Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
Phase: NA
Conditions: Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma
Sponsor: University of Minnesota

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
ANCILLARY REVIEWS 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more informa;on about these ancillary reviews.
Select yes 
or no
Does your study…
If yes…
Impact on 
IRB Review
☐ Yes 
☒ No 
Include GilleUe resources, 
staﬀ or loca;ons
Gille+e Scien/ﬁc review and Gille+e 
Research Administra/on approval is 
required.  Contact: 
research@gille+echildrens.com  
Required 
prior to 
IRB 
submission
☐ Yes 
☒ No
Involve Epic, or Fairview 
pa;ents, staﬀ, loca;ons, or 
resources?
The Fairview ancillary review will be 
assigned to your study by IRB staﬀ 
Contact: 
ll
Approval 
must be 
received 
prior to 
IRB 
commiEee
/ 
designated 
review.   
Consider 
seeking 
approval 
prior to 
IRB 
submission
.
☐ Yes 
☒ No
Include evalua;on of drugs, 
devices, biologics, tobacco, 
or dietary supplements or 
data subject to FDA 
inspec;on?
STOP – Complete the Medical 
Template Protocol (HRP-590) 
The regulatory ancillary review will 
be assigned to your study by IRB 
staﬀ 
Contact: medreg@umn.edu  
See h+ps://policy.umn.edu/
h/ d d
☐ Yes 
☒ No
Require Scien;ﬁc Review? 
Not sure? See guidance on 
next page. 
ONLY REQURED BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
 
☐ Yes 
☒ No
Relate to cancer pa;ents, 
cancer treatments, cancer 
screening/preven;on, or 
tobacco?
Complete the CPRC applica/on 
process.  
Contact: ccprc@umn.edu 
☐ Yes 
☒ No
Include the use of radia;on? 
(x-ray imaging, 
radiopharmaceu;cals, 
external beam or 
brachytherapy)
Complete the AURPC Human Use 
Applica/on and follow instruc/ons 
on the form for submission to the 
AURPC commi+ee. 
Contact: barmstro@umn.edu 
Approval 
from these 
commiEee
s must be 
received 
prior to 
IRB 
Page  of 
 
Template Revised On: 09/01/2019
1
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
☐ Yes 
☒ No
Use the Center for Magne;c 
Resonance Research (CMRR) 
as a study loca;on?
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu 
approval;  
These 
groups 
each have 
their own 
applicaMon 
process. 
☐ Yes 
☒ No
Include the use of 
recombinant or synthe;c 
nucleic acids, toxins, or 
f
?
STOP – Complete the Medical 
Template Protocol (HRP-590)
☐ Yes 
☒ No
Include the use of human 
fetal ;ssue, human embryos, 
or embryonic stem cells?
STOP – Complete the Medical 
Template Protocol (HRP-590)
☒ Yes 
☐ No
Include PHI or are you 
reques;ng a HIPAA waiver?
If yes, HIPCO will conduct a review of 
this protocol. 
Contact: privacy@umn.edu 
☐ Yes 
☒ No
Use data from the 
Informa;on Exchange (IE)?
The Informa/on Exchange ancillary 
review will be assigned to your study 
by IRB staﬀ 
Contact: ics@umn.edu 
Approval 
must be 
received 
prior to 
IRB 
approval. 
These 
groups do 
not have a 
separate 
applicaMon 
process 
but 
addiMonal 
informaMo
n from the 
study team 
may be 
required. 
☐ Yes 
☒ No
Use the Biorepository and 
Laboratory Services to collect 
;ssue for research?
STOP – Complete the Medical 
Template Protocol (HRP-590)  
The BLS ancillary review will be 
assigned to your study by IRB staﬀ. 
Contact: cdriba@umn.edu 
☐ Yes 
☒ No
Have a PI or study team 
member with a conﬂict of 
interest?
The CoI ancillary review will be 
assigned to your study by IRB staﬀ 
Contact: becca002@umn.edu 
☐ Yes 
☒ No
Need to be registered on 
clinicaltrials.gov?
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will 
be assigned to your study by IRB 
staﬀ 
k
d
☒ Yes 
☐ No
Require registra;on in 
OnCore?
If you select “No” or “I Don’t Know” 
in ETHOS, the OnCore ancillary 
review will be assigned to your study 
by IRB staﬀ 
d
Does not 
aﬀect IRB 
approval. 
Page  of 
 
Template Revised On: 09/01/2019
2
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
PROTOCOL COVER PAGE 
Protocol Title
MBI Interven;on with war-aﬀected families
Principal 
InvesMgator/Faculty 
Advisor
Name: Sarah Hoﬀman
Department: School of Nursing
Telephone Number: 512-470-7128
Email Address: hoﬀ0742@umn.edu
Student InvesMgator
N/A
ScienMﬁc 
Assessment
Clinical and Transla;onal Science Ins;tute (CTSI) pilot funding 
awards
Version Number/
Date:
Version 3/2/2022
Page  of 
 
Template Revised On: 09/01/2019
3
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
REVISION HISTORY 
Revision #
Version Date
Summary of Changes
Consent Change?
1
8/2/2021
# of sessions to 14
Yes
2
9/10/2021
Update: no changes to youth 
curriculum
No
3
9/28/2021
Oﬀering Zoom plahorm as an 
op;on in Phase 2 implementa;on. 
Adding video recording to the 
previously iden;ﬁed audio 
recording. Updated recruitment 
script to match modiﬁca;on #1.
No
4
10/04/2021
Expanding Karen recruitment 
source to targeted community 
partner referral
No
5
2/9/2022
Returning to group format for 
youth interven;on and adding post 
program interview ques;ons
Yes
6
3/2/2022
Included safety plan for if member 
of group experiences distress
No
Page  of 
 
Template Revised On: 09/01/2019
4
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Table of Contents 
1.0 
Objec;ves 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
10 
4.0 
Study Interven;on(s)/Interac;on(s) 
10 
5.0 
Procedures Involved 
12 
6.0 
Data Banking 
15 
7.0 
Sharing of Results with Par;cipants 
16 
8.0 
Study Dura;on 
16 
9.0 
Study Popula;on 
16 
11.0 Number of Par;cipants 
21 
12.0 Recruitment Methods 
21 
13.0 Withdrawal of Par;cipants 
22 
14.0 Risks to Par;cipants 
23 
15.0 Incomplete Disclosure or Decep;on 
24 
16.0 Poten;al Beneﬁts to Par;cipants 
24 
17.0 Sta;s;cal Considera;ons 
24 
18.0 Health Informa;on and Privacy Compliance 
25 
19.0 Conﬁden;ality 
28 
20.0 Provisions to Monitor the Data to Ensure the Safety of Par;cipants 
29 
21.0 Compensa;on for Research-Related Injury 
30 
22.0 Consent Process 
30 
23.0 Selng 
33 
24.0 Mul;-Site Research 
33 
25.0 Coordina;ng Center Research 
33 
26.0 Resources Available 
34 
27.0 References 
35 
Page  of 
 
Template Revised On: 09/01/2019
5
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
ABBREVIATIONS/DEFINITIONS 
●
Strengths and Diﬃcul/es Ques/onnaire (SDQ I/S) 
●
Cogni/ve and Aﬀec/ve Mindfulness Scale-Revised (CAMS-R) 
●
Karen Mental Health Screener – Brief (KMHS-B) 
●
Emo/on Regula/on Skills Ques/onnaire (ERSQ) 
●
Family Adaptability and Cohesion Scale IV (FACES) 
●
Cohen-Hoberman Inventory of Physical Symptoms (CHIPS) 
●
Post Trauma/c Stress Disorder (PTSD) 
●
Community Based Par/cipatory Research (CBPR) 
●
FMBI (Family Mindfulness Based Interven/on) 
●
CHWI (Community Health Worker Interven/onists) 
Page  of 
 
Template Revised On: 09/01/2019
6
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
1.
ObjecMves 
Purpose: Our study has two central research ques;ons: 1) Is implemen;ng a family mindfulness-
based interven;on with war-aﬀected immigrant families through community based par;cipatory 
research methods feasible?; and 2) Does the interven;on demonstrate preliminary improvements 
in the social and behavioral health of war-aﬀected caregivers and youth by addressing paUerns of 
behavior that poten;ate intergenera;onal trauma? Our objec;ve in the proposed study is to use 
Community Based Par;cipatory Research strategies to test the feasibility and acceptability of a 
mindfulness-based interven;on for Karen refugee families living post-reseUlement in the United 
States. A key focus in this phase of the pilot will be interven;on adapta;on and establishing 
ﬁdelity monitoring and quality improvement procedures through which the PI and community 
health worker interven;onists are trained and evaluated in the delivery of the interven;on. In 
future phases of the research where were are able to expand the sample size, we will submit a 
modiﬁca;on to reﬂect protocol updates. 
2.
Background 
2.1 Signiﬁcance of Research Ques;on/Purpose: Intergenera;onal trauma is a major public health 
problem impac;ng war aﬀected families. Our speciﬁc research contribu;on will test the feasibility 
of a 7-week family mindfulness-based interven;on addressing key mechanisms central to the 
health of war-aﬀected families. The signiﬁcance of our contribu;on is ;ed to the conceptual 
understanding that caregivers uniquely inﬂuence the ways in which their children process trauma, 
experience stressful events, and thrive socially, behaviorally and physically. The responses of 
youth, in turn, aﬀect the wellbeing of their parents. Lep unaddressed, intergenera;onal trauma 
will con;nue to nega;vely impact the health and life course of immigrant youth and families. 
Collec;vely, this contributes to: higher burden of unaddressed mental and physical health 
disturbances in caregivers and youth; disrup;ons in family systems and community structures 
that nega;vely impact educa;onal achievement and other indicators of youth adjustment; and 
increased exposure to familial and community violence. If a mindfulness-based interven;on 
delivered directly to war-aﬀected families in their homes can demonstrate improvements in the 
behavioral and social health eﬀects of war trauma experienced by caregivers and their youth, 
then this study has the poten;al to oﬀer a novel, eﬀec;ve approach to disrup;ng the 
genera;onal impacts of war on war-aﬀected families. We will engage mothers, fathers, and youth 
to address intergenera;onal trauma fully. We will establish plans for collabora;ve dissemina;on 
with WellShare Interna;onal in phase I of the CTRS pilot award, including academic dissemina;on 
(presenta;on and publica;on) as well as dissemina;on of results among key stakeholders and 
community members. 
2. Preliminary Data:  
IRB Study #609S95262: Paren;ng adolescent refugees post-reseUlement in Minnesota: A pilot 
interven;on targe;ng Karen family cohesion (2016-2018) 
The purpose of the study was to assess the feasibility and acceptability of engaging Karen 
refugee mothers and fathers together in a seven-week culturally oriented paren;ng 
Page  of 
 
Template Revised On: 09/01/2019
7
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
curriculum. The group paren;ng interven;on aimed to promote family cohesion and 
communica;on through parent educa;on and skill building to address adolescent behavior 
and promote adolescent sense of belonging and posi;ve iden;ty. The sample included 30-40 
Karen single parents or parent dyads with youth between the ages of 14 and 21. We 
conducted interviews with 10 adolescent-aged youth of par;cipants to elicit perspec;ves on 
parent involvement in the program. Overall the project demonstrated that Karen mothers and 
fathers could be successfully engaged in a group paren;ng interven;on. There was strong 
support for the program from caregivers and youth. Limita;ons of the interven;on included a 
focus on func;onal skill building. We have since recognized through our research that the 
inclusion of emo;on regula;on and mindfulness elements will address addi;onal factors in 
families that impact family func;oning and youth adjustment. Though evidence-based and 
implemented with a diverse sample, we feel there are stronger programs that integrate 
elements of mindfulness. Barriers to par;cipa;on included schedules and transporta;on. 
Thus we determined home based delivery is more likely to be successful in retaining 
par;cipants. 
Intergenera;onal Trauma CE Studio (2019) 
Facilitated through the University of Minnesota CTSI, a Community Engagement (CE) Studio is 
a structured guidance session that enables community experts to provide feedback on a 
par;cular health research topic. The ini;a;ve gives Minnesotans a meaningful way to 
contribute to research, while arming inves;gators with powerful insights that can inform their 
study. The study team held a CE studio that engaged 11 community experts with varying 
backgrounds, roles, and perspec;ves on refugee and migrant families and intergenera;onal 
trauma. Family based and paren;ng approaches were discussed, as was the important role of 
emo;on regula;on and mindfulness in family communica;on and problem solving.  
3. From the CE Studio, the Community Leadership Board (CLB) was formed (2019-2020). The 
CLB was comprised of members from prominent refugee serving organiza;ons who were 
themselves Karen and provided support to the Karen refugee community in their professional 
roles. The CLB met monthly through the study team’s preliminary intergenera;onal project 
and discussed aspects of the proposed interven;on, including the integra;on of emo;on 
regula;on into paren;ng-focused programs, as well as the inclusion of adolescent youth. We 
plan to reconvene the CLB, and plan that the group will play a pivotal role in guiding the 
interven;on adapta;on and implementa;on. 
4. The IRB was reviewed and discussed in a CRSC Feasibility Review. The purpose of the review 
is to provide an objec;ve review of study readiness by a panel of experts. Experienced 
research professionals from 7 research func;ons (see below) reviewed a complete protocol 
and assisted Dr. Hoﬀman in connec;ng with resources.   
•
Biosta;s;cal Design and Analysis Center (BDAC) 
•
Research Prep Group (RPG) 
•
CTSI Regulatory Specialists 
Page  of 
 
Template Revised On: 09/01/2019
8
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
•
Community Engagement to Advance Research and Community Health (CEARCH) 
•
Best Prac;ces Integrated Informa;cs Core (BPIC) 
•
CTSI Regulatory Manager | Clinical Research Monitor Group 
•
Clinical Research Liaison | Recruitment 
Reviewers provided detailed feedback, recommenda;ons and speciﬁc language from the 
panel of experts; developed a list of ac;on items for PI to complete, and provided follow up 
recommenda;on on next steps. 
Through our preliminary research (UMN IRB STUDY00005512; STUDY00000729; 
STUDY00006402), we established the founda;on for a novel approach to recovery from 
torture and war that will be used in the proposed feasibility pilot research plan. Preliminary 
data for this proposal is drawn from our previous community-engaged explanatory mixed 
methods research collected with maternal caregivers (N=96), and subsequently with paternal 
caregivers (N=48) and youth (N=72). Data collected from par;cipants included self-perceived 
mental health status28, family func;oning (FACES IV)29, youth adjustment (SDQ)30, and physical 
health variables. Analyses have been completed with the sample of 96 Karen refugee 
maternal caregivers from Burma living in the United States with caregiving responsibility for 
youth between the ages of 11 and 23. Maternal caregivers self-reported primary torture 
(26%), secondary torture (26%), or war trauma exposure (48%).23 We iden;ﬁed sta;s;cally 
signiﬁcant and posi;ve associa;ons between maternal exposure to torture/trauma, maternal 
mental health distress, maternal physical health, and youth adjustment. We iden;ﬁed 
complex interac;ons as to how these domains inﬂuenced each other in this context through 
extensive qualita;ve data collected via interviews with par;cipants. 
Preliminary results of a mul;ple linear regression model to predict overall youth 
adjustment (total scores on SDQ) reported by maternal caregivers indicated that self-reported 
age, gender, maternal mental health and maternal torture status signiﬁcantly predicted 
nega;ve adjustment in youth under 18 years, F(2, 166)= 6.111, p <.001, R2 =.128. Similar 
ﬁndings were shown for youth over 18 years, F(4, 102)= 3.876, p=.006, R2 =.132. SDQ 
subscales of Hyperac;vity, Prosocial and Emo;onal were signiﬁcantly predicted by child 
gender: maternal caregivers reported greater hyperac;vity behaviors for male youth; greater 
prosocial behaviors and emo;onal symptoms for female youth. In a bivariate linear regression 
model maternal torture exposure predicted higher emo;onal scores (more distress) in female 
youth (manuscript in review).22 
Further analysis suggested the rela;onship between torture and war trauma experiences 
and youth adjustment was completely mediated by maternal mental health distress. 
Moderated media;on analysis demonstrated that physical health problems was found to 
moderate the degree to which maternal mental health distress mediated the rela;onship 
between torture and war trauma experiences and youth adjustment. A stronger impact of 
maternal mental health distress on associa;ons between torture experiences and youth 
adjustment was observed in maternal caregivers who reported greater physical health 
Page  of 
 
Template Revised On: 09/01/2019
9
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
problems (i.e. pain, hypertension, gastrointes;nal disturbances). Recently, we have begun to 
examine the direct and indirect eﬀects of torture and war trauma experiences, family 
func;oning, mental health distress, physical health problems, youth gender and youth trauma 
exposure on youth adjustment in the integrated dataset including maternal and paternal 
caregivers, and youth. Preliminary path analysis suggested parent torture and family 
func;oning type have sta;s;cally signiﬁcant direct eﬀects on youth adjustment. Parent 
torture was found to have an indirect eﬀect on youth adjustment through the mental health 
and physical health problems of parents, and the gender and trauma exposure of youth. 
Family func;oning type demonstrated an indirect eﬀect on youth adjustment through youth 
gender, youth trauma exposure, parent physical health problems and parent mental health.  
Thus, our preliminary ﬁndings have enhanced a mechanis;c understanding that emo;onal 
and physiologic regula;on are key targets for recovery from intergenera;onal eﬀects of 
trauma. Our proposed research will directly address the intersec;on of mental and 
physiological health problems, youth adjustment, and family func;oning in trauma recovery.22 
2.3 Exis;ng Literature: The UN es;mates that 68.5 million people are forcibly displaced from 
their communi;es of origin because of fear of violence or persecu;on; 16.2 million people 
were newly displaced last year alone1. War trauma2 is a silent, global epidemic. Its impacts are 
pernicious and far-reaching. Almost universally, civilian survivors of conﬂict are exposed to 
individual and/or collec;ve war traumas. The direct exposure to psychological trauma or 
torture3 leads to well-documented individual health consequences. Less well characterized 
are the inclusive eﬀects of war trauma including sequalae impac;ng families and 
communi;es. Intergenera;onal trauma is deﬁned as the passage of trauma-related 
dysfunc;on experienced by one genera;on onto members of future genera;ons who were 
not themselves exposed to the original trauma.4 It is a phenomenon documented among 
groups that have experienced collec;ve trauma and systema;c oppression, most notably, 
survivors of the Holocaust and First Na;ons/Na;ve American communi;es.5,6 An emerging 
body of evidence highlights the signiﬁcance of intergenera;onal trauma among war-aﬀected 
families.7-15 In our proposed work, we will address the intergenera;onal transmission of 
emo;onal and behavioral disrup;ons due to parental trauma in war-aﬀected families. We 
propose a mindfulness-based interven;on (MBI) to target key underlying mechanisms 
iden;ﬁed in preliminary research. These include physical/soma;c and psychological trauma 
related symptoms, and key constructs of family func;oning, all germane to healthy youth 
development and family systems in war-aﬀected youth and families. Our study will be the ﬁrst 
to provide feasibility data for a family MBI to address paUerns of behavior that poten;ate 
intergenera;onal trauma in war-aﬀected youth and families. 
Youth adjustment in the context of forced displacement, migraMon, and intergeneraMonal 
trauma 
We deﬁne youth adjustment as the social, behavioral, cogni;ve, and rela;onal 
characteris;cs of a young person in a war-aﬀected family that inﬂuence adapta;on and 
Page 
 of 
 
Template Revised On: 09/01/2019
10
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
integra;on during post-migra;on or reseUlement. Observa;onal intergenera;onal trauma 
studies describe that child aUachment and psychosocial adjustment can be nega;vely aﬀected 
by parental trauma history. Symptoms of depression and anxiety are reported at higher levels 
among children with trauma;zed parents8, although factors such as family func;oning and 
resilience strategies can inﬂuence these associa;ons or func;on as protec;ve factors.9 For 
children whose parents have experienced torture, the eﬀects can be par;cularly striking. 
Having a parent who experienced torture contributes to a higher likelihood of children’s 
nega;ve mental health outcomes.8,10 Family narra;ves about trauma sequalae can also be 
important. For example, contradic;ons between what children of survivors are told and what 
they observe contribute to uncertainty and instability.11 
Children from families aﬀected by war and forced migra;on encounter a unique set of 
circumstances as they nego;ate reseUlement and integra;on. The capacity and resilience 
with which war-aﬀected youth nego;ate these circumstances is inﬂuenced by the strength of 
their familial and social networks. For example, among this group, familial factors such as 
intergenera;onal conﬂict or separa;on may protect or perpetuate trauma.12-17 
Intergenera;onal conﬂict is a highly relevant factor in the development of dual mental health 
and substance use disorders and overall adjustment among refugee youth.18 Addi;onally, war-
aﬀected youth are considered par;cularly vulnerable to gang recruitment.19 Poor familial 
dynamics are predic;ve of involvement in criminal and gang ac;vity.20 Gang-involved migrant 
youth had either experienced pre-migra;on trauma themselves or been impacted by their 
parents’ pre-migra;on experiences. Family violence, disintegra;on of rela;onships, and forms 
of absent, permissive or hos;le paren;ng are risk factors for gang involvement.21 There is a 
dearth of research focused on refugee adolescent adjustment and health. The proposed work 
will move the ﬁeld forward by developing and tes;ng an interven;on to address adolescent 
refugee adjustment. 
3. Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Results will demonstrate the feasibility of community 
based par;cipatory research strategies, recruitment, reten;on, ﬁdelity, data collec;on 
procedures, and the acceptability and adaptability of the interven;on. We are establishing 
training procedures where the PI and the community health interven;onists will be trained 
and evaluated in the delivery of the interven;on. Addi;onally we are merging two evidence 
based interven;ons, both of which will be adapted contextually to the context of a home-
based interven;on for war-aﬀected families with adolescent youth.  
Hypothesis 1a: The CBPR design u;lizing CHWI will demonstrate high interven;on impact 
measured by interven;on ﬁdelity, rates of comple;on of study milestones, and high 
par;cipant and CHWI sa;sfac;on. 
Hypothesis 1b: Recruitment and reten;on will be robust. The study team will meet 
recruitment targets and 85% of families will complete FMBI sessions and structured 
assessments within 3 months of enrollment. 
Page 
 of 
 
Template Revised On: 09/01/2019
11
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Hypothesis 1c: Acceptability and sustainability will be demonstrated through qualita;ve 
reports of engagement, safety of the interven;on, readiness to adopt, uptake, and perceived 
cultural congruence. 
3.2.Secondary Endpoint(s)/Event(s)/Outcome(s): Though purposely not powered to infer a causal 
rela;onship, we will examine trends in outcomes related to physical complaints and 
mindfulness related processes in youth and parents. These outcomes include: youth 
adjustment; mindfulness; emo;on regula;on; family func;oning and physiological regula;on.  
Hypothesis: FMBI will demonstrate preliminary improvements in outcomes listed above. 
4. Study IntervenMon(s)/InteracMon(s) 
1. Descrip;on: The Family Mindfulness Based interven;on will consist of two evidence based 
interven;ons, adapted contextually to the circumstances of war-aﬀected families in 
reseUlement, and integrated. The ﬁrst interven;on is the Aper Deployment Adap;ve 
Paren;ng Tools (ADAPT) interven;on. This is a 14 session group-based mindful paren;ng 
interven;on originally developed to increase emo;on regula;on among military caregivers 
with young children and improve youth adjustment.33-36  Parents will be invited to par;cipate 
in individual interviews post-program. The second interven;on is Learning To BREATHE, a 6 
session group-based interven;on targe;ng adolescent mindfulness.37-41 The adapted and 
merged interven;on will be delivered to individual families (home-based) in twice weekly 
sessions over a 7-week period by two community health worker interven;onists. Learning to 
Breathe was determined during pilot tes;ng to be more eﬀec;ve in the group format and the 
study team will return to the original delivery format of 6 group sessions. In addi;on to 
interven;on sessions, there will be an enrollment visit, where consent and pre-interven;on 
assessments are completed. Post-assessments and focus groups will be conducted 
immediately post-interven;on. The administra;ve and 7-week interven;on period will cover 
topics as described in the following table. 
Table 1. Schedule of visits including elements of the family mindfulness based 
Week
Caregiver (reﬂects adapted ADAPT 
interven;on)
Youth (reﬂects adapted Learning to 
BREATHE interven;on)
Pre-
Interven;on 
(120 minutes)
Enrollment and Consent 
Demographics 
Pre-assessments (listed table 2: 
caregiver, family, all)
Enrollment and Assent 
Demographics 
Pre-assessments (listed table 2: 
youth, family, all)
Page 
 of 
 
Template Revised On: 09/01/2019
12
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
5. Procedures Involved 
5.1. Study Design:  
We will test the feasibility of the family mindfulness-based interven;on with a reseUled 
popula;on of war-aﬀected families through a nonrandomized par;al cluster feasibility trial 
with embedded qualita;ve procedures. 
This will occur in 2 phases: 
1 (60 minutes)
Building Blocks of Resistance 
Give Eﬀec;ve Direc;ons 
Body 
Check in and prac;ce
2 (60 minutes)
Teach New Behavior 
Recognizing emo;ons 
Reﬂec;on 
Check in and prac;ce
3 (60 minutes)
Responding to Emo;ons 
Selng Limits 
Emo;ons 
Check in and prac;ce
4 (60 minutes)
Following Through 
Communicate with Children 
AUen;on 
Check in and prac;ce
5 (60 minutes)
Solving Problems 
Managing Conﬂict 
Tenderness 
Check in and prac;ce
6 (60 minutes)
Monitor children’s ac;vi;es 
Responding to Children’s Emo;ons
Health Mind Habits 
Check in and prac;ce
7 (60 minutes)
Building Skills: Linking home and 
school 
B l
i
k
d l
Post-
Interven;on 
(120 minutes)
Post interven;on assessments
Post interven;on assessments
Op;onal focus groups by role (60-90 minutes): Separate maternal, paternal, and youth 
focus groups
Page 
 of 
 
Template Revised On: 09/01/2019
13
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Phase 1: Interven;on adapta;on and Community Health Worker Interven;onist (CHWI) 
training through the delivery of the interven;on to Community Leadership Board (CLB) 
members and adolescent focus group 
Phase 2: Preliminary feasibility tes;ng of the FMBI with members of the Karen community 
5.2. Study Procedures:  
Phase 1: 
Community Leadership Board 
The CLB will be made up of 4-7 Karen professionals represen;ng prominent local 
organiza;ons suppor;ng Karen refugees in reseUlement. Representa;ves will have lived 
cultural and historical exper;se as well as professional exper;se suppor;ng the reseUled 
community from mental health and social services perspec;ves. The exper;se of the 
board ensures culturally centered prepara;ons for interven;on dissemina;on. The CLB 
will take an ac;ve role in the adapta;on of the interven;on. At the end of Phase 1 the 
board will determine the frequency of mee;ngs through Phase 2. 
CHWI Training 
•
Watch 25 hour ADAPT training video 
•
50 hours of training with cer;ﬁed ADAPT facilitator for training, role play, and feedback 
•
ADAPT facilitator will provide 80 hours coaching based on based on recorded sessions 
•
15 hours training with cer;ﬁed Learning to Breathe facilitator 
AdaptaMon/CHWI coaching 
•
In Phase 1 the CLB will meet twice per week for 6 weeks. At each mee;ng the CHWI will 
present an interven;on module to the CLB via Zoom. This will be recorded and later 
watched by the interven;on facilitator to provide coaching to the CHWI. Members of the 
CLB will be aware of and agree to the session recording. 
•
Zoom sessions will include a brief group debrief following session (ques;ons below) 
•
Adapta;ons to interven;on content will be made based on this work and summarized and 
submiUed as modiﬁca;on to the IRB.  
•
Final CLB mee;ng where present summary of ﬁnal program is presented and discussed. 
•
In phase 2, interven;on sessions with families will be audio/video recorded for the 
purposes of coaching and ﬁdelity monitoring. Videos will be stored in UMN Box and 
transcribed. The focus of the recording is the interven;onist, not the research par;cipant. 
CLB debrieﬁng quesMons (aper each session and ﬁnal related to overall program): 
What did you like about this session? 
What did you not like about this session? 
What are some ways we improve the session? 
Was there anything missing from the session? 
Page 
 of 
 
Template Revised On: 09/01/2019
14
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Are there ways we should change the session to beUer meet the needs of Karen parents? 
What will barriers be to par;cipa;on? 
What can the study team do to facilitate par;cipa;on? 
Youth Focus Group 
CHWI from WellShare Interna;onal will lead the recruitment of adolescent youth from the 
exis;ng cohort of families. We will also reach out to organiza;onal partners for recruitment 
support. If this is conﬁrmed, we will submit recruitment materials to the IRB as a modiﬁca;on. We 
will conduct up to two focus groups via Zoom with 5-6 youth par;cipants in each group. Consent/
assent procedures are described further. 
Following assent, the CHWI will provide a descrip;on of the interven;on including the focus of 
each of the 6 sessions, and the types of ac;vi;es that will be part of the session. The CHWI will 
then ask par;cipants to discuss the following: 
Focus Group QuesMons: 
Would consider par;cipa;ng in this program? Why or why not? 
How do you think this interven;on could be helpful to you? 
What would kinds of things would you want to see included in the program? 
What do you not want to see included in the program? 
What would barriers to par;cipa;ng in the program be/what would prevent you from 
par;cipa;ng? 
What could the project team to help make it possible for you to par;cipate in the program? 
What do you think about ;mes during the program where you and your parents are learning 
together? 
9/10/21 This update is relevant to youth participation in STUDY 00011195. We are not making any 
adaptations to the Learning to Breathe curriculum, and/or procedures proposed in the original 
protocol.   
Six community health workers engaged in the migrant/refugee youth programming at WellShare 
International participated in the full Learning to Breathe intervention training with a goal of 
evaluating the acceptability of the intervention. It was highly endorsed and there were no 
recommended adaptations to the curriculum. We are still considering group-based versus 
individual delivery format, and will conduct a youth focus group following implementation to 
further exlore this. We will keep the proposed individual format as is through the fall pilot. This 
modification was based on the PIs conversation with the IRB committee and I am submitting this 
modification to confirm the activities has been completed. 
Page 
 of 
 
Template Revised On: 09/01/2019
15
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Phase 2: 
Phase 2 procedures are designed to test the feasibility of the of the family mindfulness based 
interven;on and the preliminary impact of the program on key outcomes derived through early 
project phases. Speciﬁcally in this phase of the research our feasibility focus is the CBPR approach 
and interven;on delivery by community health worker interven;onists. Two Karen 
interven;onists (who are both members of the Karen community, employed as community health 
workers at WellShare Interna;onal) will lead the recruitment and enrollment of 10-12 families. 
Community health worker interven;onists will be listed as study staﬀ on the IRB submission. The 
9-week study period will include: 7-week home-based interven;on delivery (60 minutes per 
biweekly session) and 2 weeks of pre/post assessments (120 minutes each). Youth will par;cipate 
in a group delivery format. The format will be in person groups consis;ng of 5-10 group members. 
The loca;on of the group will be the Knyaw Bap;st Church. Masks will be required and social 
distancing will be promoted. Groups will only consist of youth taking part in the interven;on. 
Parents will have the op;on of transpor;ng children, or transporta;on by the church van will be 
arranged as an alterna;ve. Youth will be instructed that all content of the interven;on sessions is 
to remain conﬁden;al. Youth will be reminded at the start of each session that the iden;;es of 
their fellow par;cipants and informa;on shared are conﬁden;al, and they should only share what 
they would be comfortable with others knowing since there is no guarantee that this informa;on 
will stay within the group. 
An op;onal later 60-90 minute focus group will be oﬀered 1-month post-interven;on for youth. 
Parents will be invited to par;cipate in individual interviews. Cost of transporta;on and childcare 
will be supported for focus group par;cipants and each par;cipant will receive a $15 gip card for 
par;cipa;on. Ques;ons will target success and challenges par;cipants have had implemen;ng 
the skills taught in the interven;on, as well as general percep;ons of the interven;on 1-month 
aper the program end. Coordinators will have par;cipated in the reﬁnement and implementa/on 
of the interven;on in Aim 1. Study coordinators and local interven;onists will be trained 
interven;on facilitators based at the University of Minnesota. Fidelity observa;ons will be made 
weekly by study team members/trainers. As part of feasibility tes;ng we will monitor par;cipant 
adherence to the study protocol and the challenges that prevent families’ full par;cipa;on in 
aUending interven;ons sessions. Study visits that take place +/- 2 days of target visit date will be 
considered ‘on ;me’. Visit outside of this ;meframe will be considered delayed. If a family 
member misses a scheduled visit, it will be documented as “missed”. 
Ac;vi;es of phase 2 are con;ngent on the comple;on of phase 1 and IRB approval of all 
modiﬁca;ons to the interven;on and/or proposed study protocol. 
Regarding in person versus remote interac;ons, we are developing two models, depending on the 
circumstances of Covid-19 in the Summer-Fall 2021 (intensive data collec;on phase). We plan to 
follow all Federal/CDC guidelines as appropriate. We an;cipate a hybrid implementa;on in that 
we will have families that prefer the telehealth op;on and familes that prefer in person. 
Page 
 of 
 
Template Revised On: 09/01/2019
16
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
•
Model A - WellShare CHWs are currently conduc;ng telehealth visits by phone or video. If 
the circumstances surrounding Covid-19 persist into the summer-fall 2021 we will conduct 
all study procedures through remote technology. 
•
Model B – If the circumstances allow, we will plan for data collec;on and interven;on 
sessions to be conducted in person, outdoors.  
We are planning for study personnel and par;cipant PPE should this be necessary. The School 
of Nursing Oﬃce for Nursing Research and Scholarship will provide PPE funds if necessary. 
5.2.1.
The project is a pilot study and therefore all ac;vi;es are occurring for research purposes. 
5.2.2.
Pre and post assessments are listed in Table 2. These will be wriUen assessments and will 
be available in English and Karen languages. In the case that a par;cipant is not able to 
read or prefers to have the ques;ons aloud, the community health worker interven;onist 
will be delivered verbally. 
Table 2. Aim 2 assessments
Instrument
Outcome 
CharacterisMcs
Item sample
Psychometrics
CitaMon
Youth (youth complete)
Strengths and 
Diﬃcul/es 
Ques/onnaire 
(SDQ I/S)
Youth 
adjustment 
A 25-item 
youth 
behavioral 
screening 
ques;onnaire 
Oien 
complains of 
headaches, 
stomach-
aches or 
sickness.
α = 0.82  
(total 
diﬃcul;es)
Goodman 
et al., 
199828
Cogni/ve and 
Aﬀec/ve 
Mindfulness 
Scale-Revised 
(CAMS-R)
Mindfulness A 12-item 
assessment of 
mindfulness as 
a single 
construct 
It is easy for 
me to 
concentrate 
on what I am 
doing.
α = 0.74-0.77
Feldman et 
al., 200729
Page 
 of 
 
Template Revised On: 09/01/2019
17
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
UCLA Brief 
Screen for Child/
Adolescent 
Trauma and 
PTSD
Youth 
trauma 
history, 
PTSD 
screening
A 11-item (+2 
open ended) 
evalua;on of 
trauma history 
and PTSD 
symptoms for 
iden;fying at-
risk cases
I have trouble 
concentra/ng 
or paying 
a+en/on.  
α > .93 
Rolon-
Arroyo et 
al., 2020
Emo/on 
Regula/on Skills 
Ques/onnaire 
(ERSQ)
Emo;on 
regula;on
A 27-item 
assessment of 
emo;on 
regula;on 
skills described 
in the ART83 
model
My physical 
sensa/ons 
were a good 
indica/on of 
how I was 
feeling.
α = .96 
Grant et al. 
201830
Caregiver (caregivers complete)
Karen Mental 
Health Screener 
– Brief (KMHS-B)
Parent 
mental 
health 
distress
5-item 
measure 
developed to 
screen for 
mental distress 
associated 
with MDD and 
PTSD 
In the past 
month, have 
you been 
unable to 
concentrate, 
remember 
things, or 
make 
decisions?
α = 0.83
Brink et al., 
201527
Cogni/ve and 
Aﬀec/ve 
Mindfulness 
Scale-Revised 
(CAMS-R)
Mindfulness A 12-item 
assessment of 
mindfulness as 
a single 
construct 
It is easy for 
me to 
concentrate 
on what I am 
doing.
α = 0.74-0.77
Feldman et 
al., 200729
Emo/on 
Regula/on Skills 
Ques/onnaire 
(ERSQ)
Emo;on 
regula;on
A 27-item 
assessment of 
emo;on 
regula;on 
skills described 
in the ART83 
model
My physical 
sensa/ons 
were a good 
indica/on of 
how I was 
feeling.
α = .96 
Grant et al. 
201830
Family FuncMoning (all complete)
Page 
 of 
 
Template Revised On: 09/01/2019
18
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
5.3. Follow-Up: Currently we plan to collect pre/post interven;on and focus group data 
only. If addi;onal funds are obtained will add a 6 month follow up assessment. If this 
is the case, we will submit an addendum to this protocol. Parents who complete the 
ADAPT interven;on will be invited to conduct a 1:1 in depth interview about their 
experiences in the program. This will occur in the home and an incen;ve of $10 will 
be provided. 
5.4.
Individually Iden;ﬁable Health Informa;on: This study will include individually 
iden;ﬁable health informa;on but will not include data from medical records. See 
sec;on 18.0. Par;cipants will be asked to sign a combined ICF/HIPAA form before 
comple;ng any study procedures.  
6. Data Banking 
6.1. Storage and Access: De-iden;ﬁed data collected from the pre- and post- assessment 
measures in this study may be used in collated fashion for future peer-reviewed 
publica;ons or other scien;ﬁc communica;ons.  
6.2. Data: For subject screening we will be using a phone script. We will include an 
eligible/not eligible ﬁeld in the RedCAP databased to document eligibility for each 
par;cipant. Demographic data and pre/post will be collected during the enrollment 
visit via pen/paper. Demographic informa;on and responses to pre/post instruments 
will be entered into a par;cipant study record in RedCAP. Par;cipant IDs will be 
assigned to par;cipants and linked to iden;fying informa;on in a spreadsheet 
housed in the UMN Box plahorm. Study records including hard copies of 
assessments will be destroyed three years aper the close of the study. Community 
Family 
Adaptability and 
Cohesion Scale IV 
(FACES)
Family 
func;oning
A 42-item 
assessment of 
cohesion & 
ﬂexibility
Family 
members are 
suppor/ve of 
each other 
during diﬃcult 
/mes.
Alpha 
reliability 
range 
subscales:  
α = .77-.89
Olson, 
201127
Physiological RegulaMon (all complete)
Cohen-
Hoberman 
Inventory of 
Physical 
Symptoms 
(CHIPS)
Physical 
health 
status 
A 39-item 
assessment of 
perceived 
burden from 
physical 
symptoms
How much 
were you 
bothered by: 
Back pain 
Cons/pa/on 
Dizziness
α = .88
Cohen & 
Hoberman, 
198331
Page 
 of 
 
Template Revised On: 09/01/2019
19
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
health workers will not be collec;ng data during the interven;on delivery. The PI or 
designated member of the study team will record study visits in an excel document 
housed in UMN Box. Interven;on session visits will be tape (audio) and video 
recorded to evaluate interven;on ﬁdelity (i.e. focus of the recording is the delivery of 
the interven;on by the Community Health Worker Interven;onists). Por;ons of 
these recordings will be transcribed for coaching purposes. For Zoom sessions, 
Zoom’s closed cap;oning will be used for transcrip;on because we do not an;cipate 
encountering during interven;on sessions. We will seek a BAA excep;on for the HCC 
account. All transcrip;ons will be de-iden;ﬁed. Because the recordings will also be 
used in coaching sessions with an interven;on facilitator involved in training the 
community health worker interven;onists, they will not be immediately destroyed. 
Recordings will be destroyed along with hard copy study records within three years 
of the close of the study. Recordings will be downloaded as soon as possible 
following the study interac;on and then deleted from the recording device. 
Recording devices will be in the possession of the study team member un;l the 
recording is deleted. All recordings will be stored in UMN Box. 
6.3. Release/Sharing: Individual data will not be released. Community Health Worker 
Interven;onists will par;cipate in the analysis and interpreta;on of data. Aggregate 
ﬁndings will be disseminated to the community in partnership with WellShare 
Interna;onal (community partner).  
7. Sharing of Results with ParMcipants 
7.1. Individual data will not be shared among par;cipants. Aggregate ﬁndings will be 
disseminated to the community in partnership with WellShare Interna;onal 
(community partner).  
8. Study DuraMon 
8.1. Describe: 
8.1.1.The dura;on an;cipated for adolescents par;cipa;ng in Phase 1 focus group is 
1 hour. The dura;on an;cipated for an individual par;cipant’s par;cipa;on in 
the Phase 2 ac;vi;es of the study is approximately 20 hours over 8 weeks 
including interven;on and administra;ve visits.  
8.1.2.The dura;on an;cipated to enroll Phase 1 study par;cipants is 1 week. 
Dura;on an;cipated to enroll all Phase 2 study par;cipants is 3 months 
8.1.3.The dura;on an;cipated to complete all study procedures and data analysis is 
12 months 
9. Study PopulaMon 
9.1 Inclusion Criteria:  
Adult inclusion criteria:  
a) Above the age of 18 
Page 
 of 
 
Template Revised On: 09/01/2019
20
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
b) Karen refugees reseUled to the United States greater than one year prior to enrollment 
c) Caregiving responsibility for at least one child between the ages of 11 and 18 
d) Reported primary or secondary torture or war trauma exposure, based on assessments 
conducted during UMN IRB STUDY00000729 
e) Par;cipa;on in UMN IRB STUDY00000729 and having agreed to be contacted for future 
research 
Youth inclusion criteria: 
a) Ages 11 to 18 
b) Living in the home with the primary caregivers 
c) Considered a dependent of the primary caregivers (s;ll in high school or transi;oning from 
school to work force, not married and/or raising their own children – will take individual youth 
circumstances into considera;on individually to make a determina;on of dependence)  
9.2 Exclusion Criteria 
Exclusion criteria (applies to both adult and youth par;cipants): 
a) Self-reported or study team observed severe or unstable mental or physical illness such as: 
acute psychosis, presence or risk of safety concerns, and/or a physical disability or illness, 
which prevents the poten;al par;cipant from engaging in the study ac;vi;es. Youth will be 
excluded if screening is posi;ve for PTSD. Caregivers will not be excluded if mental health 
screening is posi;ve for PTSD/severe depression. 
b) Nonbiological caregiving rela;onships with child 
c) If one member of the family declines to par;cipate in the ini;al enrollment, the family will 
be excluded. If the randomly selected index youth declines to par;cipate, we will open 
enrollment to other youth in the family that meet the inclusion criteria. 
9.3 Screening: Karen families will be recruited from an exis;ng cohort of 96 Karen families that 
par;cipated in preliminary observa;onal studies and gave consent to be contacted for poten;al 
involvement in future phases of the research (UMN IRB STUDY00005512 and STUDY00000729). 
Par;cipa;on in previous study phases will not impact the proposed trial. Two Karen community 
health worker interven;onists will be prepared to assist poten;al and assigned par;cipants in all 
aspects of the study—from recruitment and consent processes, to interven;on delivery, data 
collec;on, and ﬁnal evalua;on interviews.  
In phase 1 our recruitment target is up to 12 adolescent youth age 11-18 to par;cipate in 5-6 
member focus groups, each group mee;ng up to 3 ;mes. One parent will give verbal consent 
over the phone. Youth assent will be conﬁrmed at the beginning of the focus group session. Focus 
group sessions will take place over Zoom and will be facilitated by the CHWI with the PI present. 
Zoom sessions will be audio only recorded and any Karen language discussion will be transcribed 
by CHWI. All transcrip;ons will be de-iden;ﬁed.  
Page 
 of 
 
Template Revised On: 09/01/2019
21
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
In phase 2 our recruitment target is N=10-12 families, inclusive of the maternal caregiver, paternal 
caregiver (when present), and one randomly selected index youth per family age 11-18. At the 
ini;al contact with poten;al par;cipants (phone call), the community health worker/Karen 
interven;onist will explain study procedures such as voluntary par;cipa;on and what 
par;cipa;on in the interven;on entails. Poten;al par;cipants will be oﬀered the opportunity to 
ask ques;ons about study procedures. A second, in person encounter will be scheduled if the 
poten;al par;cipant expresses interest in study par;cipa;on. At a second encounter (face to face 
in par;cipant homes or preferred alterna;ve loca;on or via Zoom if remote is preferred) 
con;nued interest in par;cipa;on will be assessed. Parents and youth will be screened for 
eligibility, and informed consent and assent will be obtained. Baseline data collec;on will be 
obtained at this second encounter. Interven;on sessions will begin within one month of 
enrollment. 
10. Vulnerable PopulaMons 
10.1.Vulnerable Popula;ons:  
Popula;on / Group
Iden;fy whether any of the 
following popula;ons will be 
targeted, included (not necessarily 
targeted) or excluded from 
par;cipa;on in the study. 
Children
Targeted Popula;on
Pregnant women/fetuses/neonates
Included/Allowed to Par;cipate
Prisoners
Excluded from Par;cipa;on
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical condi;ons, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders
Excluded from Par;cipa;on
Non-English speakers
Included/Allowed to Par;cipate
Those unable to read (illiterate)
Included/Allowed to Par;cipate
Employees of the researcher
Excluded from Par;cipa;on
Students of the researcher
Excluded from Par;cipa;on
Page 
 of 
 
Template Revised On: 09/01/2019
22
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
10.2 Addi;onal Safeguards:  
The study team will base a trauma informed approach on SAMHSA’s 6 KEY PRINCIPLES OF A 
TRAUMA-INFORMED APPROACH: 
1. Safety  
2. Trustworthiness and Transparency  
3. Peer Support  
4. Collabora;on and Mutuality  
5. Empowerment, Voice and Choice  
Undervalued or disenfranchised 
social group
Targeted Popula;on
Ac;ve members of the military 
(service members), DoD personnel 
(including civilian employees)
Included/Allowed to Par;cipate
Individual or group that is 
approached for par;cipa;on in 
research during a stressful situa;on 
such as emergency room selng, 
childbirth (labor), etc.
Excluded from Par;cipa;on
Individual or group that is 
disadvantaged in the distribu;on of 
social goods and services such as 
income, housing, or healthcare.
Targeted Popula;on
Individual or group with a serious 
health condi;on for which there are 
no sa;sfactory standard treatments.
Included/Allowed to Par;cipate
Individual or group with a fear of 
nega;ve consequences for not 
par;cipa;ng in the research (e.g. 
ins;tu;onaliza;on, deporta;on, 
disclosure of s;gma;zing behavior).
Included/Allowed to Par;cipate
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploita;on that might 
inﬂuence consent to research or 
decision to con;nue in research.
Included/Allowed to Par;cipate
Page 
 of 
 
Template Revised On: 09/01/2019
23
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
6. Cultural, Historical, and Gender Issues  
The framework will be implemented through a number of strategies, including but not limited to: 
Karen community health worker interven;onist model, stakeholder-led interven;on 
development/adapta;on, home-based interven;on delivery, par;cipant led consent and assent 
discussions, family involvement, and community advisory board input/oversight. 
Illiterate: 
Pa;ents who are illiterate may not be known, research staﬀ will not be asking a direct ques;on 
about literacy to poten;al par;cipants. However, if it's made known to us that the pa;ent is 
illiterate we will take extra care to go through the consent form and read it to the poten;al 
par;cipant. Vulnerability for this group will not be increased by par;cipa;ng in this study. 
Undervalued and Disadvantaged: 
Disadvantaged and disadvantaged people may not be known, research staﬀ will not be asking a 
direct ques;on about socioeconomic status to poten;al par;cipants. Vulnerability for this group 
will not be increased by par;cipa;ng in this study. 
Fear of Nega;ve consequences: 
Individuals with a fear of nega;ve consequences for not par;cipa;ng in the research (e.g. 
ins;tu;onaliza;on, deporta;on, disclosure of s;gma;zing behavior) are not targeted but may be 
enrolled. All par;cipants will be fully informed that the study is completely voluntary and that 
they may withdraw par;cipa;on at any ;me. They will also be reminded that their rela;onship 
with their provider or the UMN will not be aﬀected by their decision whether or not to par;cipate 
in this study. 
10.1.1.Pregnant Women 
The inclusion of pregnant women will be incidental. This study does not include an interven;on, 
biologic or other greater than minimal risk procedure. No inducements, monetary or otherwise, 
will be oﬀered to terminate a pregnancy. Individuals engaged in the research will have no part in 
any decisions as to the ;ming, method, or procedures used to terminate a pregnancy. 
Individuals engaged in the research will have no part in determining the viability of a neonate. All 
par;cipants will be provided   assurance of conﬁden;ality, the freedom to decline to par;cipate 
and the right to withdraw at any ;me without penalty. All par;cipants will be reassured that their 
decision to par;cipate or not patriciate in this study will have no eﬀect on their current prenatal 
care. 
10.1.2.
NA 
10.1.3.
NA 
10.1.4.
Youth ages 11-18 will be recruited to par;cipate in an adolescent mindfulness curriculum.  
Page 
 of 
 
Template Revised On: 09/01/2019
24
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Children are the targeted popula;on for this study because the study aims could not be assessed 
without children. Study procedures have been minimized to exclude all unnecessary procedures 
that would not contribute to the scien;ﬁc objec;ve. The inves;gators believe that the risks to 
par;cipants are no greater than minimal in rela;on to the importance of the knowledge that may 
be expected to result. Permission by one or more parents or guardians and assent (when 
appropriate) by the child will be solicited. All par;cipants will be provided assurance of 
conﬁden;ality, the freedom to decline to par;cipate and the right to withdraw at any ;me 
without penalty. 
10.1.5.
NA 
10.1.6.
Refugees inherently experience inequity of wealth and access. A majority of Karen 
refugees reseUled in Minnesota are Karen-speaking only. Civilian survivors of conﬂict, almost 
universally, experience individual and/or collec;ve war traumas. Psychological trauma and torture 
experienced by war-aﬀected individuals is strongly associated with signiﬁcant and long-term 
individual mental and physical health eﬀects. It has more recently been observed that the eﬀects 
of a trauma experienced by a parent nega;vely inﬂuence the health of the family system and 
healthy youth development. Trauma treatment oﬀers important and eﬀec;ve elements in 
recovery in war-aﬀected individuals, but these programs remain predominantly centered on 
individual recovery. The intergenera;onal impact of trauma is overlooked, thus deepening health 
dispari;es experienced by an already vulnerable popula;on. With growing knowledge of the 
connec;on between mind, body and trauma, par;cularly informed by the emerging disciplines of 
neuroscience, developmental psychopathology, and interpersonal neurobiology, we understand 
that trauma experiences are felt, stored, and expressed by the body. This proposal integrates 
perspec;ves and methods from these and other disciplines to introduce, through mindfulness, a 
community-based interven;on that promotes posi;ve emo;onal and behavioral development of 
war-aﬀected youth and family systems.  
10.1.7.
See above for descrip;on of popula;on and alignment with aims. 
10.1.8.See above descrip;on of risk. 
11. Number of ParMcipants 
11.1. Number of Par;cipants to be Consented in phase 1: 10-12 youth; in phase 2: 
Es;mated 50 or less (maternal, paternal, youth) 
12. Recruitment Methods 
12.1. Recruitment Process:  
Page 
 of 
 
Template Revised On: 09/01/2019
25
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
For youth par;cipa;ng in phase 1 focus groups, we recruit from the exis;ng cohort. We will 
also reach out to organiza;onal partners for recruitment support. If this is conﬁrmed, we will 
submit recruitment materials to the IRB as a modiﬁca;on.  
(See above also, sec;on 8.3). In phase 2 Karen families will be recruited from an exis;ng 
cohort of 96 Karen families that par;cipated in preliminary observa;onal studies and gave 
consent to be contacted for poten;al involvement in future phases of the research (UMN IRB 
STUDY00005512 and STUDY00000729). Par;cipa;on in previous study phases will not impact 
the proposed trial. Poten;al Karen par;cipants will also be recruited through iden;cal 
methods by targeted recruitment based on family engagement with community partner 
(WellShare Interna;onal) programming, e.g. involvement in Karen youth programming, 
tobacco cessa;on programming, or via referral through established partnerships to WellShare 
paren;ng support programming. Two Karen community health worker interven;onists will be 
prepared to assist poten;al and assigned par;cipants in all aspects of the study—from 
recruitment and consent processes, to interven;on delivery, data collec;on, and ﬁnal 
evalua;on interviews. Our recruitment target in phase 2 is N=10-12 families, inclusive of the 
maternal caregiver, paternal caregiver (when present), and one randomly selected index 
youth per family age 11-18. At the ini;al contact with poten;al par;cipants (phone call), the 
community health worker/Karen interven;onist will explain study procedures such as 
voluntary par;cipa;on and what par;cipa;on in the interven;on entails. The eligibility of the 
selected youth will also be conﬁrmed in this ini;al contact.  Based on past studies this ini;al 
point of contact will likely be the maternal caregiver. Poten;al par;cipants will be oﬀered the 
opportunity to ask ques;ons about study procedures. A second, in person encounter will be 
scheduled if the poten;al par;cipant expresses interest in study par;cipa;on. At a second 
encounter (face to face in par;cipant homes or preferred alterna;ve loca;on) con;nued 
interest in par;cipa;on will be assessed. Parents and youth will be met with individually, in 
private, and screened for eligibility, and informed consent and assent will be obtained. Youth 
can determine whether a parent remains present for study procedures. Baseline data 
collec;on will be obtained at this second encounter. Interven;on sessions will begin within 
one month of enrollment. Par;cipants will be given a copy of their signed and dated consent/
assent forms. 
12.2. Source of Par;cipants: An exis;ng cohort. 
12.3. Iden;ﬁca;on of Poten;al Par;cipants:  
Par;cipants will be iden;ﬁed and recruited from an exis;ng cohort or through CHWI 
iden;ﬁed poten;al par;cipants based on family engagement with community 
partner (WellShare Interna;onal) programming, e.g. involvement in Karen youth 
programming, tobacco cessa;on programming, or via referral through established 
partnerships to WellShare paren;ng support programming. 
12.3.1.
Page 
 of 
 
Template Revised On: 09/01/2019
26
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
NA 
12.3.2.
WellShare Community Health Worker Interven;onists (Karen) 
12.3.3.
No medical records will be accessed. 
12.4. Recruitment Materials:  
Phone recruitment phone script submiUed with ETHOS materials. 
12.5. Payment:  
In phase 1 youth will be compensated $20 per focus group session aUended. In phase 
2 individuals will be compensated $10 each at each study visit (2 data collec;on visits 
+ 12 study visits over 6 weeks), totaling $140 per individual/$420 per family if full 
par;cipa;on. Focus group par;cipants will individually receive $15 per session. 
Transporta;on and childcare will be provided for focus group aUendance. These 
amounts are based on community norms and the recommenda;on of WellShare 
Interna;onal. 
12.5.1.
See above, par;cipants will receive visa gip card incen;ves.  
12.5.2.In phase 1 youth could receive up to $60 if they par;cipate in the maximum of 3 
focus group sessions. In phase 2 families may receive up to $420. Individuals may 
receive up to $140. Individuals may receive an addi;onal $15 for focus group 
par;cipa;on.  
12.5.3.
Visa gip card incen;ves will be given at each study encounter. Payments will not be 
prorated. 
12.5.4.
Par;cipants will receive gip cards.  
12.5.5.
NA 
12.5.6.
No, Greenphire ClinCard will not be used. 
13. Withdrawal of ParMcipants 
13.1.Withdrawal Circumstances:  
Page 
 of 
 
Template Revised On: 09/01/2019
27
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
We do not an;cipate circumstances under which this would occur. Par;cipants are free to 
withdraw at any;me during the study. 
13.2.Withdrawal Procedures:  
If a par;cipant wishes to withdraw or we determine that the par;cipant should withdraw, we 
will terminate data collec;on and discuss with the par;cipant the reasons for withdraw. All 
data collected up to that point will be used in analysis unless the par;cipant wishes for their 
data not to be used. The date and reason for par;cipant discon;nua;on or withdrawal from 
the study will be recorded on the par;cipant’s Case Report Form (CRF). 
13.3.Termina;on Procedures: 
If a par;cipant withdraws from the study, the study team will request permission to use data 
collected up to the withdrawal point. 
14. Risks to ParMcipants 
14.1. Foreseeable Risks:  
Interven;on response: Understood risks involved in par;cipa;on in mindfulness-based 
interven;ons are minimal, par;cularly when developed and delivered through a trauma 
informed approach.  
Instruments and Ques;onnaires: It is possible that structured and or qualita;ve 
assessments could bring up painful memories and/or par;cipants could experience 
distress or psychological discomfort. This did not occur in the earlier phases of the project, 
where more sensi;ve ques;ons were asked of par;cipants in order to establish a 
mechanism of ac;on from which to target interven;on. Therefore, we consider the 
likelihood of occurrence of this degree of risk to be low. We will have a trained clinician 
available for consulta;on during and aper each interven;on session to guard against this 
concern. Nega;ve reac;ons requiring a clinician’s interven;on, if any, will be an important 
indicator for reﬁnements to the interven;on. 
If follow up services are required, par;cipants who experience distress will be referred for 
same day services through the Wilder Founda;on or Ramsey County Urgent Care for 
Adult/Child Mental Health. Both organiza;ons have Karen linguis;c and cultural resources 
available. 
At the beginning of each interven;on session, the facilitator will ask par;cipants to 
disclose if they experience any nega;ve feelings during the session. If this becomes the 
case, the par;cipant will be asked if he/she wants to stop par;cipa;on in the session. In 
the case of youth par;cipants, the interviewer will inform the parent/guardian. If a 
par;cipant reports signiﬁcant distress, or otherwise emergent issue, data collec;on will 
Page 
 of 
 
Template Revised On: 09/01/2019
28
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
stop. The PI will be immediately contacted to discuss the situa;on. A safety plan will be 
developed with the study coordinator, one or both of the mental health resources 
iden;ﬁed above, and consulta;on with the mentor team and community partner 
organiza;ons.  
Distress may present in a variety of ways. If distress occurs, the community health worker 
interven;onist will remain with the par;cipant/family. The PI will always be available for 
consulta;on during study visits. Once the CHWI has reached the PI, a safety plan will be 
developed. In urgent or emergent circumstances, the Ramsey County Urgent Care for 
Adult/Child Mental Health will be consulted. The CHWI and/or PI and/or capable caregiver 
will stay with the par;cipant to ensure safety un;l a safety plan is established and an 
appropriate crisis interven;on handoﬀ is established. The threshold for interven;on or 
withdrawal will be determined by the par;cipant, the community health worker 
interven;onist, and the PI and will be based on the unique circumstances of the 
encounter. Referrals will be made upon request, and rou;nely in the event that a caregiver 
scores 4 or above on the Karen mental health screening tool or youth score 21 or higher 
on the DSM-5 PTSD diagnos;c screener (if not already receiving services). Rou;ne 
referrals will not automa;cally exclude a par;cipant from par;cipa;ng or con;nuing in the 
research. 
A support study team member/co-facilitator (Marry Htoo) will be present for each group 
session. The lead facilitator (Hsa Moo) will instruct youth to let the co-facilitator know if 
they become distressed. If this is the case the co-facilitator will locate a private space for 
her and the par;cipant to address the response. The primary facilitator can then con;nue 
with the rest of the session. The PI will be immediately contacted by the co-facilitator to 
discuss the situa;on and develop a safety plan. The co-facilitator is Karen speaking and will 
also call to inform the parent/guardian. If a par;cipant experiences signiﬁcant distress the 
co-facilitator and PI will follow the steps outlined above. The co-facilitator will also have 
primary responsibility for monitoring for signs of distress during the group and invi;ng 
youth who show signs of distress to check in individually.  
Risk of loss of conﬁden;ality is unlikely, but could possibly occur as PHI is u;lized as part of 
this study. The risk would be minimized by protec;ons such as de-iden;ﬁca;on of 
par;cipants via use of a study iden;ﬁer, locked/secured/limited access to PH, and 
electronic data securely stored and password protected. 
14.2. Reproduc;on Risks:  
NA 
14.3. Risks to Others:  
NA 
15. Incomplete Disclosure or DecepMon 
Page 
 of 
 
Template Revised On: 09/01/2019
29
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
15.1. Incomplete Disclosure or Decep;on:  
15.1.1.
NA 
15.1.2.
NA 
15.1.3.
NA 
16. PotenMal Beneﬁts to ParMcipants 
16.1. Poten;al Beneﬁts:   
Individuals/families who par;cipate in the interven;on may learn new individual coping 
and mindfulness skills as well as family communica;on, conﬂict resolu;on, and problem-
solving tools. Long term impact includes the development of a family mindfulness-based 
interven;on that may be adapted across diverse cultural and migrant groups and is 
eﬀec;ve in regula;ng the eﬀects of trauma through behavioral and environmental 
mechanisms. 
17. StaMsMcal ConsideraMons 
17.1. Data Analysis Plan:  
Paired t tests will be used to examine intra-individual changes between baseline and 
post-group scores. Cohen’s d eﬀect sizes quan;fy the magnitude of poten;al 
changes detected in outcomes, .2 is small, .5 is medium and .8 or higher is large.75 
Within families, we will ﬁrst evaluate congruence between the maternal-child dyad 
interven;on response because we an;cipate these data are more likely to have 
completeness. Within families, congruence in maternal and paternal caregiver 
interven;on response will be evaluated. If there are diﬀerences between mothers 
and fathers, we will conduct a cluster analysis. Missing data will be handled through 
data imputa;on. Qualita;ve approaches will assess the feasibility of local 
interven;onists and CBPR strategies. Interviews and focus group transcripts will be 
analyzed through content analysis and cross-case comparisons. Open coding will 
ini;ate the development of labels and concepts. Through paUern coding we will 
create categories of codes. Axial coding will allow for a considera;on of rela;onships 
between categories. During data reduc;on analy;c documenta;on will facilitate the 
arrangement of data into conceptual clusters.76 
17.2. Power Analysis: The proposed pilot is underpowered. 
A power analysis for the primary outcome youth adjustment for paired t tests 
between pre and post interven;on outcome measures was performed a priori in 
nQuery Advanced to determine the adequate sample size with an alpha of 0.05, a 
Page 
 of 
 
Template Revised On: 09/01/2019
30
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
power of .80 and an eﬀect size =.45 (small to moderate). The power analysis 
determined a total sample size of 41 (without aUri;on), to detect a diﬀerence in 
outcomes. 
17.3. Sta;s;cal Analysis: See above. 
17.4. Data Integrity:  
Data will be entered by a member of the study team and accuracy of data entry 
veriﬁed by a second team member. We will implement a team approach to analysis, 
meaning that community health worker interven;onists and members of the study 
team including the PI will jointly analyze and interpret results.  
18. Health InformaMon and Privacy Compliance 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health informa;on and 
therefore assert HIPAA does not apply.   
☒ I am reques;ng that all research par;cipants sign a HIPCO approved HIPAA 
Disclosure Authoriza;on to par;cipate in the research (either the standalone 
form or the combined consent and HIPAA Authoriza;on). 
☐ I am reques;ng the IRB to approve a Waiver or an altera;on of research 
par;cipant authoriza;on to par;cipate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are reques;ng use of the 
authoriza;on language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authoriza;on.  Note: External IRB must be serving as 
the privacy board for this op;on. 
18.1.
Iden;fy the source of Private Health Informa;on you will be using for your 
research (Check all that apply)   
☐ I will use the Informa;cs Consul;ng Services (ICS) available through CTSI (also 
referred to as the University's Informa;on Exchange (IE) or data shelter) to pull 
records for me 
☒ I will collect informa;on directly from research par;cipants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoie;c 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
Page 
 of 
 
Template Revised On: 09/01/2019
31
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another ins;tu;on  
☐ Other.  Describe:  
18.2.
Explain how you will ensure that only records of pa;ents who have agreed to have 
their informa;on used for research will be reviewed. 
All data collected will be self report. 
18.3.Approximate number of records required for review: 
NA. All data collected will be self report. 
18.4.
Please describe how you will communicate with research par;cipants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communica;on with 
research par;cipants. 
☐ Communica;on with research par;cipants will take place in the course of 
treatment, through MyChart, or other similar forms of communica;on used 
with pa;ents receiving treatment.  
☒ Communica;on with research par;cipants will take place outside of treatment 
selngs. If this box is selected, please describe the type of communica;on and 
how it will be received by par;cipants. 
 
Ini;al recruitment, scheduling and interven;on visit reminders will occur 
through telephone communica;on. Main study interac;ons and data collec;on 
will be in person.  
18.5.Access to par;cipants 
NA 
18.6. Loca;on(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Informa;on Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoie;c Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In REDCap (recap.ahc.umn.edu)  
Page 
 of 
 
Template Revised On: 09/01/2019
32
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
 ☒ Store 
☒ Analyze 
☐ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In an AHC-IS supported server. Provide folder path, loca;on of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
PI device # 20201033 
 ☒ Store 
☐ Analyze 
☐ Share 
☐ Other. 
Indicate if data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smarhorm (iPhone or Android devices) that you have not 
already iden;ﬁed in the preceding ques;ons 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“ﬂash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
18.7. Consultants. Vendors. Third Par;es. 
NA. No data sharing agreement is needed. 
18.8.Links to iden;ﬁable data: 
De-iden;ﬁed data (immediately deiden;ﬁed) will be stored in a secure, UMN administered 
RedCAP database. Study documents that include iden;fying informa;on will be stored in 
private, password protected, encrypted project folders hosted by the UMN server in the UMN 
Page 
 of 
 
Template Revised On: 09/01/2019
33
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Box domain. Contact informa;on for par;cipants who agree to future contact and 
par;cipa;on will be stored in UMN Box folders. There will be a single document linking 
iden;fying informa;on with study IDs stored in the UMN Box folder. Deiden;ﬁed informa;on 
will be released to WellShare Interna;onal Community Health Worker Interven;onists, as 
they will par;cipate in data analysis and interpreta;on. No other informa;on will be released 
any addi;onal par;es without the wriUen consent of the study par;cipant. 
18.9.
Sharing of Data with Research Team Members.  
Data will be shared via UMN Box and REdCAP. 
18.10. Storage and Disposal of Paper Documents:  
All paper documents will be locked in a secure ﬁle cabinet in a locked research 
oﬃce and kept for at least 3 years aper study comple;on.  
19. ConﬁdenMality 
19.1. Data Security: 
Conﬁden;ality will be maintained by iden;fying each subject on research records with 
only a study number. Therefore, no hard copy forms will contain iden;ﬁable par;cipant 
data. Data will be stored in a secure, University of Minnesota administered, RedCAP 
database. Electronic study documents that include iden;fying informa;on will be stored in 
private, password protected, encrypted project folders hosted by the University of 
Minnesota server in the University of Minnesota Box domain. Examples of this type of 
document are ﬁles that contain par;cipant name and contact informa;on, or records that 
link the par;cipant ID to the par;cipant name. To minimize the likelihood of a breach of 
privacy or conﬁden;ality, only deiden;ﬁed informa;on will be released to WellShare 
Interna;onal Community Health Worker Interven;onists, as they will par;cipate in data 
analysis and interpreta;on. No other informa;on will be released any addi;onal par;es 
without the wriUen consent of the study par;cipant. All study team members will be 
required to complete the CITI course in the Protec;on of Human Research Subjects. Data 
will be collected with youth and the maternal and paternal par;cipants separately to 
ensure privacy unless an otherwise preference is indicated.  
To help protect the privacy of par;cipants, the Na;onal Ins;tutes of Health has granted a 
Cer;ﬁcate of Conﬁden;ality for this study. The researchers can use this Cer;ﬁcate legally to refuse 
to disclose informa;on that may iden;fy the par;cipant in any federal, state, or local civil, 
criminal, administra;ve, legisla;ve, or other proceedings, for example, if there is a court 
Page 
 of 
 
Template Revised On: 09/01/2019
34
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
subpoena. The researchers will use the Cer;ﬁcate to resist any demands for informa;on that 
would iden;fy the par;cipants, except as explained below. 
The Cer;ﬁcate does not prevent a researcher from repor;ng informa;on learned in research when 
required by other state or federal laws, such as mandatory reports to local health authori;es for 
abuse or neglect of children/vulnerable adults, or informa;on to the Food and Drug 
Administra;on (FDA) when required in an FDA audit.  However, the Cer;ﬁcate limits the 
researcher from disclosing such informa;on in follow up civil, criminal, legisla;ve or administra;ve 
legal proceedings if the informa;on was created or compiled for purposes of the research.   
The Cer;ﬁcate of Conﬁden;ality does not prevent the par;cipant or a member of their family 
from voluntarily releasing informa;on about themselves or their involvement in this research. If an 
insurer, medical care provider, or other person obtains their wriUen consent to receive research 
informa;on, then the researchers will not use the Cer;ﬁcate to withhold that informa;on.   
20. Provisions to Monitor the Data to Ensure the Safety of ParMcipants 
There is a poten;al risk for psychological or social discomfort when comple;ng surveys 
and aUending group interven;on mee;ngs. This risk is considered minimal; the alterna;ve 
is to not answer the ques;ons or to not par;cipate in the group conversa;ons that elicit 
discomfort. 
20.1. Data Integrity Monitoring.  
20.1.1.
Considering the study ra;onale, popula;on, procedures and the risk: beneﬁt proﬁle, the 
overall risk level for par;cipa;on in this study is classiﬁed as minimal. The Data Safety 
Monitoring Plan (DSMP) for this pilot award will focus on close monitoring by the principal 
inves;gator (PI) in conjunc;on with project advisors, who will be available to review and 
recommend appropriate ac;on regarding individual reports of serious adverse events, 
adverse events, and other safety issues. The Community Advisory Board and community-
based organiza;onal partners will also serve as resources if incidental ﬁndings emerge. 
The PI will have the primary responsibility to monitor this study.  
20.1.2.NA 
20.1.3.
Principal Inves;gator (PI). Dr. Sarah Hoﬀman, will have the primary responsibility to 
monitor this study. The PI will review data on such aspects as par;cipant enrollment, study 
procedures, forms comple;on, data quality, losses to follow-up, and other measures of 
adherence to the protocol.  
20.1.4.
See above. 
 
20.1.5.
Page 
 of 
 
Template Revised On: 09/01/2019
35
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
The study team does not plan to implement a data safety monitoring board or an 
independent safety monitor at this ;me due to: 1) an;cipated low risk of harm to 
par;cipants; 2) clinical trial designa;on (Phase 1); and 3) the mentor team involvement in 
suppor;ng the candidate (PI) to protect the safety of research par;cipants and the validity 
and integrity of study data. 
20.1.6.NA 
20.2. Data Safety Monitoring.  
20.2.1.
Considering the study ra;onale, popula;on, procedures, and the risk: beneﬁt proﬁle, 
the overall risk level for par;cipa;on in this study is minimal. The DSMP for this pilot 
award will focus on close monitoring by the PI in conjunc;on with project advisors, 
who will be available to review and recommend appropriate ac;on regarding 
individual reports of serious adverse events, adverse events, and other safety issues. 
The community advisory board and community organiza;onal partners will also 
serve as resources if incidental ﬁndings emerge. The PI will review all possible and 
real events, and seek recommenda;ons from the study team in real ;me regarding 
all adverse events. The PI will be responsible for submilng necessary reports 
concerning adverse events to the University of Minnesota IRB within the required 
repor;ng ;meframes. 
20.2.2.
Reports of par;cipant distress. 
20.2.3.
At study visits and via telephone calls with par;cipants.  
20.2.4.
Data collected pre/post interven;on. Safety data monitoring beings with pre-
interven;on data collec;on.  
20.2.5.
NA 
20.2.6.
The study PI. 
20.2.7.
The PI will rou;nely review study ac;vi;es and data collec;on weekly.  
20.2.8.
Qualita;ve self report. Sta;s;cal tests not applicable.  
Page 
 of 
 
Template Revised On: 09/01/2019
36
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
20.2.9.
Depending on context surrounding data collec;on, a covid-19 posi;ve test of a 
par;cipant and or study team member would temporarily suspend research 
procedures. 
21. CompensaMon for Research-Related Injury 
21.1. Compensa;on for Research-Related Injury:  
NA 
21.2. Contract Language:  
NA 
22. Consent Process 
22.1. Consent Process (when consent will be obtained):  
Consent in phase 1 will take place via phone. Consent in phase 2 will take place in 
person, in par;cipant homes. 
22.1.1.
Par;cipants will be contacted by telephone ini;ally. If they are interested in possible 
enrollment, a visit will be scheduled in the par;cipants home to more fully explain 
study procedures, conduct consent, and enrollment. The period between the ini;ally 
phone call and obtaining consent will vary based on when the community health 
worker interven;onist and the family are able to ﬁnd a mutual ;me in their 
schedules.   
22.1.2.
In phase 1 the parents of poten;al youth focus group parents of poten;al 
par;cipants will be contacted by phone. The focus group will be explained in detail 
to the parent. Verbal consent for par;cipa;on will be requested from one caregiver. 
The Community Health Worker interven;onist will then contact the par;cipant to 
assess willingness to par;cipate. The assent form will be read to the youth over the 
phone. If the par;cipant agrees, the Community Health Worker interven;onist will 
invite the youth to the focus group. Assent will be reiterated with the group at the 
start of the focus group. 
In phase 2 poten;al par;cipants will be contacted by phone by a Karen community 
health worker interven;onist. A brief descrip;on of the project will be provided over 
the phone. If members of the family express interest, an in-person mee;ng will be 
scheduled in the poten;al par;cipant’s home or a preferred alterna;ve loca;on. 
During the in-person mee;ng, par;cipants who conﬁrm interest in study 
Page 
 of 
 
Template Revised On: 09/01/2019
37
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
par;cipa;on and who are qualiﬁed to par;cipate will be given a detailed descrip;on 
of the study ac;vi;es. Caregivers and youth will be given a copy of the informed 
consent/assent forms printed in English and Karen language where study 
requirements, procedures, and risks and beneﬁts are detailed. Explana;ons will be 
given (or in some cases the form may be read aloud) in the preferred language of 
prospec;ve par;cipants. Informed consent will be obtained by the delegate of the PI 
who is also approved by the IRB to obtain informed consent and youth assent on the 
project. The informed consent form will be signed in the presence of another person 
and par;cipants will be given the opportunity to ask ques;ons about the procedures 
outlined in the informed consent form. A copy of the IRB-approved informed 
consent document and HIPAA agreement will be given to the par;cipant in their 
preferred language. Adult par;cipants will consent for themselves, as well as grant 
permission for youth under 18 to be involved in the project. 
We will request one signed parental permission and one verbal parental permission 
for all two parent households. The same protocol was followed with Karen study 
par;cipants in earlier study phases and aligned with Karen norms and values. 
Typically, it was the mother who provided wriUen permission. Following the consent 
process with adult (parent) par;cipants, details of the study will be provided to 
youth in a similar manner (read or verbal) and in their preferred language, English, 
Karen, or a hybrid. Youth will have an opportunity to ask ques;ons and discuss 
par;cipa;on with their families prior to assen;ng. Youth assent will take place in the 
presence of the signing maternal/paternal par;cipant in the study. In the 
circumstance that a parent consents to par;cipate, but the youth does not assent, 
the family will be considered ineligible for par;cipa;on. 
Ongoing consent to par;cipa;on will occur at the start of each interven;on session.  
Par;cipants will be given a copy of their signed and dated consent/assent forms. 
22.2. Waiver or Altera;on of Consent Process (when consent will not be obtained, 
required informa;on will not be disclosed, or the research involves decep;on):  
NA 
22.3. Waiver of WriUen/Signed Documenta;on of Consent (when wriUen/signed consent 
will not be obtained):  
NA 
22.4. Non-English Speaking Par;cipants:  
Karen 
●
All consent documents will be transcribed in the Karen language. Community 
health worker interven;onists are themselves Karen and will conduct 
interven;on sessions in the Karen language. 
Page 
 of 
 
Template Revised On: 09/01/2019
38
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
●
When the PI is present for study interac;ons, the community health worker 
interven;onists (who also func;on in their roles as expert interpreters) will 
interpret the interac;ons. Otherwise, the study will be conducted in the 
language of par;cipants and without interpreta;on. 
●
Enrollment of non-English speakers is expected.  
22.5. Par;cipants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
22.5.1.Adult study par;cipants will iden;fy their children 11-18 who are eligible and 
interested in study par;cipa;on.  
22.5.1.1.
22.5.1.2.NA 
22.5.1.3.See above. Consent will be aUained from one parent verbally (phase 
1); and both parents when available, one verbal and one signed (phase 2).  
22.5.1.4.For single parent households where the other parent is living 
separately or out of state, we will obtain from consent only from the 
primary caregiver.  
22.5.2.NA 
22.5.3.All. 
22.5.4.Youth assent will be documented in the study record. 
22.6. Cogni;vely Impaired Adults, or adults with ﬂuctua;ng or diminished capacity to 
consent: NA 
22.7. Adults Unable to Consent: NA 
23. Seing 
23.1. Research Sites: Par;cipants will be asked their preference of in person study visits or 
Zoom study visits. Due to the Covid pandemic, we are altering our ini;al plan for 
study interac;ons to be exclusively home-based. One CHWI will interact with 
par;cipants preferring an in person op;on in their homes as planned. The second 
CHWI will deliver the interven;on via Zoom sessions. The focus group will take place 
in a loca;on that is accessible and known to the community. We are planning for in 
person focus groups. Zoom sessions and in person sessions will be video and audio 
recorded for ﬁdelity monitoring and coaching purposes. 
Youth L2B interven;on sessions will be delivered in a group format at the Knyaw 
Bap;st Church.  
23.1.1.
Page 
 of 
 
Template Revised On: 09/01/2019
39
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
Par;cipants will be recruited from an exis;ng cohort that par;cipated in earlier 
phases of the study. All par;cipants gave permission to the study team to contact 
them with further opportuni;es to par;cipate in the project.  
23.1.2.
In par;cipant homes or via Zoom. Home-based services is a model of care familiar to 
the refugee community in Minnesota. WellShare Interna;onal (our community 
partner) provides home-based services rou;nely in their opera;ons. During the 
pandemic it was typical for organiza;ons to oﬀer tele-health appointments with 
clients. Community members are now more accustomed to this plahorm and may 
prefer this approach. Our ini;al phases of implementa;on with youth demonstrated 
that a group format would be more engaging, thus we are returning to the original 
model of interven;on delivery for the Learning to Breathe interven;on. 
23.1.3.
A community advisory board developed in early phases of the study will con;nue to 
provide input on the adapta;on of the interven;on and study procedures. The 
community advisory board is comprised of representa;ves from key community 
organiza;ons serving the refugee community in Minnesota.  
23.1.4.
23.1.4.1. NA 
23.1.4.2.NA 
23.2. Interna;onal Research: NA 
23.3. Community Based Par;cipatory Research:  
23.3.1.WellShare Interna;onal is a primary study partner and will be involved at all 
stages of the research.  
23.3.2.Community Health Workers will compete CITI training. Ongoing and regular 
discussions about human protec;ons, privacy, conﬁden;ality, and autonomy 
will take place during weekly study team mee;ngs. Community health worker 
interven;onists will be listed as study team members on the IRB submission. 
23.3.3.See suppor;ng documents in Ethos. 
24. MulM-Site Research 
NA 
25. CoordinaMng Center Research 
NA 
26. Resources Available 
Page 
 of 
 
Template Revised On: 09/01/2019
40
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
26.1. Resources Available:  
26.1.1.At this point we do not have a student inves;gator involved in the project. 
26.1.2.Our sample is very small given that the focus of this phase of the feasibility 
trial is reﬁning the CBPR approach, interven;onist training, and ﬁdelity 
monitoring procedures. The ability to recruit the target sample size is feasible. 
We have access to 96 Karen families through an exis;ng cohort. We are 
targe;ng 10% of those families for the current study phase.  
26.1.3.The PI will allocate at least 10 hours per week to the project. Community 
health worker interven;onist ;me will vary based on the phase of the study. 
Administra;ve support at WellShare Interna;onal has allocated 1-4 hours per 
month for oversight of ac;vi;es. 
26.1.4.
The University of Minnesota (UMN) has an outstanding research reputa;on and is 
ranked in the top 25 research ins;tu;ons in the United States by the Center for 
Measuring University Performance at Arizona State University. Both a state land-
grant university and Minnesota’s only research university; it is one of the leading 
recipients of federal research awards in the U.S. In ﬁscal year 2017, the University 
received more than $744 million in grant and contract awards from federal, state, 
and private sources and ranked in the top 10 of all public and private research 
universi;es. The University conducts 98 percent of all sponsored academic 
research in Minnesota. The University is one of the most comprehensive 
universi;es in the United States with more than 370 ﬁelds of study and over 
65,000 students. The Graduate School oﬀers more than 150 masters and doctoral 
degree programs covering virtually every area of academic inquiry. The wide 
breadth of program oﬀerings provides graduate students with mul;ple 
opportuni;es for interdisciplinary study.  
The Academic Health Center (AHC) is home to six colleges and schools, and more 
than 90 centers, ins;tutes, and hospitals and clinics. About 70 percent of 
Minnesota’s health care providers train through the AHC, including doctors, nurses, 
den;sts, pharmacists, public health workers, and veterinarians. Innova;ons for 
pa;ent care happen because of inter-professional collabora;on across the health 
sciences.  
The Clinical and TranslaMonal Science InsMtute (CTSI; UL1TR002494) is building an 
integrated network of research services and support at the University of Minnesota 
that provides comprehensive support for the en;re spectrum of clinical and 
transla;onal research through a single point of entry. High quality and cost-
Page 
 of 
 
Template Revised On: 09/01/2019
41
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
eﬀec;ve research services include informa;cs tools, expert consulta;ons, 
biosta;s;cal support, regulatory support, and clinical research facili;es. 
CTSI’s Community Engagement to Advance Research and Community Health 
(CEARCH) oﬃce provides an infrastructure for community groups and University-
based researchers to work together to address health issues in ways that are truly 
relevant to the community.  
Established in 1909, the mission of the UMN School of Nursing is to generate 
knowledge and prepare nurse leaders who will create, lead, and par;cipate in 
holis;c eﬀorts to improve the health of all people within the context of their 
environments. The school has two loca;ons: one in the heart of the Twin Ci;es of 
Minneapolis and St. Paul, and the second in Rochester, home of the Mayo Clinic. 
Original scholarly inquiry is at the core of the rich synergy of research, educa;on 
and prac;ce at the School of Nursing. Opportuni;es for collabora;ve research 
abound with nursing colleagues, colleagues from other disciplines at the 
University of Minnesota’s renowned Academic Health Center (AHC), in other 
academic areas throughout the university, and with community partners in this 
progressive, health-oriented community. Focal areas of research in the School of 
Nursing include: Health Promo;on among Vulnerable Popula;ons; Preven;on 
and Management of Chronic Health Condi;ons; Symptom Management; Health/
Nursing Informa;cs and Systems Improvement. In the School of Nursing, the 
Center for Child and Family Health Promo/on Research (CCFHPR) mission is to 
improve the health of infants, children, adolescents, parents, and families 
through the development and dissemina;on of evidence-based knowledge of 
eﬀec;ve interven;ons and best prac;ces in primary and secondary preven;on.  
26.1.5.See descrip;on of resources described in Foreseeable Risks 13.2. We will 
ensure readily available resources in the case that par;cipants experience 
unan;cipated consequences of the research. 
26.1.6.In this phase we are collabora;vely developing and reﬁning the study protocol 
and research procedures, WellShare interven;onists will be involved in the 
development of these process. The PI will have weekly mee;ngs with the 
interven;onists where we will discuss all aspects of research ac;vi;es.  
27. References 
1. United Na;ons High Commissioner for Refugees. (2018). Forced displacement at record 68.5 
million. Retrieved from hUps://www.unhcr.org/en-us/news/stories/2018/6/5b222c494/forced-
displacement-record-685-million.html  
2. American Psychiatric Associa;on. (2000). Diagnos/c and sta/s/cal manual of mental disorders 
(4th ed., text rev.). Washington, DC: Author.  
Page 
 of 
 
Template Revised On: 09/01/2019
42
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
3. United Na;ons General Assembly. (1984). Conven;on against Torture and Other Cruel, 
Inhuman or Degrading Treatment or Punishment. Retrieved from hUp://www.un.org/documents/
ga/res/39/a39r046.htm  
4. Sangalang, C. C., & Vang, C. (2017). Intergenera;onal trauma in refugee families: A systema;c 
review. Journal of Immigrant and Minority Health, 19(3), 745-754. 
5. Danieli, Y., Norris, F. H., & Engdahl, B. (2016). Mul;genera;onal legacies of trauma: Modeling 
the what and how of transmission. American Journal of Orthopsychiatry, 86(6), 639-651. hUp://
dx.doi.org/10.1037/ort0000145 
6. O’Neill, L., Fraser, T., Kitchenham, A., & McDonald, V. (2018). Hidden burdens: A review of 
intergenera;onal, historical and complex trauma, implica;ons for indigenous families. Journal of 
Child & Adolescent Trauma, 11(2), 173-186. 
7. Wieling, E. (2018). Family Interven;ons for Popula;ons Exposed to Trauma;c Stress Related to 
War and Violence. Journal of Marital and Family Therapy, 44(2), 189-192. 
8. Daud, A., Skoglund, E., & Rydelius, P. A. (2005). Children in families of torture vic;ms: 
Transgenera;onal transmission of parents’ trauma;c experiences to their children. Int Journal of 
Social Welfare, 14(1), 23-32. 
9. Dalgaard, N. T., Todd, B. K., Daniel, S. I., & Montgomery, E. (2016). The transmission of trauma 
in refugee families: Associa;ons between intra-family trauma communica;on style, children’s 
aUachment security and psychosocial adjustment. A+achment & Human Development, 18(1), 
69-89. 
10. Daud, A., af Klinteberg, B., & Rydelius, P. A. (2008). Resilience and vulnerability among refugee 
children of trauma;zed and non-trauma;zed parents. Child and Adolescent Psychiatry and Mental 
Health, 2(1), 7. 
11. Montgomery, E. (2004). Tortured families: A coordinated management of meaning analysis. 
Family Process, 43(3), 349-371. 
12. Sangalang, C. C., Jager, J., & Harachi, T. W. (2017). Eﬀects of maternal trauma;c distress on 
family func;oning and child mental health: An examina;on of Southeast Asian refugee families in 
the US. Social Science & Medicine, 184, 178-186. 
13. Van Ee, E., Kleber, R. J., & Mooren, T. (2012). War trauma lingers on: Associa;ons between 
maternal posUrauma;c stress disorder, parent–child interac;on, and child development. Inf Ment 
Hlth, 33(5), 459-468. 
14. Burchert, S., Stammel, N., & Knaevelsrud, C. (2017). Transgenera;onal trauma in a post-
conﬂict selng: Eﬀects on oﬀspring PTSS/PTSD and oﬀspring vulnerability in Cambodian families. 
Psych Res, 254, 151-157. 
15. East, P. L., Gahagan, S., & Al-Delaimy, W. K. (2018). The Impact of Refugee Mothers’ Trauma, 
PosUrauma;c Stress, and Depression on Their Children’s Adjustment. J of Imm and Min Hlth, 
20(2), 271-282. 
16. Posselt, M., Galletly, C., de Crespigny, C., & Procter, N. (2014). Mental health and drug and 
alcohol comorbidity in young people of refugee background: a review of the literature. Mental 
Health and Substance Use, 7(1), 19-30. 
Page 
 of 
 
Template Revised On: 09/01/2019
43
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
17. Sowey, H. (2005). Are refugees at increased risk of substance misuse. Sydney: Drug and 
Alcohol Mul;cultural Educa;on Centre. 
18. Posselt, M., Procter, N., Galletly, C., & De Crespigny, C. (2015). Ae;ology of coexis;ng mental 
health and alcohol and other drug disorders: perspec;ves of refugee youth and service providers. 
Australian Psychologist, 50(2), 130-140. 
19. Rossiter, M. J., & Rossiter, K. R. (2009). Diamonds in the rough: Bridging gaps in supports for 
at-risk immigrant and refugee youth. Journal of Interna/onal Migra/on and Integra/on, 10(4), 
409. 
20. Goodrum, N. M., Chan, W. Y., & Latzman, R. D. (2015). Gang Involvement among Immigrant 
and Refugee Youth: A Developmental Ecological Systems Approach. Interna/onal Journal of 
Developmental Science, 9(3, 4), 125-134. 
21. Van Ngo, H., Calhoun, A., Worthington, C., Pyrch, T., & Este, D. (2017). The unravelling of 
iden;;es and belonging: Criminal gang involvement of youth from immigrant families. Journal of 
Interna/onal Migra/on and Integra/on, 18(1), 63-84. 
22. Hoﬀman, S. J., Vukovich, M. M., Gewirtz, A. M., Fulkerson, J. A., Robertson, C. R., & Gaugler, J. 
E. Mechanisms explaining the rela;onship between maternal torture exposure and youth 
adjustment in reseUled refugees: A pilot examina;on of genera;onal trauma through moderated 
media;on. Under review at Journal of Immigrant and Minority Health  
23. Hoﬀman, S. J., Vukovich, M. M., Peden-McAlpine, C., Robertson, C. L., Wilk, K., & Gaugler, J. E. 
Physical narra;ves of trauma. Under review at Qualita/ve Health Research. 
24. Lehrner, A., & Yehuda, R. (2018). Trauma across genera;ons and paths to adapta;on and 
resilience. Psychological Trauma: Theory, Research, Prac/ce, and Policy, 10(1), 22. 
25. Yehuda, R., Halligan, S. L., & Grossman, R. (2001). Childhood trauma and risk for PTSD: 
rela;onship to intergenera;onal eﬀects of trauma, parental PTSD, and cor;sol excre;on. 
Development and psychopathology, 13(3), 733-753. 
26. Brink, D. R., Shannon, P. J., & Vinson, G. A. (2015). Valida;on of a brief mental health screener 
for Karen 
refugees in primary care. Family prac/ce, 33(1), 107-111. 
27. Olson, D. (2011). FACES IV and the circumplex model: Valida;on study. J Marr & Fam Ther, 
37(1), 64-80. 
28. Goodman R, Meltzer H, Bailey V (1998) The Strengths and Diﬃcul;es Ques;onnaire: A pilot 
study on the 
validity of the self-report version. European Child and Adolescent Psychiatry, 7, 125-130. 
29. Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and 
emo;on regula;on: The development and ini;al valida;on of the Cogni;ve and Aﬀec;ve 
Mindfulness Scale-Revised (CAMS-R). Journal of psychopathology and Behavioral Assessment, 
29(3), 177. 
30.. Grant, M., Salsman, N. L., & Berking, M. (2018). The assessment of successful emo;on 
regula;on skills use: Development and valida;on of an English version of the Emo;on Regula;on 
Skills Ques;onnaire. PloS one, 13(10), e0205095. 
Page 
 of 
 
Template Revised On: 09/01/2019
44
45

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: MBI Interven;on with war-aﬀected families 
VERSION DATE:  3/2/2022 v6 
31. Cohen, S., & Hoberman, H. (1983). Posi;ve events and social supports as buﬀers of life change 
stress. Journal of Applied Social Psychology, 13, 99-125.  Journal of Applied Social Psychology, 13, 
99-125. 
32. Gewirtz, A. H., Pinna, K. L., Hanson, S. K., & Brockberg, D. (2014). Promo;ng paren;ng to 
support reintegra;ng military families: Aper deployment, adap;ve paren;ng tools. Psychological 
services, 11(1), 31. 
33. Gewirtz, A. H., DeGarmo, D. S., & Zamir, O. (2018). Aper deployment, adap;ve paren;ng 
tools: 1-year outcomes of an evidence-based paren;ng program for military families following 
deployment. Preven/on Science, 19(4), 589-599. 
34. Gewirtz, A., & Davis, L. (2014). Paren;ng prac;ces and emo;on regula;on in Na;onal Guard 
and Reserve families: Early ﬁndings from the Aper Deployment Adap;ve Paren;ng Tools/ADAPT 
study. In Military deployment and its consequences for families (pp. 111-131). Springer, New York, 
NY. 
35. Zhang, N., Zhang, J., & Gewirtz, A. H. (2019). Do less mindful mothers show beUer paren;ng 
via improvements in trait mindfulness following a military parent training program?. Fron/ers in 
Psychology, 10, 909. 
36. Zhang, N., Rudi, J. H., Zamir, O., & Gewirtz, A. H. (2018). Parent engagement in online 
mindfulness exercises within a parent training program for post-deployed military families. 
Mindfulness, 9(3), 725-736. 
37. Bluth, K., Campo, R. A., Pruteanu-Malinici, S., Reams, A., Mullarkey, M., & Broderick, P. C. 
(2016). A school-based mindfulness pilot study for ethnically diverse at-risk adolescents. 
Mindfulness, 7(1), 90-104. 
38. Broderick, P. C., & Metz, S. (2009). Learning to BREATHE: A pilot trial of a mindfulness 
curriculum for adolescents. Advances in school mental health promo/on, 2(1), 35-46. 
39. Metz, S. M., Frank, J. L., Reibel, D., Cantrell, T., Sanders, R., & Broderick, P. C. (2013). The 
eﬀec;veness of the learning to BREATHE program on adolescent emo;on regula;on. Research in 
Human Development, 10(3), 252-272. 
40. Broderick, P. C., & Frank, J. L. (2014). Learning to BREATHE: An interven;on to foster 
mindfulness in adolescence. New direc/ons for youth development, 2014(142), 31-44. 
41. Bluth, K., Campo, R. A., Pruteanu-Malinici, S., Reams, A., Mullarkey, M., & Broderick, P. C. 
(2016). A school-based mindfulness pilot study for ethnically diverse at-risk adolescents. 
Mindfulness, 7(1), 90-104. 
     
Page 
 of 
 
Template Revised On: 09/01/2019
45
45