do<ii:r1'h<iari~Ci'~rfil•·•······· 
b:lue? 
· 
Most 
of the 
time 
Some 
of the 
A little 
of the 
12. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? 
None 
of the 
D• All of the time 
D' Most of the time 
Do Some of the time 
D• A little of the time 
D; None of the time 

"PFA21 
PROMIS® Item Bank v2.0 -Physical Function - Short Form Sb 
Physical Function - Short Form Sb 
Please respond to each question or statement by marking one box per row. 
Without 
With a 
With 
any 
little 
some 
difficulty 
difficulty 
difficulty 
·1i Are you able to .do cha.res such as 
··.·. vac11umlng.or yard.work? ......•.•.. : .....•.....•..... 
D 
CJ 
D 
5 
4 
3 
I }\re ·you abletQ goup a11.d:<fown s\~irsata 
.. · 
I 
@rmajpac~?;·····';········ .. ·•\•······2·····•\~.'••'··•:;,; 
D 
4 
Are you ilble to. gb fora walkofat least 
15 minutes? .............................. : ... ·.····"'··': •.. 
i, _ _." 
' .. : .. :.·-,::'-,:--:".,:, ·:· ,:_ 
,,.:\,, ,, 
_.,--,,;.:<~" 
I ~eyou ah!etonm.errauds and shog?. 
I 
I· 
·. 
·. 
. 
_,,·-~:-
. 
·-· 
I D9es yol.11" health uo;w limit you.i11 doing 
I two hourswf physical labor? ....... : ..........•. :,. 
I 
··1 Doesyow health, now. limityoh indoing 
• moderatework arou:n~ the ho}lse like 
L vacll;1lming, sweeping floors <Jr'.Carrying. in 
I !5fBc~ries? '····' .. , ...... :: .. r. ....... ',:E. :~5it·' '·., '°··\· 
I . ... 
. 
. 
. .... 
.. 
I J 
Doe.s yow health1:()~ limit you in lifting 
]or <;fWY!nggroceq~s.,,., ........ ., .•................. 
. l 
·o 
D 
5 
3 
D 
D 
·.5 
4 
Not at all 
Very little 
Somewhat 
D 
·"-<L:J•··•• 
D 
5 
4 
3 
D 
D 
D 
4 
i ])~~~yoJthealthno*' timit yoJ(~ <loin¥ 
j e>A• 
i heavy work aroui:d the house lik~ 
··•··••·• 
...... /•ii~~:~~~~;~~' .. ~~'li~ti~g..~~-~~~;~ ........ . 
5 
29November2016 
With 
much 
difficulty 
·o 
2 
D 
-.2. 
Quite a 
lot 
D 
D 
2 
© 2008-2016 PROMIS Health Organization and PROMIS Cooperative Group 
Pagelofl 
Unable to 
do 
D 
D 
D 
. .-51' 
Cannot do 
D 
D 
D 

PROMIS Item Bank vl.O - Self-Efficacy for Managing Symptoms- Short Form 8a 
Self-Efficacy for Managing Symptoms - Short Form Sa 
Please respond to each question or statement by marking one box per row. 
CURRENT level of confidence ... 
r 
!,
1 I can manag· e 111y S'"llptoms during my . 
! SEMsX010 
-
.Ji 
-
-
-
-
I daily activities ............. , . ., ......... ; ................ .. 
1 ''"""4 i lean keep mysymptoms from interfering 
I with relationships with frie.n.ds and familY, 
i lean 111<ffiage my syrtiptoms in a pnblic 
i SEMSX009 1- pta:ce .. ~-:::~:<-.:;:}:: .. ~-.::; .. ,;;-:<::·: ..... -.......... ~-:-;·_.-.--.. .-.-; ... _.-.. . 
i SEMSX017 
! i I can work with my docfor to manage my 
I 
-
-
- -
-
! symptoms .... , ..... , ........ ;., ....................... ., .... : .. . 
! 
I 1 can keep my .symptoms from interfering 
\ with my personal care 
! 
lam 
not at all 
confident 
D 
D 
D 
D 
D 
'""'°°' . ll canrt1ana~e mys)'Piptoms whenXainat 
D 
/ home ... : ......................................... : ....•.. : .... . 
' 
\I cankeep my symptoll}$ rrominterfering 
D 
! SEMSX015 
-
-
-
-
i with the work I need to.do ......................... .. 
i ''""°'' i lean findthe informationJ11eed to 
D 
L ................... J manage my.symptoms;., .•.... : .. :.;:: ........ :• ........ . 
Last Updated: 5 August 2016 
Jam 
lam 
a little 
somewhat 
confident 
confident 
D 
D 
2 
3 
D 
D 
2 
3 
D 
D 
2 
D 
D 
2 
D 
D 
2 
3 
D 
D 
2 
3 • 
D 
D 
2 
D 
D 
.2 
3 
lam 
quite 
confident 
D 
4 
D 
4 
D 
4 
D 
4 
D 
4 
D 
4 
D 
4 
D 
4 
© 2010-2016 PROM IS Health Organization and PROMIS Cooperative Group 
Page 1 of 1 
lam 
very 
confident 
D 
5 
D 
5 
D 
5 
D 
s-·-
D 
5 
D 
5 
D 
5 
D 
5 

Riiii·rstll B\e,ElmB ~·11·ssmrra,=1£1i1R:e~~c·~> ·-
-
:: •. 
:· 
~·:~l:\H"i~~9} 
· 
: _ _:. 
~ · 
Over the last 2 weeks, how often have you been bothered 
by any of the following problems? 
(Use "v" to indicate your answer) 
1. Little interest or pleasure in doing things 
2. Feeling down, depressed, or hopeless 
3. Trouble falling or staying asleep, or sleeping too much 
4. Feeling tired or having little energy 
5. Poor appetite or overeating 
6. Feeling bad about yourself -
or that you are a failure or 
have let yourself or your family down 
7. Trouble concentrating on things, such as reading the 
newspaper or watching television 
8. Moving or speaking so slowly that other people could have 
noticed? Or the opposite -
being so fidgety or restless 
that you have been moving around a lot more than usual 
9. Thoughts that you would be better off dead or of hurting 
yourself in some way 
FOR OFFICE CODING 
Not at all 
0 
0 
0 
0 
0 
0 
0 
0 
0 
_o_ + 
Several 
days 
+ 
More 
than half 
the days 
2 
2 
2 
2 
2 
2 
2 
2 
2 
+ 
=Total Score: 
Nearly 
every 
day 
3 
:i 
3 
3 
3 
3 
3 
3 
3 
If you checked off~ problems, how difficult have these problems made it for you to do your 
work, take care of things at home, or get along with other people? 
Not difficult 
al all 
D 
Somewhat 
difficult 
D 
Very 
difficult 
D 
Extremely 
difficult 
D 
Developed by Ors. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from 
Pfizer Inc. No permission required to reproduce, translate, display or distribute. 

-
--- ----
-------------~---
Please respond to each statement by making one box per row. 
Related to my ongoing illness( es), 
I usually don't do 
I usually do this a 
I usually do this a 
I usually do this a 
this at all 
little bit 
medium amount 
lot 
I say to myself "this isn't 
real." 
I refuse to believe that it 
has happened 
I pretend that it hasn't 
really happened. 
I act as though it hasn't 
even happened. 
I get used to the idea that it 
happened. 
l accept that this has 
happened and that it can't 
be changed. 
I accept the reality of the 
fact that it happened. 
I learn to live with it. 
Key reference: 
Carver, C. 5., Scheier, M. F., & Weintraub, J. K. (1989). Assessing coping strategies: A 
theoretically based approach. Journal of Personality and Social Psychology, 56, 267-283. 
assets/psvchol ogy/ d.ocu ments/facu ltv/ p89 CQP E. pdf 

13-iten'l Short Forni Patient Activation Measure (PAM) by Insignia Health(l) 
(Item responses scored by proprietary scale available following licensing) 
1. When all is said and done, I am the person who is responsible for managing my health 
condition 
2. Taking an active role in my own health care is the most important factor in 
determining my health and ability to function 
3. I am confident that I can take actions that will help prevent or minimize some 
symptoms or probleins associated vvith my health condition 
4. I know what each of my prescribed medications do 
5. I am confident that I can tell when I need to go get medical care and when I can handle 
a health problem myself 
6. I am confident I can tell my health care provider concerns I have even when he or she 
does not ask 
7. I am confident that I can follow through on medical treatments I need to do at home 
8. I understand the nature and causes of my health condition(s) 
9. I know the different medical treatment options available for my health condition 
10. I have been able to maintain the lifestyle changes for my health that I have made 
11. I know how to prevent further problems with my health condition 
12. I am confident I can figure out solutions when new situations or problems arise with 
my health condition 
13. I am confident that I can maintain lifestyle changes like diet and exercise even during 
times of stress 
1. 
Hibbard J, Mahoney E, Stockard J, Tusler M. Development and testing of a 
short form of the patient activation measure. Health Services Research 
2005;40(6):1918-1930. 

-- ---.. ------
PRO MIS Ite1n Bank v2.0 - Emotional Support - Short Form Sa 
Emotional Support - Short Form Sa 
Please respond to each item by marking one box per row. 
Never 
Rarely 
Sometimes 
Usually 
Always 
I have someone who will listen to me 
D 
D 
D 
D 
D 
FSE31053x2 
when I need to talk .................................. 
2 
3 
4 
5 
I have someone to confide in or talk to 
D 
D 
D 
D 
D 
FSE31059x2 
about myself or my problems ................ 
2 
4 
5 
I have someone who makes me feel 
D 
D 
D 
D 
D 
SS12x 
appreciated ........... ; .................................. 
2 
3 
4 
5 
I have someone to talk with when I have 
D 
D 
D 
D 
D 
SSQ3x2 
a bad day ................................................. 
2 
4 
5 
FSE31069x2 
I have someone who understands my 
D 
D 
D 
D 
D 
problems .................................................. 
2 
3 
4 
5 
I have someone I trust to talk with about 
D 
D 
D 
D 
D 
SSE-CaPS6 
my feelings .............................................. 
2 
3 
4 
5 
FSE31066x2 
I have someone with whom to share my 
D 
D 
D 
D 
D 
most private worries and fears ................ 
2 
4 
5 
! 
I I have someone I trust to talk with about 
D 
D 
D 
D 
D 
SSQ4x2 
..... -~my problems ........................................... 
2 
4 
5 
23 June 2016 
© 2008-2016 PROMIS Health Organization and PROMIS Cooperative Group 
Page 1 of 1 

PROMIS Item Bank vl.O - Self-Efficacy for Managing Emotions - Short Form Sa 
Self-Efficacy for Managing Emotions - Short Form Sa 
Please respond to each question or statement by marking one box per row. 
CURRENT level of confidence ... 
r .. 0-··--···----·,---··1 
l '""'""iJJ can hartdle negativefeelings .................. . 
' 
<:r 
i 
------- -- ! 
i "'"'"°'' i I can fludways:tomanage stress ......... , ....... . 
1-
_,- i-
-
------------- -- >:: --_> __ : 
------
! 
! 
--_-'(--
-- -
__ ,-
-
--
-----_':.:: 
I ""'""' i JG'ilnliandle upsettir;gs}tuations ..... ; ........ ;,, 
I 
"I"- - ----
-
-
-
._.-.-
_.___ 
-
---
1 
' 
-
- -
! \ ""'~''' I Lean avoid feeling discouraged .. , ......... : .. : .. 
I .·· . jlr ~an keep emotionafdistress from 
I ""'""' f,mterlering.wifu things~ wantto cl.o ..... , ...... 
f··""'"''° !fcan'boUl;lce 1Ja2kfrom'<lis~~poi11tmeut.o<. 
! --
- i 
--
- -----
_----_._-, 
--
-
-_ 
\, ''"fMoo~ \ J can refaxinybodytp reduce my an:l(.iety. 
1,-
_- __ --:--c-; 
-
_; 
_ 
_-_ - -_: 
-- -,-
-
- .- ----' __ 
-
---
-': 
i 
----1 
-----
! 
i 
i """''" Frqanliandle the stressofgoingf'or 
· 
! treatmentofmymedical conditions ... , ... • ... 
Last Updated: 5 August 2016 
I am not at 
all 
confident 
D 
D 
L. 
D 
D 
1 
·•o 
D 
I 
D 
1 
I am a 
little 
confident 
D 
2 
·D 
2 
D 
2 
D 
2 
D 
0 
2 
D 
2. 
lam 
somewhat 
confident 
[J 
3 
D 
3 
D 
D 
3. 
lam 
quite 
confident 
[] 
4 
D 
4 
D 
4 
D 
0 
4 
D 
© 2010- 2016 PROMIS Health Organization and PROMIS Cooperative Group 
Page I of 1 
lam 
very 
confident 
D 
5 
D 
5 
D·. 
5 
D 
5 
D 
5 
D 
5 
D 

Neuro-QOL Item Bank vl .0 - Positive Affect and Well-Being- Short Form 
Positive Affect and Well-Being - Short Form 
Please respond to each question or statement by marking one box per row. 
Lately ... 
;aeem lthada s.euseofwell-bei!lW······· .. •··· ... 
Never 
Rarely 
Sometimes 
Often 
D 
D 
D 
2 
3 
4 
D 
D 
0 
D 
2 
3 
4 
NOPPF!2, 
rfelt,hOjJ'efuL<;:, .... .. : ·• ..... ~-,,. · •• ·-·-· • · · · · · .. .. 
0 
D 
D 
2. 
3 
4 
. .... -..... 
0 
<PPPrn 
Mylifewas satisfying. 
D 
D 
D 
2 
':3 
4 
NQPPF20 
My Hfeha<lp1lrpose.•.):, ......... ''··'··· 
D 
D 
D 
D 
2 
3 
4 
• My
0
life had meanmg< ........ ·.·.,., .... . 
D 
NQPPF,17 
D 
D 
D 
2 
3 
4 
NQPPF22 
I felt cheerful.. . · ................................. . 
D 
D 
D 
D 
2 
3 
4 
NOPPF19 
My lj:fe was worth livJug .. : .. , ....... , , ... , , . 
D 
D 
D 
2 
3 
4 
D 
r 
.· Il1ad~iens.e of balance in fl1ylif'e ... . 
NOPPF07 
,Many areas of rµy lifewere interesting to 
D 
0 
D 
D 
2 
3 
4 
me.; ............................... 
·~ ............... .. 
............................. 
©2008-2013 David Cella and the PROMIS Health Organization on behalf of the National Institute for Neurological 
Disorders and Stroke (NINDS). Used with pennission. 
English 
March 6, 2014 
Page I of I 
Always 
D 
5 
D 
5 
0 
5 
D 
5 
D 
5 
D 
5 
D 
5 
D 
5 
D 
.5 

PROMIS Itetn Bank vl .0 - Self-Efficacy for Managing Social Interactions - Short Form 4a 
Self-Efficacy for Managing Social Interactions - Short Form 4a 
Please respond to each question or statement by marking one box per row. 
CURRENT level of confidence ... 
··········lr·ga1ltalkabout my health problemswri.th.•'··. 
i SE_MSS014 -},L~--~qfu_~o~ e 
·:-L . _.-.. .-•. ;;'. ·'. ... ; . -~ . -~_._-.<---: --.~-:< .... -,•/:l ~~_._.-~:'.--I2:-.:_.::_::::-~--:-~:. -;-:_. 
1:----
i·:·/i• ; irr.I.neesJ· heip;•X\ca'!;l'fmds0.we'6iie';to take 
l:-3-_i:;~~-:Q?:4'.-.:! 
: - - -----
_-
_-:::----------_-:<--:-><_-;:·--_'---:·----------:_-_-_<:_-_::--_------: 
I • · ·.·,· .> i me Jo, the doctqr'.s office ..•. : ...... : ............. :.:. 
I (can get emotionals1lpporfwhen I. ne.ed 
SEMSS013 
!--~~t~\(;_. __ ~(,\--, -·-·:~;' '•' • • •' • •' • ·-·'; •' .-_. • • •' • ,-, •; • • ·:-•-•• •_.h;_;_-, _.: • .-:;-'.~ '. :•_-~-:­
' /f c;al1 ask for help•wheh.ldon'tiittderstilnd 
L~~.:2.;,:::;:_~J-:--~-Oti{ethlni_ ·-· ... _,_. __ .----.:--_::_;_-._: .~- ;--,~->'.'.--_._;.:_. :--._-.'° '._~--. .-_::::·.~ ~.--.';- .--:-.-.- ._.: . -; ~ . -.. 
Last Updated: 5 August 2016 
lam 
not at all 
confident 
>D 
D 
1. 
lam 
a little 
confident 
D 
2 
lam 
somewhat 
confident 
D 
3 
lam 
quite 
confident 
.. 'D 
4 
D 
A 
D 
4 
© 2010 - 2016 PROM IS Health Organization and PROMIS Cooperative Group 
Page 1 oft 
lam 
very 
confident 
•o 
5 
D 
5 
D 
5 
D 
5 

-
---· -------------------------
PROMIS Ite1n Bank vl .0 -Satisfaction \Vith Participation in Social Roles - Short Form Sa 
Satisfaction with Participation in Social Roles - Short Form Sa 
Please respond to each question or statement by marking one box per row. 
ln the past 7 days ... 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
SRPSAT07 
I am satisfied with how ll1uch work I can 
D 
D 
D 
D 
D 
do {includeworkath01ne) ... , ..................... 
2 
3 
4 
5 
SRPSAT24 
I.am satisfied with my ability to work 
D 
D 
D 
D 
D 
' (include Workathome). "-·· ............ " .. 
2 
.3 
4. 
5 
I .am satisfied with myability to do 
D 
D 
D 
D 
D 
SRPSAT47 
regular personal and household 
2 
3 
4 
5 
responsibilities .......... , ................................ 
SRPSAT49 
I am satisfied withmy ability to perform 
D 
D 
D 
D 
D 
my daily routines ................. ,_._ ..................... 
2 
4 
5 
SftPSAT50 i I am satisfied with my .ability to meet the 
D 
D 
D 
D 
D 
needs of those who>depend on me ......... 
2 
3 
4 
5 
SRPSAT39 
I am satisfied with rny ability to do, 
D 
D 
D 
D 
D 
househ_old chores/tasks ...................... 
2 
3 
4 
5 
SRPSAT06 
! I am satisfied with my ability to do things 
D 
D 
D 
D 
D 
. for my family .................................. 
2 
3 
4 
SRPSAT38 
I am satisfied with the amount of time I 
D 
D 
D 
D 
D 
spend perfon11ing my daily routines .... ,_ .. 
2. 
3 
4 
5 
6 June 2016 
© 2008-2016 PRO MIS Health Organization and PROMIS Cooperalive Group 
Page 1 of I 

Baa nnilah program qualitative interview questions 
Hello. I am Alma McCormick. Thank you for agreeing to talk about your experiences 
vvith the Baa nnilah program. We plan to use the information shared in the interviews to 
improve the program for the future. We hope you will share with us your true feelings, 
for there are no right or wrong answers to these questions. We will be tape-recording 
our conversation so that we make sure to receive everything that you have to share. 
Participation in this interview is voluntary and you can choose to either share your name 
or have the information you share be anonymous, meaning that your name will not 
appear anywhere. You can stop the interview at anytime or not answer any question. 
The interview will take about one hour of your time and you will be paid a $30 gift card 
to thank you for your help. Let's begin. 
• How did participating in the Baa nnilah program impact your life? 
• How did your Baa nnilah program mentor impact your life? 
o What information did you learn from your mentor? 
o How did the mentor's teaching style impact your learning? 
• What have you shared about the program with community members and others? 
o How have you shared about this program? 
(Give participant the list of gathering topics for the next set of questions.) 
• What have you changed about your self-care after participating in the Baa nnilah 
program? 
o What information/tips/techniques from the Baa nnilah program did you 
apply or are you applying to your own life? 
• If you think about how you talked with others about your health before and after 
being in Baa nnilah - how has it changed? 
• What has changed in your relationships with your family and friends since being 
in Baa nnilah? 
• What has changed in your relationship with your doctor since being in Baa 
nnilah? 
o How has the communication between you and your doctor changed? 
o How has your doctor's attitude changed since being in Baa nnilah? 
• Ask about concern and thoroughness if they don't mention these 
o How has the doctor's behavior and treatment toward you changed? 
• Which parts of the program (which gathering) were most helpful? 
• Which parts of the program (which gathering) was least helpful? 
• What would you change to make the program better for the future? 
• 
Since starting with the Baa nnilah program, what other support in addition to 
being in the program has made a difference for your health? 
• In your observation, what changes have you noticed in the community as a result 
of this program? 
• What do you see for yourself for the future? 
o What information/tips/techniques from the program will you use in the 
future? 

• What ideas do you have for the future of the Baa nnilah program in the Crow 
community? 
Aho. Thank you for your time today. You are helping us to make the Baa nnilah program 
most effective. 

-
----------------~
Facilitator measures of fidelity 
1. Recruitment: Mentor will have a "Participant Notebook" where they keep track of 
names and contact information of community members they recruited, location 
of recruitment, and date of recruitment. We will also gathering information on 
emergency contacts for each participant. We will use this notebook to track 
recruitment efforts. Note: The Participant Notebook will not be linked to the 
outcome data in order to protect confidentiality of participant information. 
2. Entry into study: The Participant Notebook will also have information on the date 
the mentor consented the participant and the date they held a meeting with the 
participant to hear their health story. 
3. Retention: 
a. Each gathering will include a mentor check list of participant attendance, 
which the mentor will transfer into the Participant Notebook, which will 
be changed to number of gatherings attended by each participant in the 
database. 
b. For gatherings missed by participants, the mentor will indicate if the 
participant provided a reason for missing the gathering 
c. Participants who drop out of the study will be contacted by project staff 
(not the mentor who is leading their gatherings) and asked for their 
reasons for drop out. 
4. Dose: Each gathering will include a mentor check list of which components of the 
gathering they facilitated and the length of the gathering in minutes. An example 
is included in the materials. The evaluation will consist of the number of manual-
based intervention components delivered divided by the total number intended. 
The checklist also includes three questions: 
a. How comfortable were you in leading this gathering? 
Not at all comfortable to Very comfortable on a scale of 1-10 
b. How confident were you in leading this gathering? 
Not at all confident to Very confident on a scale of 1-10 
c. Please share any comments you have about leading this gathering. 

Mentor Gathering Check List 
Please complete this check list after the gathering has taken place. Please check the box to the 
right to show which activities you were able to complete during the gathering and answer the 
questions below. Return the completed check list to Alma or Lucille. Thank you! 
Date of gathering: ---------------
Length of gathering: ___ minutes 
Gathering 1: Beginning the Baa nnilah Journey Outline 
Welcoming, prayer, meal 
Story 
Mentor provides information: introduction/purpose of gathering 
Supportive partnerships activity 
Closing 
How comfortable were you in leading this gathering? Circle one number: 
Not at all comfortable 1 2 3 4 5 6 7 8 9 10 Very comfortable 
How confident were you in leading this gathering? Circle one number: 
Not at all confident 
1 2 3 4 5 6 7 8 9 10 Very confident 
Please share any comments you have about leading this gathering. 

Baa nnilah PrQgram Gatherings 
will begin in 2017 
is expanding our 
men and women 
recurring health 
ited to arthritis, 
Crnwcommun~"'1.,,<~~~.S\lli····.·n .··· 
~~~.been living 
with chronic hea,~•r1w"t· c~~k ' ·'••are doing 
• 
~ 
IL 
\/ i:' 
1 '1,'i ~j 
w~ll . with their self-c~. 1 
.l!l~Pl~irr'!•u • as ment~rs, 
will m turn encourage jlfitie~sl•who are facmg 
similar medical challenges. Baa nnilah mentors 
provide real-life experience, knowledge and 
cultural strength for our Crow brothers and 
sisters with on-going health concerns that may 
not be available in most medical services. 
Messengers for Health will work to keep the 
program going long-term to help inspire a 
healthier Crow People. 
women w 
concerns and .con 
rarticipants will atteriCI 
• .. . 
include a free meal. Famify""•·tti;ifub!\ 
'dhli;"'' 
welcomed to be involved and atte'n 
gatherings. 
• Gain knowledge and. tools for healthy living 
and self-care to improve your quality of life. 
• learn from mentors and other program 
members. 
• Share and apply Crow cultural stren 
address ongoing health co no 
• learn about 
nutrition 
emotional 
heal 
through ha 
• Gain 

Journey through the Baa nnilah Program 
Our 10 mentors will each recruit 20 participants. Eligible participants have an ongoing illness and are 25 
and older. Participants sign forms & identify family members and friends who want to be in a group 
together. By August 15, 2017. 
1~ 
Family members and friends who want to be together are randomly assigned to Fall (Nov 2017-Feb 2018) or Spring 
(April-July 2018) groups. There will be about 10 participants per group and 10 groups each in Fall and Spring. 
~~ 
Fall and Spring group participants come to orientation and fill out health surveys in local communities. 
10 Fall groups attend 7 Baa nnilah 
gatherings in local communities 
October 2017 
Nov 2017-
Feb 2018 
10 Spring groups stay in contact 
Fall and Spring group participants fill out health surveys in local communities. March 2018 
10 Fall groups stay in contact 
April-July 
2018 
10 Spring groups attend 7 Baa nnilah 
gatherings in local communities 
Fall and Spring group participants fill out health surveys in local communities. August 2018 
Fall and Spring group participants fill out health surveys in local communities. December 2018 

Baa nnilah information 
~ 
This program is for Crow men and women who 
have an ongoing illness. 
't 
It is a partnership with MSU-Bozeman. 
t~ 
There will be 7 gatherings in local communities 
- everyone will attend all 7 gatherings. 
t; 
Local mentors will lead the program. 
t¢. 
You will gain knowledge and tools for improving 
your health. 
t_ 
You will learn from other members and use 
cultural strengths to address ongoing health 
concerns. 
t:c.. 
There will be hands-on activities to learn about 
and apply physical activity, nutrition, and 
emotional health information. 
teo 
Members will support and help each other to 
apply what is learned to your every day life. 
tee. 
Family members are welcomed to be involved. 
t'". 
Meals will be served. 
ts. 
Participants will receive a $10 gas voucher for 
each gathering to help with transportation. 
Program staff 
Alma McCormick: 665-5492 
Lucille Other Medicine: 679-1644 
Gathering Topics 
1. 
Beginning the Baa nnilah journey 
2. 
Self-care with an ongoing illness 
3. 
Daasachchuchik (Strong heart): Overcoming 
trauma and building resilience 
4. 
Healthy food and physical activity 
5. 
Positive healthcare experiences 
6. 
Healthy communication and overcoming challenges 
7. 
Graduation, honoring, and next steps 
Mentors 
Hardin 
't 
Laura He Does It: 696-3777 
t, 
Michael Bear Claw: 696-3777 
Lodge Grass 
t, 
Beldine Crooked Arm Pease: 620-1339 
't 
Anthony Pisano: 638-1788 
Crow Agency 
t_ 
Pam Garza: 679-1027 
t 
William Falls Down: 665-7173 
t 
Lois Rides Horse: 620-1478 
Pryor 
't. 
Sampson DeCrane: 281-1014 
Wyo la 
t. 
Valencia Crooked Arm: 679-4131 
~-
Tye Backbone: 343-2006 

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1
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I

Baa nnilah information 
•: This program is for Crow men and women who have an ongoing illness. 
•: 
It is a partnership with MSU-Bozeman. 
•. There will be 7 gatherings in local communities - everyone will attend all 
7 gatherings. 
•-
Local mentors will lead the program. 
•. You will gain knowledge and tools for improving your health. 
~ You will learn from other members and use cultural strengths to address 
ongoing health concerns. 
•-
There will be hands-on activities to learn about and apply physical 
activity, nutrition, and emotional health information. 
•· Members will support and help each other to apply what is learned to 
your every day life. 
•: Family members are welcomed to be involved. 
•-
Meals will be served. 
t. Participants will receive a $10 gas voucher for each gathering to help with 
transportation. 
Program staff 
Alma McCormick: 665-5492 
Lucille Other Medicine: 679-1644 
Gathering Topics 
1. 
Beginning the Baa nnilah journey 
2. 
Self-care with an ongoing illness 
3. 
Daasachchuchik (Strong heart): Overcoming trauma and building 
resilience 
4. 
Healthy food and physical activity 
5. 
Positive healthcare experiences 
6. 
Healthy communication and overcoming challenges 
7. 
Graduation, honoring, and next steps 
Mentors 
Hardin 
••. Laura He Does It: 696-3777 
•· Michael Bear Claw: 696-3777 
Lodge Grass 
•: Beldine Crooked Arm Pease: 620-1339 
•• Anthony Pisano: 638-1788 
Crow Agency 
•-
Pam Garza: 679-1027 
••. William Falls Down: 665-7173 
•• Lois Rides Horse: 620-1478 
Pryor 
•. 
Sampson DeCrane: 281-1014 
Wyola 
•· Valencia Crooked Arm: 679-4131 
to. 
Tye Backbone: 343-2006 

i 
Subject Consent Form for Participation in Human Research at 
Montana State University 
Would you like to participate in the Messengers for Health 
Baa nnilah project? 
You are being asked to participate in a research study called the Baa nnilah project. Why 
am I being asked to participate in the Baa nnilah project? 
~, This project is being done to teach Crow men and women about ongoing health concerns. 
The project will give you the opportunity to discuss your experiences and knowledge 
about ongoing health concerns. 
ft 
The goal of the project is to increase the amount of information that Crow men and 
women have about ongoing health concerns and to increase the number of men and women 
who take steps to keep themselves healthy. This could mean improving the health and 
wellness of Crow families. Community members who have an ongoing illness and who are 25 
years old and older are welcome to participate. 
What will I be asked to do? How much time will it take? 
~· Participation is voluntary. If you choose to participate in the project, you will: 
o Come to an orientation meeting for the program. The meeting will last 2-3 hours, 
held in a community on the reservation (Wyola, Pryor, Lodge Grass, Crow Agency) 
or in Hardin and be led by project staff members including Alma McCormick and 
Lucille Other Medicine. During the meeting, we will have a meal, share information 
about the program, take a survey that asks questions about ongoing health 
concerns, and perform 3 exercises including walking for 6 minutes, standing up 
from a chair and walking 10 feet and walking back to the chair to sit, and standing 
for balance. These exercises will be used to develop an exercise program for you. 
For the survey, a member of the Baa nnilah team will read the survey questions to 
you and you will enter your answers on a computer privately so that no one will see 
your answers. You will come to another group meeting where you will take the same 
survey and complete the same exercises 4 times over the next 18 months. 
o Fill out a form that lists your ongoing health concerns. 
o Attend 7 gatherings with about 10 other people where you will learn about ongoing 
health concerns. These gatherings will take place in local communities (Wyola, 
Pryor, Lodge Grass, Crow Agency, Hardin) and be led by a community mentor. Each 
of the 7 gatherings will last for 3 hours and include a meal and hands-on activities. 

Project staff members such as Alma McCormick and Lucille Other Medicine may 
also attend the gatherings. 
o 20 participants will also be asked to complete an hour-long interview with Alma 
McCormick or another staff member after the gatherings are completed. The 
interview will help us to make the Bcia nnilah program better for the future. 
Do I have to take the survey or do the exercises? 
'!:. No. You do not have to take the survey or do the exercises. Participation is voluntary and 
you can choose to not answer any questions you do not want to answer and/or you can stop 
anytime. There will be no penalty if you decide not to take the survey or do the exercises. 
How did you get my name for this survey? 
"~ You expressed interest in participating in the Bcia nnilah project. You may have met with a 
project mentor or staff member in the community. 
Are there any risks involved with taking part in the project? Will I feel uncomfortable? 
It, Taking part in the project should not put you at risk for physical harm. You may feel 
uncomfortable answering certain questions on the survey. You can perform the 3 
exercises as you feel comfortable. You will never be required to answer any questions 
that make you feel uncomfortable or do any exercises that you do not want to do. 
I!:. During one of the gatherings, there will be a discussion of grief, loss, resilience, and 
healing. You will be provided with a list of resources available in the local communities for 
you to access if you desire. 
I!: 
In the event your participation in this research supported by the National Institutes of 
Health results in injury to you, medical treatment consisting of a referral to Indian 
Health Services or Bighorn Valley Health Center will be available. If it is an emergency, a 
project mentor or staff member will call 911. This treatment will be at your expense. 
Further information about this treatment may be obtained by calling Alma McCormick at 
665-5492 or Suzanne Held at Montana State University at 994-6321. 
What will I get out of taking part in the project? Will I get paid? 
'!:,. You will be provided with a $40.00 gas card each time you come to the meeting where you 
will complete the survey and exercises. This is to thank you for taking your time to do 
these things. You will also help us learn about ongoing health concerns among women and 
men in the Crow community. This information will help us learn if our Bcia nnilah program is 
helping people and how to make it better for others. 
I!: 
At each of the 7 gatherings, you will also receive a meal, incentives that encourage 
healthy living, and a $10 gas card to help with transportation to the gatherings. 

Is there any cost for me to participate in the Baa nnilah program? 
'"-
No, there is no cost for you to participate in the program. 
Will people know that I took part in the project? 
't To ensure confidentiality, you will be entering your answers to the survey into a computer 
tablet. The tablet does not have your name included. The information from the computer 
tablets will be transferred securely and stored on computers that have a password that 
only people working on this project can have access to. The mentors and project staff 
who will be giving you the survey have signed a form agreeing not to share any 
information. 
• 
This project is a clinical trial. A description of the clinical trial will be available 
on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include 
information that can identify you. At most, the Web site will include a summary of the 
results. You can search the Web site at any time. 
Who is paying for this project? 
t. The National Institutes of Health is paying for this project. 
Why do you have me signing this form? 
~.. This type of form is used any time people gather information for a research project. It is 
done to make sure that you understand any risks of taking the survey and completing the 
exercises and to give you people to contact in case you have any questions about the Baa 
nnilah project. 
What if I have any questions about the project or my participation? 
't If you ever have any questions about this project, please feel free to contact the project 
coordinator, Alma McCormick at 665-5492 or Suzanne Held at Montana State University 
at 994-6321. 
What if I have any questions about my rights regarding this project? 
't If you ever have any questions about your rights, you can contact Mark Quinn, the Chair 
of the Human Subjects Committee at Montana State University. His number is (406) 
994-5721. 

If you are interested in being a part of the Baa nnilah project, please read the following 
agreement statement and sign your name below the statement. 
Agreement statement: 
By signing this consent form, I agree to participate in the Baa nnilah project. I 
have read the above information and understand the discomforts, inconvenience, 
and risk of this study. I, 
(name of participant) agree to 
be a part of the Baa nnilah project. I understand that I may later refuse to 
participate, and that I may withdraw from the project at any time. I have 
received a copy of this consent form for my own records. 
Participant signature ____________ Date ____ _ 
Mentor Signature ___________ Date ____ _ 

-
- - --- ---------
CROW TRIBE EXECUTIVE BRANCH 
Bocheeitche Avenue 
P.Cl Box 159 
Alvin Not Afraid. Ir. 
Cl-!A!RMA~ 
Crov..- Agency {Booxllwuaoshe~), Monrono 59D22 
Phone: ( 406) 638-3732/638-3786 
Fox: (406) 638-7301 
Carlson Goes ;\head 
V!CE-Cl!AlRMAN 
lune 13, 2017 
Mark Quinn, Chairman for MSU-IRB 
P.O .. Box 173610 
Bo2eman, MT 5971 7 
Dear Mr. Quinn. 
Rndolpfl Old Cro~ 
Sf:CRETt\RY 
Shawn Bacl{bong 
VJC!:-SECRETARY 
On behalf ofthe Crow Tribe, I am honored and pleased to support Messengers for Health (MFH) in their 
efforts to improve the health and wellness of the Crow people. MFH cmder the leadership of Crow tribal 
member, Alma McCc)nmiek, a long-standing community-based project on the Crow Indian reservation 
!hat provides effective culmrally appropriate health outreach 
among the Crow people. 
MFH began as a research project in 200 I funded by the American Cancer Society and worked in 
partnership with !he Mmrtana Stale University (MSU) Bozeman in Bozeman, Montana and the Crow 
Nation. In 2010, MFH became a 501 (c) (3) American indian nonprofit organization in order to rontinuc 
their outreach services and address other health needs in the C:row co1n1nunity, 
At this time, MFH is again working collaboratively with MSU·lfozeman to develop and implement a 
culturally appropriate intervention kno\vn as~ the "Baannilah" Prognun to in1prove the self-care 
n1a.nagc1:11ent of Crow people i:vith chronic illnesses. Diabetes is prevalent in our con1rnunity and rnany 
people are in need of suppmt services so they are able to helter themselves, TI1e Baan11ilah intervention 
\viH utilize (:.row cultural strengths and values co1nhined \.Vith ihc 
of research to 
a 
mcntorship intervention to encourage and support individuals with chronic health conditions toward 
hnproved self-can~ and "vetJ .. bcing. 
The Cro\\i Tribe tlilly supports tvIFll and their efforts and goals to ifftprovc chronic illness manage1nent 
·arnongst the Cro\V people. If you have any questions, please call (406) 638-··2059. 
Sincerely. 
\/ice-Chairrnan, C.ro\v Tribe 
The Great Apscmlooke Nation: "Teepee Capital of the World" 

 
 
 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and followed 
throughout the life of the project with yearly renewals. Protocols approved in the Exempt 
category do not require yearly renewals. All study documents are subject to review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: The Báa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321; Suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
□ Research protocol 
x Consent form 
□ Recruitment materials 
□ Survey instrument, interview questions 
□ Research personnel 
□ Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of where within 
the study documents (e.g. Research protocol, survey instrument, etc.) the changes are 
reflected (e.g., section, question #, etc.) 
 
In response to a recent National Institutes of Health policy update regarding Certificates of 
Confidentiality, we have a prepared an Addendum to our Informed Consent for our IRB approval for 
“The Báa nnilah project,” approval SH082017. The policy update provides all NIH funded human subjects 
research with a Certificate of Confidentiality, which provides additional privacy protections for data 
collected during the Baa nnilah project. More information regarding the policy update is available within 
NOT-OD-17-109 and at https://humansubjects.nih.gov/coc/index. 
We are seeking your approval to add the attached document to our informed consent form. We would 
like to provide the information to participants who were already consented and attended the data 
collection meetings (10 people) and add it to our form for those who have not received consent or who 
have not attended the data collection meetings (about 190 people). 
 
6. Have these requested changes been initiated? 

□  No 
x  Yes 
 
We had a data collection meeting last night – October 24, 2017 and we handed out the 
additional information below to 5 participants.  
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research procedure or 
deviating from IRB approved documents unless it is in the best interest of or for the safety 
of study participants. 
 
This will provide further protections to participants of their confidentiality. 
 
 

Additional Form for Informed Consent:  
Certificate of Confidentiality Covering Participation in Human Research at 
Montana State University 
 
What is a Certificate of Confidentiality? 
 A Certificate of Confidentiality helps us protect your privacy. 
 
What does the Certificate of Confidentiality do? 
 It lets us legally refuse to release information you share through the Báa nnilah 
program that may identify you in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. 
  
Are there limits to what a Certificate of Confidentiality can do? 
 It cannot be used to resist a demand for information from personnel from the 
agency that gives us funding, which is the National Institues of Health, for auditing 
or program evaluation purposes.  
 We must share information you share about reports of child abuse and neglect, or 
active, specific threats of harm to yourself or others. 
 
What if I want to share my information? 
 The Certificate of Confidentiality does not prevent you from voluntarily releasing 
information about yourself or your involvement in this research.    If an insurer, 
medical care provider, or other person obtains your written consent to receive 
research information, then the researchers will not use the Certificate to withhold 
that information. 
 
 

 
 
 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and followed 
throughout the life of the project with yearly renewals. Protocols approved in the Exempt 
category do not require yearly renewals. All study documents are subject to review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: The baa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321/suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
x Research protocol 
□ Consent form 
□ Recruitment materials 
x Survey instrument, interview questions 
□ Research personnel 
□ Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of where within 
the study documents (e.g. Research protocol, survey instrument, etc.) the changes are 
reflected (e.g., section, question #, etc.) 
 
We would like to make amendments to our IRB application that was approved last fall. In the 
application, we have three different groups of people from whom data will be gathered.  
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
 
1. Participants of intervention: all participants. There are two changes – one to the timeline and one to 
add a data collection element.  
 

For this group, the actual timeline for group data collection is different from what was proposed in the 
application. The application has data gathering events occurring in March 2018, August 2018, and 
December 2018 for the intervention participants. The actual months will be April/May 2018, 
October/November 2018, and April 2019. 
We are proposing to add a data collection element for the intervention participants. All participants 
attend 7 gatherings as a part of the intervention. The intervention is led by facilitators who are members 
of the Crow community. Project staff members will send postcard reminders the week before each 
gathering and text or phone call reminders to participants on the day of each of the 7 gatherings. Project 
staff will save participant phone numbers only by participant ID number versus by name. Any responses 
to the text or phone reminders will be archived, again only by participant ID. Additionally, we would like 
to add questions to the post-intervention survey to ascertain how well each of the retention strategies 
helped participants to keep attending each of the gatherings (to improve and track participant 
retention). The questions are below and will be answered on computer tablets with the already 
approved surveys. 
Please check how much each of the following helped you to keep coming to the gatherings  
 
Not at All  
A Little 
Bit  
Somewhat  
Quite a 
Bit   
Very 
Much  
Newsletter  
 
 
 
 
 
Gifts received at gatherings  
 
 
 
 
 
Gas cards received at 
gatherings 
 
 
 
 
 
My supportive partner  
 
 
 
 
 
Information I learned at the 
gatherings 
 
 
 
 
 
My personal motivation  
 
 
 
 
 
Collecting my feathers 
(goals)  
 
 
 
 
 
Healthy meals at gatherings   
 
 
 
 
My relationship with my 
mentor 
 
 
 
 
 
My bonding with other 
participants  
 
 
 
 
 
Location of gatherings  
 
 
 
 
 
Postcard reminders  
 
 
 
 
 
Phone texts/calls from MSU 
team members 
 
 
 
 
 
Phone texts/calls from my 
mentor  
 
 
 
 
 
Other (please explain):  
 
 
 
 
 
 
 
 
 
 

Please check how much each of the following prevented you from attending the gatherings  
 
Not at All  
A Little 
Bit  
Somewhat  Quite a 
Bit 
Very 
Much  
Weather  
 
 
 
 
 
Lack of transportation  
 
 
 
 
 
My personal health  
 
 
 
 
 
Deaths in the community 
 
 
 
 
 
Death in the family 
 
 
 
 
 
Personal or family crisis  
 
 
 
 
 
Community events   
 
 
 
 
 
Work schedule  
 
 
 
 
 
Not being informed of 
gathering times and locations 
 
 
 
 
 
Changing schedule of 
gatherings  
 
 
 
 
 
Location of gatherings 
 
 
 
 
 
Family member care  
 
 
 
 
 
Atmosphere and feeling of 
gatherings 
-Please explain any gathering 
issues:  
 
 
 
 
 
 
Other (please explain):  
 
 
 
 
 
 
 
2. Participants of intervention: subgroup – no changes at this time 
3. Intervention facilitators. We are adding a data collection element.  
There are 10 intervention facilitators who are Crow community members. They are each leading 7 
gatherings/meetings in the community. We are taking a random sample of one of the 10 facilitators for 
each of the 7 gatherings to complete an additional fidelity evaluation. The data will be gathered by co-PI 
Alma McCormick, a member of the Crow Nation. The evaluation instrument is below.  
In addition, for process evaluation and fidelity tracking, we are keeping field notes of texts and phone 
call communications with the intervention facilitators. This information will provide context and a 
deeper understanding of the delivery of the intervention. An example of this information is when a 
gathering is postponed due to weather or because participants are out of town at a basketball 
tournament.  
6. Have these requested changes been initiated? 
x  No – for #1, participants of intervention 
x  Yes – for #3, intervention facilitators 
 
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research procedure or 
deviating from IRB approved documents unless it is in the best interest of or for the safety 
of study participants. 

 
The only affect is that the survey (#1 above) will take approximately 5 minutes longer for 
participants.  
 
 

 
Not 
Completed 
Partially 
Completed 
Fully 
Completed 
 
Did the Mentor add new 
components not in the 
original protocol? 
Welcoming, prayer, meal  
 
30 min  
 
 
 
Story  
 
10 min  
 
 
 
Mentor provides 
information: 
introduction/purpose of 
gathering  
 
30 min  
 
 
 
Sharing circle  
 
50 min  
 
 
 
Supportive partnerships 
activity 
 
50 min  
 
 
 
Closing 
 
10 min  
 
 
 
Mentor Responsibility (Communication with participants, bringing all necessary materials, being on-
time, etc.)   
 
 
 
 
 
Mentor Interactional Style (Ex. Speaking Crow, facilitation style, food choices, humor, empathy, etc.) 
Comments:  
Participant & Environmental Factors (Ex. Health condition, weather, deaths, presence of people not 
in the program, etc.) 
Comments 
 
 
 
 
 

 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and followed 
throughout the life of the project with yearly renewals. Protocols approved in the Exempt 
category do not require yearly renewals. All study documents are subject to review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: The baa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321/suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
x Research protocol 
□ Consent form 
□ Recruitment materials 
x Survey instrument, interview questions 
□ Research personnel 
□ Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of where 
within the study documents (e.g. Research protocol, survey instrument, etc.) the 
changes are reflected (e.g., section, question #, etc.) 
 
We would like to make amendments to our IRB application that was approved last fall. In the 
application, we have three different groups of people from whom data will be gathered.  
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
 
1. Participants of intervention: all participants. There are three additions we would like to make 
to our  data collection. 
First addition: To gather accurate data for adverse reporting, we would like to add these 
questions to the computer tablets: 
 Since you last took this survey have you been in a hospital overnight because of your 
health? 
 

Yes/no 
 Since you last took this survey have you been to the emergency room because of your 
health? 
Yes/no 
Second addition: The first question below was on our original protocol to gathering information 
on contamination from the wait-list control group. We would like to add the second and third 
question. 
1. The Messengers for Health Baa nnilah program consists of 7 gatherings in the local Crow 
communities and Hardin that are led by a community member mentor. Have you taken action 
for your health because of something you have heard or learned from a friend or family member 
who has attended the gatherings? 
Yes (if they choose this, go to the next two) 
No 
2. To what extent have you taken action from what you learned? Please choose the number that 
best describes your action taken: 
  
(not at all)  0 1 2 3 4 5 6 7 8 9 10 (A lot) 
 3. Please share what actions you have taken or changes you have made in your life because of 
what you heard or learned from a friend or family member who has attended the gatherings 
(open ended-question):  
Third addition: We are proposing to add a data collection element for the intervention 
participants. All participants attend 7 gatherings as a part of the intervention. The intervention 
is led by facilitators who are members of the Crow community. During the intervention, 
participants receive incentives related to health. We want to know if these incentives are being 
used. At the data gathering meeting, we will put the incentive on a table with a sheet of paper 
asking: “How often did you use this?” Participants who attended the intervention will put a 
check mark by the response that represents their behavior. There will also be space where they 
can write comments. Below is a table that shows the incentives and scale.  
 
Not at all 
Rarely 
Sometimes Often 
All the 
time 
Medication tracking sheet  
 
 
 
 
 
Preparing for your doctor 
visit 
 
 
 
 
 
Business card doctor visit  
 
 
 
 
 
Exercise bands 
 
 
 
 
 
Walking a good path  
 
 
 
 
 
Ground, breathe, settle 
bracelet  
 
 
 
 
 
Living a healthy life book 
 
 
 
 
 
Wrist activity tracker (fit bit) 
 
 
 
 
 
Journal  
 
 
 
 
 
 
2. Participants of intervention: subgroup – no changes at this time 

3. Intervention facilitators. – no changes at this time 
6. Have these requested changes been initiated? 
x  No  
  Yes  
 
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research procedure 
or deviating from IRB approved documents unless it is in the best interest of or for the 
safety of study participants. 
 
The only affect is that the data collection time will take approximately 5 minutes longer 
for participants.  
 

 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and followed 
throughout the life of the project with yearly renewals. Protocols approved in the Exempt 
category do not require yearly renewals. All study documents are subject to review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: Improving chronic illness management with the Apsaalooke Nation: The 
báa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321/suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
x Research protocol 
□ Consent form 
□ Recruitment materials 
x Survey instrument, interview questions 
□ Research personnel 
□ Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of where 
within the study documents (e.g. Research protocol, survey instrument, etc.) the 
changes are reflected (e.g., section, question #, etc.) 
 
We would like to make amendments to our IRB application that was approved August 2017. In 
the application, we have three different groups of people from whom data will be gathered.  
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
 
We would like to make amendments to #2 and #3. 
2. Participants of intervention: subgroup. This is a random sample of #1. The participants will 
complete an interview with project staff. The interview protocol was approved in August 2017. 
We would like to make minor modifications to some of the questions. The protocol showing 
track changes is below.  
 
3. Intervention facilitators. We would like to add an interview to be conducted by project staff 
with the intervention facilitators. The interview protocol is below.  

6. Have these requested changes been initiated? 
x  No  
  Yes  
 
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research procedure 
or deviating from IRB approved documents unless it is in the best interest of or for the 
safety of study participants. 
 
This will not affect study participants except the minor changes to the interview protocol 
for a subsample of participants (#2) and an additional interview for #3, which will take 
approximately 1 hour of their time.  
 
 

2. Participants of intervention: subgroup  
Báa nnilah program qualitative interview questions 
Hello. I am Alma McCormick. Thank you for agreeing to talk about your experiences with the 
Báa nnilah program. We plan to use the information shared in the interviews to improve the 
program for the future. We hope you will share with us your true feelings, for there are no right 
or wrong answers to these questions. We will be tape-recording our conversation so that we 
make sure to receive everything that you have to share. Participation in this interview is 
voluntary and you can choose to either share your name or have the information you share be 
anonymous, meaning that your name will not appear anywhere. You can stop the interview at 
anytime or not answer any question. The interview will take about one hour of your time and 
you will be paid a $30 gift card to thank you for your help. Let’s begin. 
• 
How did participating in the Báa nnilah program influence your life? 
o Probe if needed: Can you tell me more about that? 
o Probe if needed: Can you give me an example? 
• 
How did your Báa nnilah program mentor influence your life? 
o What did you learn from your mentor?  
o How did the mentor’s teaching style influence your learning?  
• 
What have you shared about the program with family members, community members 
and others?  
o Could you give me some of examples of how you have shared about this program? 
• 
What have you changed about your self-care after participating in the Báa nnilah 
program? 
o What information/tips/techniques from the Báa nnilah program did you apply or 
are you applying to your own life?  
• 
In what ways, if at all, has attending the Báa nnilah program changed how you share 
about your health with others? 
• 
What has changed in your relationships with your family and friends since being in the 
Báa nnilah program? 
• 
Have you seen your doctor since participating in the program? 
o If no, go to “How has this program…”  
o If yes, continue to the next question. 
• 
What has changed in your relationship with your doctor since being in the Báa nnilah 
program? 
o How has the communication between you and your doctor changed? 
o How has your doctor's attitude changed since being in Báa nnilah?  
▪ 
Probe if they don’t mention these: how about their concern and 
thoroughness?  
o How has the doctor's behavior and treatment toward you changed? 
• 
How has this program influenced your feelings of hope toward your health? 
 
Give participant the list of gathering topics for the next set of questions. 
• 
Which parts of the program (which gathering) were most helpful? 
• 
Which parts of the program (which gathering) was least helpful?  
• 
What would you change to make the program better for the future?   
o What would you add? 
o What would you get rid of? 
• 
 Since starting with the Báa nnilah program, what other support in addition to being in 
the program has made a difference for your health? 
• 
What changes have you noticed in the community as a result of this program? 
• 
What do you see for your health for the future?  
• 
What information/tips/techniques from the program will you use in the future? 

• 
What ideas do you have for the future of the Báa nnilah program in the Crow 
community? 
 
Aho. Thank you for your time today. You are helping us to make the Báa nnilah program most 
effective.  
 
 
 
 

 
3. Intervention facilitators interview protocol. 
Mentor Qualitative Interview Questions 
 
Mentor: ________________________________________________ 
Date: __________________________  Time: _________________ 
Location: _______________________________________________ 
Hello, I am Shannen Keene. Thank you for taking the time to visit with me today. We would like 
to learn about your experience as a Mentor in the Báa nnilah program. This will help us 
understand how to improve the program in the future. If it’s ok with you, I would like to record 
our conversation so I don’t miss anything that you’re sharing. Do you have any questions before 
we get started? 
1. What does being a Mentor mean to you? 
2. What experiences did you have before your involvement in the Báa nnilah program that 
helped prepare you for being a Mentor? 
3. How did you prepare for your gatherings? 
4. How did you feel leading the first gathering of your first group compared to leading the 
first gathering of your second group?  
5. Think back to a time when you were feeling the most comfortable leading your gathering. 
What made you feel that way?  
6. Think back to a time when you were feeling the most confident leading your gathering. 
What made you feel that way?  
7. How did you personalize your gatherings to make them your own?  
8. How did you know that participants understood or didn’t understand the gathering 
material? 
9. Can you tell me about the support that you received from program staff (i.e, Alma, 
Lucille, Jerik, Shauna, and the Bozeman team)? 
a. What worked well for you?  
b. What didn’t work well for you? 
10. How was it for you when program staff attended your gathering(s)? 
a. How did that support you or not support you as a Mentor? 
11. What other ways can program staff support you as a Mentor? 
12. What does successful mentorship look like to you? 
 
Aho. Thank you for your time today. You are helping us make the Báa nnilah program better. 
 
 
 

 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and followed throughout the 
life of the project with yearly renewals. Protocols approved in the Exempt category do not require yearly 
renewals. All study documents are subject to review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: Improving chronic illness management with the Apsaalooke Nation: The 
Báa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321 / suzanne@montana.edu 
Address (where you want approval letter sent): 
 
4. Requesting modification/amendment to: 
X Research protocol 
□ Consent form 
□ Recruitment materials 
□ Survey instrument, interview questions 
□ Research personnel 
□ Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of where within 
the study documents (e.g. Research protocol, survey instrument, etc.) the changes are 
reflected (e.g., section, question #, etc.). 
 
We have made slight wording changes to reflect a less stringent timeline of follow-up. 
 
6. Have these requested changes been initiated? 
□  No 
X  Yes 
 
7. How will the proposed modification(s) affect study participants? 
Study participants indicating higher levels of depression symptoms and/or more frequent 
suicidal thinking during study assessments will still be followed-up by community project 
leaders (Alma and Lucille) but with a less stringent timeline than previously indicated. 

 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and 
followed throughout the life of the project with yearly renewals. Protocols approved in 
the Exempt category do not require yearly renewals. All study documents are subject to 
review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: Improving chronic illness management with the Apsaalooke 
Nation: The báa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321/suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
   
Research protocol 
Consent form 
Recruitment materials 
x Survey instrument, interview questions 
Research personnel 
Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of 
where within the study documents (e.g. Research protocol, survey 
instrument, etc.) the changes are reflected (e.g., section, question #, etc.) 
 
We would like to make amendments to our IRB application that was approved August 
2017. In the application, we had three different groups of people from whom data was to 
be gathered.  
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
 
We would like to make amendments to #1 and to introduce a new group: 
  
4. Participants of modified intervention 
 

1. Participants of intervention: all participants. We have completed data collection 3 
times for this group, which consists of our intervention group and our wait-list control 
group completing the survey approved by the IRB. We would like approval to: 
• Make slight modifications to some of the demographic questions to ask if the 
response changed since the last survey and if it did not, to skip the question. This 
will hopefully make the survey quicker for participants to complete. 
• Remove 2 questions that should not vary over time: 1) gender and 2) year of 
birth.  
• Add a checklist of questions to assess changes in participants since they began 
the program. 
 
The original questions and changes and the checklist of questions are below.  
 
4. Participants of modified intervention. We have run both the intervention and wait-list 
control group through our 7-session intervention. We would like to explore the idea of 
an implementation study and are also committed to sustaining the intervention, as we 
shared in our grant application to NIH. We have made small changes to our intervention 
to improve the experience for participants. For example, wording changes for clarity, 
adding a new handout on whole grains, switching the order of 2 of the gatherings for 
clarity, and changing a few of the exercises in the handouts to make it easier for all 
community members to engage in the exercises. This spring, we will run 2 groups of 
approximately 10 participants through the 7 gatherings of the intervention. We will not 
have them complete the survey and exercises that the intervention and wait-list control 
group completed. We would like permission to gather information in two areas:  
 
1) Have them complete the PHQ-9 survey, which gathers information on depression. 
This will be given to each participant at the first gathering. We are having them 
complete this survey as we saw many community members with concerning scores and 
we have implemented a follow-up protocol with our intervention and wait-list control 
that we will follow with these participants.  
2) We will have participants complete the checklist of questions that is below at the 
bottom of the document at the end of their participation.  
 
6. Have these requested changes been initiated? 
x  No  
  Yes  
 
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research 
procedure or deviating from IRB approved documents unless it is in the best 
interest of or for the safety of study participants. 
 
This will not affect study participants except the minor changes to the interview 
protocol. 
 
 

1. Participants of intervention: all participants. 
 
“From” is the existing format of the question. “To” is the revised format. 
From: Which community do you live in?  
   
To: Since the last time you took this survey, have you moved to a different community?  
                No: go to next question  
                Yes: go to choices of community  
 
--------   
From: What is your current marital status?  
   
To: Since the last time you took this survey, has your marital status changed?  
                No: go to next question  
                Yes: go to choices, with this difference: combine “separated” and “divorced” into 
one choice (“separated or divorced”); delete “single, never married” and “other” 
categories  
   
----- 
From: What was the highest grade or year of school that you completed?  
   
To: Since the last time you took this survey, have you gone back to or graduated from 
school?  
                No: go to next question  
                Yes: go to choices of education with these differences:  
• 
combine: “some technical/vocational school” and “some college” into one 
choice “some education after high school”  
• 
change “high school graduate or diploma” to “high school graduate or 
GED”  
   
----- 
From: Employment status: select the statement that fits your situation best  
   
To: Since the last time you took this survey, has your employment status changed?  
                No: go to next question  
                Yes: go to choices of employment status  
   
From: Please select the number that shows how much your total household income was 
for the past 12 months [Household means all of the people who live with you and share 
income and expenses]  
   
----- 
From: About how many miles do you travel to get to the clinic where you receive your 
health care?   
To:  About how many miles do you travel to get to the clinic where you receive most 
of your health care? (one way)  
   
----- 
From: Please select the type of health insurance or health coverage that pays for your 
health care? (select all that apply)  
   
To: Since the last time you took this survey, has your health insurance or health 
coverage changed?  

                No: go to next question  
                Yes: go to question and choices of health insurance  
  
----- 
From: Please select the ongoing illness(es) that a doctor has told you that you have.  
   
To: Since the last time you took this survey, has your doctor told you that you have a 
new ongoing illness?  
                No: go to next question  
                Yes: Please type in the new ongoing illness that you now have (include an open 
box)  
 
And: Since the last time you took this survey, has your doctor told you that you that you 
no longer have an illness that you were diagnosed with before?  
No: go to next question  
Yes: Please type in the ongoing illness that you no longer have (include an open 
box)  
   
-----   
From: do you have any additional comments you would like to add? (tap the white box 
below) 
To:  Please share what you gained or learned from the program and what changes in 
your health or behavior you made because of the program? (tap the white box below) 
----- 
1. Participants of intervention: all participants. 
4. Participants of modified intervention. 
 
We will add this checklist: Check off all of the changes you have noticed since you 
started in the Báa nnilah program:  
  
Eating healthier  
Drinking more water  
Drinking less pop or other sugary drinks 
Taking more walks or exercising more  
Taking my medication more regularly  
Having better communication with my doctor  
Having better relationships with my spouse or other family members  
Feeling less alone  
Lost weight  
Shared information from the Báa nnilah program with others  
Feeling more hopeful  
Feeling less stressed  
Having more support  
Having more understanding that there are others going through what I am going 
through  
Feeling more connected to my community 
 
 
 

 
 
 
 
    Montana State University 
   Institutional Review Board 
Request for Minor Modifications/Amendments 
 
 
Instructions:  E-mail completed form and all revised and/or new study documents to: 
cherylj@montana.edu 
 
Note:  The project’s IRB-approved Research Protocol must be kept current and 
followed throughout the life of the project with yearly renewals. Protocols approved in 
the Exempt category do not require yearly renewals. All study documents are subject to 
review. 
 
1. IRB approval number: SH082017 
 
2. Project Title: Improving chronic illness management with the Apsaalooke 
Nation: The báa nnilah project 
 
3. Principal Investigator: Suzanne Held 
Contact information (phone/e-mail): 994-6321/suzanne@montana.edu 
 
4. Requesting modification/amendment to: 
 
   
Research protocol 
Consent form 
Recruitment materials 
x Survey instrument, interview questions 
Research personnel 
Other, please explain: 
 
 
 
5. Describe the modification being requested: 
Note: with each requested change, provide a detailed description of 
where within the study documents (e.g. Research protocol, survey 
instrument, etc.) the changes are reflected (e.g., section, question #, etc.) 
 
We would like to make amendments to our IRB application that was approved August 
2017. In the application, we had three different groups of people from whom data was to 
be gathered.  
1. Participants of intervention: all participants 
2. Participants of intervention: subgroup 
3. Intervention facilitators 
 
We would like to make amendments to #1: 
 
1. Participants of intervention: all participants. We have completed data collection 4 
times for this group, which consists of our intervention group and our wait-list control 

group completing the survey approved by the IRB. We have one more data collection 
event and this event is only with the wait-list control group. We would like approval to 
add this question: 
• What do you think is the best way to for us to learn what the Báa nnilah program 
did for its participants, family members, and for the Crow community as a whole?  
o If they say, “a survey” or “asking people who took part” say, “please 
explain” or “what questions would you ask?” 
 
6. Have these requested changes been initiated? 
x  No  
  Yes  
 
 
7. How will the proposed modification(s) affect study participants? 
Note: Federal regulations require IRB approval prior to changing a research 
procedure or deviating from IRB approved documents unless it is in the best 
interest of or for the safety of study participants. 
 
This will not affect study participants except the minor changes to the interview 
protocol.