Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial
Phase: NA
Conditions: Stress, Psychological, Stress, Physiological, Anxiety, Depression
Sponsor: University of Massachusetts, Amherst

 
 
 
 
 
 
 
 
 
 
 
A Protocol of Procedures and Operations  
 
 

i 
 
Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered 
Preventative Intervention for Immigrants: A Randomized Controlled 
Feasibility Trial 
 
 
 
 
 
 
 
Principal Investigator 
Kalpana Poudel-Tandukar, Ph.D., MPH, MPHC, CGM 
Assistant Professor 
College of Nursing 
University of Massachusetts Amherst 
 
 
 
 
 
Funded by: 
National Institute of Mental Health 
National Institutes of Health 
R34MH118396 
NCT04453709 
March 25, 2021 
 

ii 
 
 
TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE .......................................................................................................... i 
TABLE OF CONTENTS ............................................................................................................ iii 
PRÉCIS ......................................................................................................................................... iii 
Study Title .................................................................................................................................. iii 
    Objectives……………………………………………………………………………………...iii 
 
Design and Outcomes ................................................................................................................ iv 
Interventions and Duration ........................................................................................................ iv 
Sample Size and Population........................................................................................................ v 
STUDY TEAM ROSTER............................................................................................................. 1 
Investigators Name…. . ............................................................................................................ 1 
Investigators Responsibilities ..................................................................................................... 3 
PARTICIPATING STUDY SITES ............................................................................................. 7 
1 
STUDY OBJECTIVES ......................................................................................................... 7 
1.1 
Hypothesis....................................................................................................................... 7 
1.2 
Objectives ....................................................................................................................... 7 
2 
BACKGROUND AND RATIONALE ................................................................................ 8 
2.1 
Background  .................................................................................................................... 8 
2.2 
Study Rationale ............................................................................................................... 9 
3 
STUDY DESIGN ................................................................................................................. 10 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 13 
4.1 
Inclusion Criteria .......................................................................................................... 13 
4.2 
Exclusion Criteria ......................................................................................................... 13 
4.3 
Study Enrollment Procedures ....................................................................................... 14 
5 
STUDY INTERVENTIONS .............................................................................................. 17 
5.1 
Interventions, Administration, and Duration ................................................................ 17 
5.2 
Adherence Assessment ................................................................................................. 19 
6 
STUDY PROCEDURES .................................................................................................... 20 
6.1 
Schedule of Evaluations ................................................................................................ 21 

 
ii 
6.2 
Description of Evaluations ............................................................................................ 22 
6.2.1 Screening Evaluation ................................................................................................ 22 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 25 
6.2.3 Follow-up Visits........................................................................................................ 28 
6.2.4 Completion/Final Evaluation .................................................................................... 29 
7 
SAFETY ASSESSMENTS ................................................................................................. 30 
7.1 
Adverse Events and Serious Adverse Events ............................................................... 30 
7.2 
Independent Safety Monitoring .................................................................................... 32 
7.3       Potential Risks and Mitigation Strategies...…………………………………………..34 
 
8 
INTERVENTION DISCONTINUATION........................................................................ 35 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 36 
9.1 
Sample Size and Randomization .................................................................................. 36 
9.2 
Data Analyses ............................................................................................................... 37 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 41 
10.1 
Data Collection Forms .................................................................................................. 41 
10.2 
Data Management, Analysis, and Quality Assurance ................................................... 43 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 49 
11.1 
Institutional Review Board (IRB) Review .................................................................... 49 
11.2 
Informed Consent Forms .............................................................................................. 49 
11.3 
Participant Confidentiality ............................................................................................ 49 
11.4 
Confidentiality Limits ...................................................................................................... 51 
11.5     Study Discontinuation………………………………………………………………...52 
 
12 ETHICAL CONSIDERATIONS ....................................................................................... 52 
13 PUBLICATION OF RESEARCH FINDINGS ................................................................ 52 
14 REFERENCES .................................................................................................................... 53 
 
 
 
 
 

 
iii 
PRÉCIS 
Study Title  
Reducing stress, anxiety, and depressive symptoms via a family-centered preventative 
intervention for immigrants: A randomized controlled feasibility trial  
 
Objective 
The current study aims to pilot test the feasibility and acceptability of Problem Management 
Plus for Immigrants (PMP-I) among Bhutanese immigrants 18 years and older living in 
Massachusetts.  
 
Aim 1: Adapt and culturally modify PMP to develop PMP-I as a family-based 
preventative intervention.  
a) Develop a training guide and intervention curriculum;  
b) Obtain iterative feedback about the format, ease of use, and implementation barriers from 
participants, facilitators, and community members. 
 
Aim 2: Test the feasibility, acceptability, and preliminary outcomes of PMP-I with 
trained community facilitators.  
a) Assess i) recruitment, session attendance, and retention rates and program acceptability 
using checklists from participants; ii) feasibility of measures for assessing 
inclusion/exclusion, the fidelity of intervention delivery, mediators of response, and 
outcomes using checklists from facilitators; and iii) barriers and facilitators of intervention 
using interview and focus group discussion with participants and facilitators.  
b) Test preliminary effects of PMP-I vs. talk program with community support services 
pamphlets (CSS) using a small randomized pilot trial (N=116 families; 58 families per 
intervention and control) on perceived stress, anxiety and depressive symptoms (primary), 
physiological stress assessed in hair cortisol (secondary), and self-efficacy and coping 
strategy, family wellbeing, and social networking (targets), with assessments at baseline, 
post-intervention, and 3-month post-intervention. 
c) Evaluate the relationships between targets and outcomes and explore mediators (e.g., 
coping) of intervention-outcome relation. 

 
iv 
 
Design and Outcomes   
Study design:  
This mixed-methods study will incorporate a two-arm randomized controlled feasibility trial and 
qualitative evaluation of PMP-I intervention's acceptability to a range of stakeholders. 
Allocation: Randomized 
Intervention Model: Parallel Assignment 
Masking: None 
Primary purpose: Prevention 
 
Outcomes: 
Primary Outcome 
Perceived stress: The 10-item Cohen Perceived Stress Scale (PSS)1 will be used to assess 
perceived stress at baseline, post-intervention, and three-month post-intervention. The PSS uses a 
5-point Likert scale (ranging from 0, “never” to 4, “very often”) to assess psychological stress 
experienced during the past month, including the extent to which situations felt unpredictable, 
uncomfortable, and overwhelming.  
 
Anxiety and Depressive symptoms: The Hopkins Symptom Checklist-25 (HSCL-25)2 will be 
used to measure anxiety and depressive symptoms experienced over the past month at baseline, 
post-intervention, and three-month post-intervention. It is composed of a 10-item subscale for 
anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 
(not at all) to 4 (extremely).  
 
Secondary outcome 
Physiological stress: Cortisol hair-test (average hormone levels over the past three months) will 
be used as a biomarker to measure physiological stress. Neuroendocrine indicators, such as 
cortisol, are effective stress biomarkers because they are the first to respond to a given stressor 
and coordinate the physiological response of other bio-physiological systems.  
 

 
v 
Interventions and Duration  
Study Arms: 
Experimental: Problem Management Plus for Immigrants (PMP-I) at family settings 
Active Comparator: Talk program with Community Support Service Pamphlet (CSS) 
Assessment: 
 Baseline, Post-Intervention, and 3-month Post-Intervention 
 
Intervention: 
PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation, and 
problem-solving (90 minutes), breathing and yoga intervention (90 minutes) in a family 
setting. PMP-I will use a structured approach, including once a week, face-to-face sessions, 
breathing, yoga practice, homework that includes recording activities, rebuilding individual 
skills, or learning new skills to reduce stress.  
1. Managing Stress: Breathing and yoga practices, stress-management sessions, and 
behavioral activation exercises to strengthen positive coping strategies. 
2. Managing Problems: Practice exercises to identify the problems, develop solutions, and 
plan a strategy to carry out those solutions. 
3. Behavior Activation: Communication skill sessions and practice exercises to identify and 
carry out pleasant tasks. 
4. Strengthening Social Support: Social skills session and practice exercise to identify 
social support. 
5. Staying Well:  Make a plan that helps to create a supportive family environment. 
 
Sample Size and Population  
This study will be conducted among 226 Bhutanese adults settled in Massachusetts.

 
1 
STUDY TEAM ROSTER  
Principal Investigator: 
Kalpana Poudel-Tandukar, Ph.D., MPH, MPHC, CGM 
Assistant Professor, College of Nursing, 220 Skinner Hall, 651 North 
Pleasant St., University Massachusetts Amherst, MA, 01003  
 
Email: kalpana@umass.edu 
 
Phone: 413 545 5095 
 
 
Co-Investigator:               Steven D Hollon, Ph.D. 
 Professor, Department of Psychology, 306 Wilson Hall, 111 21st 
Avenue South, Vanderbilt University, Nashville, Tennessee, 37240 
 
Email: steven.d.hollon@vanderbilt.edu 
 
Phone: 615 322 3369 
Co-Investigator:               Christopher Martell, Ph.D. 
 Director, Psychological Services Center, and Lecturer, Psychology 
and Brain Sciences, 137 Tobin Hall, 135 Hicks Way, College of 
Natural Science, University Massachusetts Amherst, MA, 01003 
 
Email: cmartell@umass.edu 
 
Phone: 413 545 5943 
Co-Investigator:               Cynthia S Jacelon, Ph.D. RN-BC CRRN FGSA FAAN 
Professor, College of Nursing, 020 Skinner Hall, 651 North Pleasant 
St., University Massachusetts Amherst, MA, 01003  
 
Email: jacelon@nursing.umass.edu 
 
Phone: 413 545 9576 
 
 
Co-Investigator:               Elizabeth B Bertone-Johnson, Sc.D. 
Professor, School of Public Health & Health Science, 410 Arnold 
House, 715 North Pleasant St., University Massachusetts Amherst, 
MA, 01003  
  Email: ebertone@schoolph.umass.edu 
 Phone: 413 577 1672 
 
 
Co-Investigator:               Jerrold S Meyer, Ph.D. 
Research Professor, College of Natural Science, 526 Tobin Hall, 135 
Hicks Way, University Massachusetts Amherst, MA, 01003  

 
2 
  
Email: jmeyer@psych.umass.edu 
 
Phone: 413 545 2168 
Co-Investigator:              Holly Laws, Ph.D. 
Lecturer, College of Natural Sciences, 616 Tobin Hall, 135 Hicks 
Way, University Massachusetts Amherst, MA, 01003  
 
Email: hlaws@umass.edu 
 
Phone: 413 545 2383 
Co-Investigator:               Pamela Burris, MSN, RN, AHN-BC, RYT 500 hr, Yoga Trainer 
 Experienced Registered Yoga Teacher with Yoga Alliance (E-RYT,)  
Email: pkayburris@comcast.net 
  
 
 

 
3 
STUDY TEAM MEMBER RESPONSIBILITIES 
A. KEY PERSONNEL 
Kalpana Poudel-Tandukar, Ph.D., MPH, MPHC, CGM, Principal Investigator (PI)  
Responsibilities: Dr. Poudel-Tandukar will assume responsibility for all aspects of the proposed 
project, including study design, intervention development, training manual and guideline 
development, training staff, intervention implementation, measurement tools development, data 
collection, data analysis and interpretation, and progress reports and manuscript preparation, and 
preparation of the subsequent R01 application. She will work with the entire research team 
throughout the project, meeting monthly with Co-Is; and once every week with field staff 
(supervisors, interventionists, and research assistants) via in-person or skype as needed. She will 
do onsite supervision of fieldwork at least twice every month or more as needed. She will lead 
efforts to inform communities, health practitioners, and scientific communities of this 
investigation's results and disseminate relevant materials and resources related to studying 
findings and translation of research to practice.  
 
Cynthia S. Jacelon, RN, BC, Ph.D., CRRN-A, FAAN, Co-Investigator  
Responsibilities: Dr. Jacelon will contribute her expertise in qualitative research methods and 
dignity, sense of control, and self-management of health. She will be involved in research design, 
data collection, interpretation, and dissemination of findings, including manuscript preparation. 
She will advise PI on doing qualitative data analysis. 
 
Elizabeth R. Bertone-Johnson, ScD, Co-Investigator  
Responsibilities: Dr. Bertone-Johnson will contribute her expertise in life course epidemiology 
and quantitative research methods and involve studying design and data analysis decision 
making, data interpretation, and manuscript preparation. She will advise PI on doing quantitative 
data analysis of longitudinal data and multivariable modeling. 
 
Jerrold S. Meyer, Ph.D., Co-Investigator 
Responsibilities: Dr. Meyer’s role will focus on quality control for hair samples assays for 
cortisol levels. He will also analyze and explain data on the relationship between the bio-

 
4 
physiological marker of stress, cortisol, and the results of the survey questionnaire scales that 
measure stress, the Cohen Perceived Stress scale. 
 
Pamela Burris, MSN, Faculty Collaborator  
Responsibilities: Ms. Burris will train ten community interventionists to deliver yoga 
intervention at the family level. She will provide training to the community interventionists to 
provide yoga and supervise their work in coordination with PI. She will also help PI to develop a 
yoga manual, CD, and pamphlets. 
 
Christopher Martell, Ph.D. (Consultant through Psychological Services Center) 
Responsibilities: Dr. Christopher Martell, consultant through Psychological Services Center 
(PSC), will be responsible for developing training manual, intervention guidelines and provide 
ten full days of extensive training on behavioral activation to the community interventionists in 
how to deliver Problem Management Plus for Immigrants intervention. He will provide two days 
of full training to the community supervisor on the supervision of intervention delivery. He will 
also supervise their work in coordination with PI during the intervention implementation phase 
in the field. He will advise PI to develop training materials, including homework practice sheets, 
information brochures, record-keeping charts, and other necessary documents. 
 
Holly Laws, Ph.D., Faculty Collaborator 
Responsibilities: Dr. Holly Laws, consultant through the Center for Research on Families 
Methodology Program at UMass Amherst, will be responsible for providing necessary statistical 
guidance to PI to conduct the data analysis of multivariable modeling dyadic longitudinal data 
analysis. 
 
Steven Hollon, Ph.D., Co-Investigator  
Responsibilities: Dr. Hollon brings expertise to research design and the development and testing 
of culturally adapted interventions for treatment and prevention. He will advise research design 
and assessment, intervention development and implementation, and assist in manuscript 
preparation. 
 

 
5 
B. OTHER PERSONNEL 
Undergraduate Research Assistant  
Responsibilities: The Undergraduate Research Assistant will be the main liaison between the PI 
and other academic and field staff. The Undergraduate Research Assistant will be responsible for 
the study's coordination and management, including organizing meetings and training, logistics 
arrangements for fieldwork, and preparing meeting minutes and field progress reports. The 
Undergraduate Research Assistant will prepare copies of the training manual, intervention 
guidelines, survey questionnaire, and other necessary forms, distribute them to field staff, and 
collect them back from field staff in coordination with the community supervisor. 
 
Community Supervisor (2) 
Responsibilities: The Community Supervisors will guide community interventionists and 
supervise their work during intervention delivery at family. They observe intervention delivery 
with a fidelity checklist, collect data from participants at the end of intervention using a 
feasibility checklist, logistic arrangement for community interventionist, prepare intervention 
delivery progress report, and submit them to Undergraduate Research Assistant. 
 
Community Interventionists (8)  
Responsibilities: Community Interventionists will be responsible for delivering five days 
intervention package using the training manual at the family level, keep a record of intervention 
delivery, prepare field progress reports, and report progress and any constraints to the 
community supervisor and PI. 
 
Community Research Assistants (6) 
Responsibilities: The Community Research Assistants will be responsible for recruiting study 
participants, take informed consent, conduct a quantitative survey, and measure height, weight, 
waist circumference, and blood pressure at baseline, post-intervention, and three months after 
intervention and keep a record of the completed survey. They will also take a hair sample from 
participants at baseline and three months after the intervention, store them properly in a dry 
white envelope, and submit completed questionnaires and hair samples to Undergraduate 
Research Assistant. 
 

 
6 
 
 
COMMUNICATION PLAN 
 
 
 
 
 
 
 

 
7 
1 
STUDY OBJECTIVES 
 
1.1 
Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will 
have significantly lower stress and anxiety/depressive symptoms than immigrants in the 
talk program with Community Support Service pamphlets (CSS).  
 
1.2 
Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I 
among Bhutanese immigrants 18 years and older living in Massachusetts.  
 
Aim 1: Adapt and culturally modify PMP to develop PMP-I as a family-based preventative 
intervention.  
a) Develop a training guide and intervention curriculum;  
b) Obtain iterative feedback about the format, ease of use, and implementation barriers 
from participants, facilitators, and community members. 
 
Aim 2: Test the feasibility, acceptability, and preliminary outcomes of PMP-I with trained 
community facilitators.  
a) Assess i) recruitment, session attendance, and retention rates and program acceptability 
using checklists from participants; ii) feasibility of measures for assessing 
inclusion/exclusion, the fidelity of intervention delivery, mediators of response, and 
outcomes using checklists from facilitators; and iii) barriers and facilitators of 
intervention using interview and focus group discussion with participants and facilitators.  
 
b) Test preliminary effects of PMP-I vs. talk program with community support services 
pamphlets (CSS) using a small randomized pilot trial (N=116 families; 58 families per 
intervention and control), on perceived stress, anxiety and depressive symptoms 
(primary), physiological stress assessed in hair cortisol (secondary), and self-efficacy and 
coping strategy, family wellbeing, and social networking (targets), with assessments at 
baseline, post-intervention, and 3-month post-intervention. 
 
c)   Evaluate the relationships between targets and outcomes and explore mediators (e.g., 
coping) of intervention-outcome relation. 
 
 

 
8 
2 
BACKGROUND AND RATIONALE  
2.1 Background  
Traumatic experiences and everyday stressors during and after migration contribute to the 
emergence of depression and other mental health problems among immigrants.3-15 
Immigrants living in the U.S. are more vulnerable to depression, anxiety, and psychological 
distress than the general population.3, 7, 9, 10, 16-19 Although mental health treatments help 
alleviate the social and economic costs of mental disorders, immigrants underutilize such 
services.20-22 For instance, Asian Americans use fewer mental health-related services 
compared with the general population; only 8.6% of Asian Americans sought any mental 
health-related services versus 17.9% of the general population in the National Comorbidity 
and Replication study.22 In the National Latino and Asian American Study, only 8.5% 
(179/2095) of the total national sample of Asian Americans and 36.1% (68/188) of 
individuals who had a probable diagnosis of a psychiatric disorder sought mental health-
related services.20 Research suggests that culturally tailored, community-oriented strategies 
are needed to overcome barriers and prevent mental illness.23 Specifically, the CDC 
recommends using a non-clinical, community support approach to prevent mental illness 
among refugees resettled in the U.S.24 
 
 
Stress resulting from attempts to integrate into a new culture while maintaining one’s 
own culture takes a heavy toll on newly settled immigrants' mental health.25 Immigrants’ 
risk for mental health problems increases during their acculturative process due to exposure 
to multiple stressors such as adjusting to a new culture with limited language26, 27 and 
socio-cultural skills, and a lack of culturally-mediated and protective social support 
resources.28-30 Language problems can impede social and professional integration, reduce 
self-esteem, create social isolation, and increase stress. Perceived stress of acculturation14, 
15, 31-33, or discrimination4, 34 is strongly associated with immigrants' psychological distress. 
Previous studies point to difficulties immigrants encounter in various spheres of daily life 
such as acculturation to employment,35-37 housing,35-37 and education;35, 37 changes to 
family roles and obligations;38 inadequate parenting skills,38 and weak bonds in family and 
social ties.38  
Bhutanese immigrants are one of the most disadvantaged newly settled populations 
residing in inner cities in the U.S. In Hampden County, MA—consistently ranked the 

 
9 
poorest county in the state—there are approximately 4,000 Bhutanese. Our need assessment 
studies39-41 found a high prevalence of depression (23.8%), anxiety (34.5%), and perceived 
high stress (38.1%) among Bhutanese immigrants living in Western MA. Unlike other South 
Asian immigrants, Bhutanese immigrants come from rural farming backgrounds and 
typically are illiterate. It is hard for them to learn English quickly and thus be able to 
communicate and work in the U.S. Limited literacy skills impede learning other social skills 
required to adapt to a new culture. We found that Bhutanese tend to rely exclusively upon 
their own ethnic, cultural, and religious supports and are less willing to explore and use 
resources and services from the host community. Their culture of interdependence impedes 
them from exploring their host culture and engaging in social and recreational activities 
outside of their own culture, leading to social isolation. One of the most prevalent 
community concerns is coping with the overall lack of support and isolation found in a new 
country. Lack of motivation and confidence to learn new skills and feelings of social 
isolation are the major stressors highlighted by the Bhutanese immigrants living in Western 
MA.40 Understanding these cultural dynamics are essential for designing culturally tailored 
mental health promotion program. 
 
2.2 Study Rationale 
Existing interventions are primarily based on treatment models to improve access to and 
quality of care for immigrants with diagnosed mental health problems;42, 43 however, 
culturally tailored, preventative behavioral interventions aimed at preventing or reducing 
mental health problems are limited. For prevention, a culturally tailored intervention that 
addresses multiple psycho-socio-cultural stressors holds the most promise.44-47 Problem 
Management Plus (PMP) is a low-intensity evidence-based psychological intervention 
developed by the World Health Organization that can be delivered by trained laypeople.48, 
49 PMP systematically teaches four strategies: stress management through breathing 
exercises, problem-solving, behavioral activation, and skills to strengthen social support at 
the individual level. The current study plans to adapt PMP to develop the PMP for 
Immigrants (PMP-I) for a family setting to address immigrant’s multiple social and 
emotional stressors while adjusting to the United States' new multi-cultural environment. 
The rationale to adapt PMP is based on our intervention model that demands an integration 

 
10 
of social and emotional stressors; promising results of PMP; strong evidence of family and 
community ties in health care process; and growing consensus among community, 
scientists, and policymakers on the need for family-based care models that are sustainable. 
PMP-I is a 5-week, peer-led, culturally tailored mental health promotion program that 
includes psychoeducation, behavioral activation, problem-solving (90 
mhnutes/session/weekly), breathing exercises, and yoga (90 minutes/session/weekly) in a 
family setting. 
 
3 
STUDY DESIGN 
Study design: This mixed-methods study will 
incorporate a two-arm randomized controlled 
feasibility trial and qualitative evaluation of the 
acceptability of Problem Management Plus for 
Immigrants (PMP-I) intervention to a range of 
stakeholders. 
Allocation: Randomized 
Intervention Model: Parallel Assignment  
Masking: None 
Primary purpose: Prevention 
 
Outcome Measures 
Name: Anxiety & Depressive Symptoms 
Type: Primary 
Time Frame: Baseline, Post-intervention, 3-
month Post-intervention 
Brief Description: The Hopkins Symptom 
Checklist-25 (HSCL-25) 2 will be used to measure anxiety and depressive symptoms  
experienced over the past month. It is composed of a 10-item subscale for anxiety and a 
15-item subscale for depression, with each item scored on a Likert scale from 1 (not at 
all) to 4 (extremely). The scale was validated for use in Nepal with a clinical DSM-IV 
diagnosis of major depressive disorder. The sensitivity and specificity with a cutoff point 

 
11 
of 1.75 were 0.87 and 0.60, respectively, with an area under the curve of 0.79.50 The 
HSCL-25 has widely been used in studies among refugees in other countries as well as 
Nepal. The HSCL-25 score was categorized into two groups: the cutoff score of 1.75; 
depressed (1.75 or more), and not depressed (below 1.75). The scale has high internal 
consistency for anxiety (Cronbach’s α = 0.92) and depression (Cronbach’s α = 0.94) in 
our previous study with the same population group.39 
 
Name: Perceived Stress 
Type: Primary 
Time Frame: Baseline, Post-intervention, 3-month Post-intervention 
Brief Description: The 10-item Cohen Perceived Stress Scale (PSS)1 will assess 
perceived stress. The PSS uses a 5-point Likert scale (ranging from 0, “never” to 4, “very 
often”) to assess psychological stress experienced during the past month, including the 
extent to which situations felt unpredictable, uncomfortable, and overwhelming. The 
items included in the PSS scale are easy to understand as it was designed for use with 
community samples with junior high school education. This scale has been widely used 
in diverse populations, including immigrants. The scale has high internal consistency 
(Cronbach’s α = 0.80) in our previous study with the same population group.39  Items 
were summed to provide a total score with higher scores indicating greater perceived 
stress.  
 
Name: Physiological stress 
Type: Secondary 
Time Frame: Baseline, 3-month Post-intervention 
Brief Description: We will use the ELISA cortisol hair-test (average hormone levels 
over the past three months) as a biomarker to measure physiological stress. 
Neuroendocrine indicators, such as cortisol, are effective stress biomarkers because they 
are the first to respond to a given stressor and coordinate the physiological response of 
other bio-physiological systems. Biomarker measurement helps to overcome the 
limitations of self-report because it provides an objective marker of levels of stress. Hair 
samples will be processed in the neuroendocrine lab at UMass.51, 52 Sensitive and specific 

 
12 
enzyme immunoassay (Salmetrics) will be used for the analysis. The assay has intra- and 
inter-assay coefficients of variation of <10%. The cortisol distribution will be tested for 
normality, and if the data are not normal, they will be log-transformed before statistical 
analysis.  
 
Study Location and Population:  
Bhutanese adults resettled in Massachusetts, USA. 
 
Study Arms: 
Experimental: Problem Management Plus for Immigrants (PMP-I) at family settings (58 
families) 
Active Comparator: Talk program with Community Support Service Pamphlet (CSS) (58 
families) 
 
Intervention: 
PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation 
(90 minutes), breathing, and yoga intervention (90 minutes) in a family setting. PMP-I 
will use a structured approach, including a once-a-week face-to-face session, breathing, 
and yoga practices.  
1. Managing Stress: Breathing and yoga practices, stress-management sessions, and 
behavioral activation exercises to strengthen positive coping strategies. 
2. Managing Problems: Practice exercises to identify the problems, develop solutions, 
and plan a strategy to carry out those solutions. 
3. Behavior Activation: Communication skill sessions and practice exercises to identify 
and carry out pleasant tasks. 
4. Strengthening Social Support: Social skills session and practice exercise to identify 
some support. 
5. Staying Well:  Make a plan that helps to create a supportive family environment. 
 

 
13 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
We plan to include eligible adults aged 18 or older interested in participating in the study as 
primary study participants. This includes parents and their adult children aged 18 and 
above. At baseline, we will use our screening tool to identify individuals without 
significant depressive symptoms, as we aim to evaluate the effect of our intervention to 
prevent depression, rather than treat depression.  
Eligibility criteria for our primary study participants include Bhutanese adults 18 years 
or older (both parents and children of each family) resettled in Massachusetts with a score 
14 or below on the Patient Health Questionnaire (PHQ-9), a screening questionnaire for 
depression. Our statistical analysis will focus on data from primary study participants only 
with baseline PHQ-9 scores 14 or below. However, all other interested adult family 
members, both parents and their adult children, regardless of PHQ-9 score, will be invited 
to participate in our study, to maintain the confidentiality of each family member’s mental 
health status within their family.  
Besides, individuals with PHQ-9 screening score ‘15-19’ (moderately severe 
depression) and ‘20-27’ (severe depression) will be provided with feedback on their 
screening questionnaire outcomes confidentially. They will be encouraged to consult their 
primary health care providers. A field supervisor can provide the necessary support for 
setting up an appointment with primary health care providers and emergency services, as 
needed. A field supervisor also will make a follow-up home visit to monitor their mental 
health condition, as necessary.  
 
4.2 Exclusion Criteria  
Participants with clinically diagnosed mental disorders and those taking psychiatric 
medications for any mental health problems will also be encouraged to participate in the 
family-based intervention activities. However, we will not consider data from those 
participants with PHQ-9 scores 15 or above or diagnosed with mental health problems in 
our main statistical analysis. 
 

 
14 
4.3 Study Enrollment Procedures  
Identifying survey participants  
The PI has already established a strong network with the Bhutanese community and 
completed her needs assessment studies collecting determinants of a mental health problem 
through engaging community members in the research process. We will use an existing 
community network to spread the study information in coordination with church leaders, 
community research assistants (RAs), and supervisors. PI will prepare an oral script 
including study objectives, eligibility criteria, intervention procedure, study and survey 
information, hair sample collection, and informed consent procedure. It will also distribute 
it to them to spread the study information. They will be requested to disseminate the 
information about the study purpose and process to their community in phone or in-person 
meetings in any of their gatherings, word of mouth, formal/informal discussions, and 
festivals to check-in for their interest to participate in the study. Interested participants will 
be requested to contact PI, RAs, and supervisors.  
 
Recruiting survey participants 
Community RAs from the local area will be mobilized to reach interested families to check 
their eligibility and make a list of eligible participants. Eligibility criteria for participants 
are: being Bhutanese adults 18 years or older resettled in Massachusetts with a score of 14 
or below on the Patient Health Questionnaire-9, showing commitment to complete the 
intervention procedure, and giving informed consent to participate in the study. RAs will 
recruit interested eligible participants with their informed consent and will conduct a 
baseline survey. RAs will be asked to leave a note in the screening tool and screening log 
of reasons for ineligibility, such as a PHQ-9 score of more than 14 or any history of 
clinically diagnosed mental health problems or taking any medication related to mental 
health problems. RAs will also leave a note for non-participation of eligible candidates in 
the screening tool and screening log. 
 
Randomizing study participants for intervention and control 
We will randomly allocate selected families into intervention and control groups using a 
random sampling method after the baseline survey. We will randomly assign 116 interested 

 
15 
families (58 families per intervention and control) using a random number table. For 
random allocation, first, PI will prepare the sampling frame that lists interested families. 
Second, assign a number to each family in the sampling frame. Third, select 116 numbers 
using a table of random numbers. PI will request any interested community member to 
point one number in the random number table by closing his/her eyes. Since the selected 
families total 116, or three digits, we will choose only the first three digits of the number 
chosen as the first sampled family. Finally, we will choose other numbers moving down the 
first number column until all 116 families will be selected.  
 
We will assign a random number selected at the first attempt for intervention and the 
second attempt for control. It means random numbers selected at odd attempts (first, third, 
seventh, …..) will be assigned for intervention and at even attempts (second, forth, sixth…) 
for control. The sample elements corresponding to the selected random numbers become 
the sample. Procedures are in place for tracking the participants for intervention and 
follow-up (e.g., contact address and phone). RAs will visit selected families and brief them 
about study procedures, informed consent, and procedures to protect human subjects. All 
adult members of selected families who meet the inclusion criteria and give informed 
consent will be recruited for the study. We will follow up with all families randomized to 
either study arm. We will not follow up with participants if they decide to end their 
participation at a particular time point of our study. But, we will include their already 
collected data in our analysis. Given our strong community networks and mobilization of 
community RAs, we anticipate low attrition rates in practice. Ethical approval for our study 
will be obtained from the Institutional Review Board at UMass Amherst.  
 
Recruitment of focus group discussion participants  
PI will collect data on engagement, acceptability, and satisfaction of intervention delivery 
by conducting focus group discussions (FGD) with selected interested participants who are 
already enrolled in our study from the intervention group (30) upon intervention 
completion using a brief guide questionnaire. The participant will be eligible to attend the 
focus group discussion if they are already enrolled in our intervention group and have 
attended our mental health promotion program. RAs will inform participants about FGD 

 
16 
details verbally while implementing our mental health promotion program. We will recruit 
interested participants on a first-come-first-serve basis until we get enough participants.  
 
Informed consent procedure 
PI will prepare an informed consent document including an explanation on study 
background, rationale, screening criteria, inclusion and exclusion criteria, study setting, 
sample size, data collection and intervention procedures, study risks and benefits, privacy 
and confidentiality of personal information, National Institute of Mental Health Data 
Archive (NDA) data sharing policy, hair samples collection procedure, storage, and testing 
procedure, participant compensation, study policy, and study contact person details. PI will 
train community RAs and field supervisors about processes of taking informed consent 
from participants.  
RAs will inform screening and study procedures to each participant using UMass 
Amherst IRB approved single informed consent form. A copy of the informed consent 
form will be provided to each participant for their review. If they want, RAs can read 
informed consent for them. Participants will be given enough time to review informed 
consent and ask questions if they have any confusion. RAs will make sure that participants 
understand about study procedure, privacy and confidentiality of private information, and 
data sharing policy of NDA. They will be reminded that their participation in the study is 
voluntary and free to leave the study without penalty. Once participants understand about 
study details, RAs will request them to do their signature or write their initials or 
fingerprint for those who cannot write their names in the two copies of the informed 
consent form before collecting their information. One copy of signed informed consent will 
be provided to each participant. We will not recruit any individuals who are unable to 
consent for themselves. The signed informed consent documents will be stored securely in 
the locked cabinet of the PI’s office. (Please see the attached informed consent for details) 
 
 

 
17 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
Intervention group: Each participant's involvement will be 5-sessions of the PMP-I 
program of 180 minutes each for a total of 900 minutes. We will request intervention group 
participants to complete five sessions of PMP-I intervention. Each session is about 180 
minutes. Our proposed family-based mental health intervention is a 5-week, culturally 
tailored stress management, behavioral activation, problem-solving (90 minutes), and 
mind-body exercises, including yoga and breathing exercises (90 minutes) at a family level 
delivered by trained community interventionists at their family settings.  
Control group: We also plan to implement five talk programs about community support 
services to control group participants. Each participant's involvement will be 5-sessions of 
a talk program of 60 minutes each for a total of 300 minutes.  
Post-Intervention for Control group: Each participant's involvement will be 2-sessions 
of mental health intervention of 120 minutes each for a total of 240 minutes.  
Training for Community Interventionists: We will train community members to deliver 
the intervention in family settings. Dr. Christopher Martell will provide 12 full-day training 
to the community interventionists in collaboration with PI and Dr. Steven D Hollon 
following the World Health Organization PM+ training manual. We will provide a PMP-I 
program manual describing the procedure of delivering each intervention component to 
community interventionists. They will use the intervention manual to provide PMP-I to 
community members at family settings under field supervisors and PI's supervision. (Please 
see attached the PMP-I intervention manual for the details) 
Local community members with a high school level of education and no formal training 
or prior experience with mental health service providers will deliver the PMP-I. First, Drs. 
Hollon and Martell will review with the PI the PMP-I Manual, fidelity checklists, and other 
training materials. Second, Dr. Martell will provide ten full days (80 hours) of intensive 
classroom training to community interventionists (CI) using the PMP Helpers’ Training 
Guide. Classroom training includes information about stress and depression, the rationale 
for each of the strategies, necessary helping skills, extensive role-plays, peer observations, 
and group discussion related to core intervention concepts. Third, Dr. Martell will provide 
an additional two days of training in supervision to the same CIs so that they can play the 

 
18 
dual role of interventionists and supervisors as needed. Supervision involves discussing 
participants’ progress and difficulties experienced when delivering strategies and role-
playing on managing problems or practicing skills. Fourth, following classroom training, 
the PI will provide field training with at least two participants for five sessions. Finally, 
after overall training, we will conduct a formal evaluation of the interventionists' readiness 
to implement/supervise the PMP-I intervention such as using the manual, answering 
questions, and managing time, using a fidelity checklist, practice exercise, and role play, 
and will provide feedback as necessary.  
Ms. Burris will provide 4 hours of breathing exercises and 16 hours of yoga practice to 
CIs and field supervisors using a Yoga Training Guide. Classroom training includes 
theoretical and practice exercises to guide participants in mind-body exercises for attention 
to breath, body sensation, emotional awareness, and mental function on different postures 
of yoga practices such as Pranayama (3 poses) and Asana (21 poses). Training will include 
practice assessment at the end to ensure that all staff was adequately trained, using a 
checklist, practice exercise, and role-plays. (Please find attached the mind-body exercise 
manual for the details) 
 
Intervention Components  
Psychoeducation: A brief educational session on stress management to increase awareness 
of the health benefits of reducing stress. To address the social isolation of many 
immigrants’ in a new culture, we plan to educate on multi-cultural communication and 
social networking to promote their cross-cultural interaction.  
Behavioral activation (BA): In BA, we plan to propose behavior modification activities 
with a specific focus on identifying and strengthening positive coping styles for immigrants 
adapting to a new cultural environment as members of the immigrant community feel relief 
talking in person and prefer doing culturally appropriate behavior modification activities to 
other more traditional western psychotherapies.  
Problem-solving (PS): In PS, we plan to include practice exercises in identifying and 
trying at least three best problem-solving measures that would help manage stress, and 
strengthening coping, communication, and social networking skills.  

 
19 
Mind-Body Exercise (MBE): Yoga and breathing exercises are a mind-body intervention 
scientifically sound and well known in the community. They are included in our 
intervention as community members viewed yoga and breathing exercises as a culturally 
preferred essential part of stress management and are critical contributors to the stress 
reduction observed in our pilot programs.  
Strengthening social support (SS): In SS, we plan to include practice exercises to identify 
and try at least three best social events that would help make them feel better and happy. 
 
5.2 Adherence Assessment  
The PMP trainers training guidelines developed by the World Health Organization provide 
specific tools for evaluating and monitoring the intervention that we will use to monitor 
fidelity of intervention delivery. These tools are PMP Quiz, PMP Helper’s Supervision 
Form, PMP Helper Classroom-based Competency Assessment, PMP Helper In-field based 
Competency Assessment, PMP Trainer/Supervisor Competency Assessment, and Session-
by-Session Checklists for PMP Helpers. We have adapted these tools in the context of our 
program contents. (Please find attached PMP-I program monitoring tools for the details) 
Using these standard tools, we will evaluate session-by-session classroom and in-field 
based competencies of participants, community trainers, and supervisor and provide them 
feedback as needed using supervision forms, role-plays, group discussion, and training. 
After each session and program completion, the field supervisor will collect data on 
engagement, acceptability, and satisfaction via a brief questionnaire and qualitative 
interviews with community interventionists. The field supervisor will also collect data on 
adherence to the manual, percent of intervention content administered, proper use of time 
and materials, and adequate response to participants’ questions through field observation of 
community interventionists’ work.  
Field supervisors will collect data on eligibility, recruitment and enrollment, 
intervention session attendance (including reasons for missed sessions), and compliance 
with data collection procedures, including hair sample collection and anthropometric 
measurements using a checklist. They will monitor intervention sessions using WHO 
standard checklists. Items include adherence to the manual, percent of intervention content 
administered, proper use of time/materials, and adequate response to participants' 
questions. They will also collect data on engagement, acceptability, and satisfaction via 

 
20 
brief questionnaires and focus group discussions (FGD) with participants and 
interventionists after each session and upon intervention completion.  
The PI will conduct FGD in the Nepali language with interventionists, supervisors, and 
participants separately to collect information on barriers and facilitators of intervention, 
perceptions about whether the intervention met participants' needs, and feedback on how 
effectively the program team worked with participants. Interviews and FGD will be 
documented verbatim in a written transcript for subsequent analysis. All qualitative data 
will be analyzed using thematic content analysis.53 Feedback provided by the field staff 
will be reviewed and coded to identify recurrent themes regarding the intervention's 
acceptability. All analyses will be conducted in Nepali and translated into English. Fidelity 
data will be used to assess intervention content and transmission. We will determine 
retention by obtaining proportions of participants attending all or portion of sessions. 
 
6 
STUDY PROCEDURES 
 

 
21 
6.1 
Schedule of Evaluations   Participant Name: _________________   Mention DATES mm/dd/yy in below table for each activity. 
 
Assessment 
Screening: 
Visit 1 
(Day 0) 
Baseline, 
Enrollment,  
Randomization: 
Visit 1 (Day 0) 
Treatment Visit 
2  
Day 7 (± 2 
Days) 
Treatment Visit 
3 
 Day 14 (± 2 
Days) 
Treatment Visit 
4  
Day 21 (± 2 
Days) 
Treatment Visit 
5  
Day 28 (± 2 
Days) 
Treatment Visit 
6  
Day 35 (± 2 
Days) 
Follow up  
7 
Day 42 (± 2 
Days) 
Follow-up: 
Final Visit 
Day 132 (± 2 
Days) 
Informed Consent Form   
X 
  
  
  
  
  
  
 
  
Screening tool 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria  
X  
 
 
 
 
 
 
 
 
Demographics 
 
X 
  
  
  
  
  
X 
X 
Blood pressure 
 
X 
  
  
  
  
  
X 
X 
Bodyweight & height  
 
X 
  
  
  
  
  
X 
X 
Waist circumference 
 
X 
 
 
 
 
 
X 
X 
Hair samples 
 
X 
 
 
 
 
 
 
X 
Stress 
 
X 
 
 
 
 
 
X 
X 
Anxiety & Depression 
 
X 
 
 
 
 
 
X 
X 
Coping Strategies 
 
X 
 
 
 
 
 
X 
X 
Self-efficacy 
 
X 
 
 
 
 
 
X 
X 
Family Conflict Resolution 
 
X 
 
 
 
 
 
X 
X 
Family Satisfaction 
 
X 
 
 
 
 
 
 
 
Enrollment/Randomization 
  
X 
  
  
  
  
  
 
  
Intervention Session and its 
assessment using fidelity form  
  
  
X 
X 
X 
X 
X 
X  
X  
Adverse Events  
  
X 
X 
X 
X 
X 
X 
X 
X 

 
22 
6.2 Description of Evaluations  
6.2.1 Screening Evaluation 
These evaluations occur to determine if the participant is eligible for the study. 
Consenting Procedure 
Trained RAs will meet interested participants and inform them about screening and 
study procedures to each participant using UMass Amherst IRB-approved single 
informed consent form. A copy of the informed consent form will be provided to each 
participant for their review. If they want, RAs can read informed consent for them. 
Participants will be given enough time to review informed consent and ask questions 
if they have any confusion. RAs will ensure that participants understand screening, 
study procedure, privacy and confidentiality of private information, and NDA data 
sharing policy. They will be reminded that their participation in the study is voluntary 
and free to leave the study without penalty. Once participants understand about study 
details, RAs will request them to do their signature or write their initials or fingerprint 
for those who cannot write their names in the two copies of the informed consent 
form before collecting their information. One copy of the signed informed consent 
form will be provided to each participant. We will not recruit any individuals who are 
unable to consent for themselves. The signed informed consent form will be stored 
securely in the locked cabinet of the PI’s office. (Please find attached informed 
consent for details) 
 
Screening   
RAs will screen interested participants after obtaining their informed consent on the 
same day. We plan to include eligible Bhutanese adults aged 18 or older interested in 
participating in the study as primary study participants. This includes parents and 
their adult children aged 18 and above. At baseline, we will use our screening tool to 
identify individuals without significant depressive symptoms, as we aim to evaluate 
the effect of our intervention to prevent depression rather than treat depression. 
Eligibility criteria for our primary study participants include Bhutanese adults 18 
years or older (both parents and children of each family) resettled in Massachusetts 
with a score of 14 or below on the Patient Health Questionnaire (PHQ-9), a screening 

 
23 
questionnaire for depression. Our statistical analysis will focus on data from primary 
study participants only with baseline PHQ-9 scores 14 or below. However, all other 
interested adult family members, both parents and their adult children, regardless of 
PHQ-9 score, will be invited to participate in our study, to maintain the 
confidentiality of each family member’s mental health status within their family.  
Besides, individuals with PHQ-9 screening scores ‘15-19’ (moderately severe 
depression) and ‘20-27’ (severe depression) will be provided with feedback on their 
screening questionnaire outcomes confidentially and encouraged to consult their 
primary health care providers. A field supervisor can provide the necessary support 
for setting up an appointment with primary health care providers and emergency 
services, as needed. A field supervisor also will make a follow-up home visit to 
monitor their mental health condition, as necessary. Participants with clinically 
diagnosed mental disorders and those taking psychiatric medications for any mental 
health problems will also be encouraged to participate in the family-based 
intervention activities. However, we will not consider data from those participants 
with PHQ-9 scores of 15 or above or diagnosed with mental health problems in our 
primary statistical analysis. RAs will keep a record of participants using the attached 
screening log. 
 

 
24 
 
SCREEN LOG 
Study: ______________________________________________________ 
Site:  _______________________________________________________ 
Investigator:  ________________________________________________ 
Screening 
Number 
Participant 
Names 
Date of 
Birth 
Gender 
 
Screening 
Date 
Screening 
Status 
(use codes 
below) 
Consent 
Obtained 
Enrolled 
(if no, indicate 
reason from 
codes below) 
Date 
Enrolled 
 
 
/      / 
mm/dd/yyyy 
 M 
 F 
/      / 
mm/dd/yyyy 
 
 Yes 
 No 
 Yes 
 No 
/      / 
mm/dd/yyyy 
 
 
/      / 
mm/dd/yyyy 
 M 
 F 
/      / 
mm/dd/yyyy 
 
 Yes 
 No 
 Yes 
 No 
/      / 
mm/dd/yyyy 
 
 
/      / 
mm/dd/yyyy 
 M 
 F 
/      / 
mm/dd/yyyy 
 
 Yes 
 No 
 Yes 
 No 
/      / 
mm/dd/yyyy 
 
 
/      / 
mm/dd/yyyy 
 M 
 F 
/      / 
mm/dd/yyyy 
 
 Yes 
 No 
 Yes 
 No 
/      / 
mm/dd/yyyy 
 
 
/      / 
mm/dd/yyyy 
 M 
 F 
/      / 
mm/dd/yyyy 
 
 Yes 
 No 
 Yes 
 No 
/      / 
mm/dd/yyyy 
Sample Screen Status Codes: 
1-Eligible  
2-Eligible, declined participation 
3-Not Eligible 
4-Eligible, lost to follow up 
5-Other, specify in space provided  

 
25 
 
6.2.2 Enrollment, Baseline, and Randomization 
Enrollment 
In this study, the enrollment date is the day the participant has met all the screening 
criteria and signs a single informed consent form that describes both screening and 
study procedures. RAs will record the enrollment date on a case report form along 
with the allowable window between screening and randomization.  
 
Baseline Assessments 
For participants who will have successfully been screened for eligibility and are 
enrolled in the study, baseline assessments will be performed to measure the study 
outcome on the same day of enrollment. We will measure study outcomes as listed 
below: 
 
Anxiety and Depressive Symptoms 
The Hopkins Symptom Checklist-25 (HSCL-25) 2 will be used to measure anxiety 
and depressive symptoms2 experienced over the past month. It is composed of a 10-
item subscale for anxiety and a 15-item subscale for depression, with each item 
scored on a Likert scale from 1 (not at all) to 4 (extremely). The scale was validated 
for use in Nepal with a clinical DSM-IV diagnosis of major depressive disorder. The 
sensitivity and specificity with a cutoff point of 1.75 were 0.87 and 0.60, respectively, 
with an area under the curve of 0.79.50 The HSCL-25 has widely been used in studies 
among refugees in other countries as well as Nepal. The HSCL-25 score was 
categorized into two groups: the cutoff score of 1.75, depressed (1.75 or more), and 
not depressed (below 1.75). The scale has high internal consistency for anxiety 
(Cronbach’s α = 0.92) and depression (Cronbach’s α = 0.94) in our previous 
Bhutanese study.39 
 
Perceived Stress 
The 10-item Cohen Perceived Stress Scale (PSS)1 will be used to assess perceived 
stress. The PSS uses a 5-point Likert scale (ranging from 0, “never” to 4, “very 
often”) to assess psychological stress experienced during the past month, including 

 
26 
 
the extent to which situations felt unpredictable, uncomfortable, and overwhelming. 
The items included in the PSS scale are easy to understand as it was designed for use 
with community samples with junior high school education. This scale has been 
widely used in different populations, including immigrants. The scale has high 
internal consistency (Cronbach’s α = 0.80) in our previous Bhutanese study.39  Items 
were summed to provide a total score with higher scores indicating greater perceived 
stress.  
 
Physiological stress 
We will use the ELISA cortisol hair-test (average hormone levels over the past three 
months) as a biomarker to measure physiological stress. Neuroendocrine indicators, 
such as cortisol, are effective stress biomarkers because they are the first to respond 
to a given stressor and coordinate the physiological response of other bio-
physiological systems. Biomarker measurement helps overcome the limitations of 
self-report because it provides an objective marker of stress levels. Hair samples will 
be processed in the neuroendocrine lab at UMass.51, 52 Sensitive and specific enzyme 
immunoassay (Salmetrics) will be used for the analysis. The assay has intra- and 
inter-assay coefficients of variation of <10%. The cortisol distribution will be tested 
for normality, and if the data are not normal, they will be log-transformed before 
statistical analysis.  
 
Coping strategy 
Coping strategy54 will be measured using a 32-item Coping Strategies Inventory-
Short Form (CSI-SF). The CSI-SF includes two overall coping factors, Engagement 
and Disengagement, and four secondary factors, Problem Engagement, Problem 
Disengagement, Emotion Engagement, and Emotion Disengagement. The CSI-SF 
scale (Cronbach’s α = 0.95) and its subscales problem engagement (Cronbach’s α = 
0.87), emotion engagement (Cronbach’s α = 0.89), problem disengagement 
(Cronbach’s α = 0.81), and emotion disengagement (Cronbach’s α = 0.78) have high 
internal consistencies in our previous Bhutanese study.39 A sample item for this scale 
is, “I worked on solving the problems in the situation.” Participants were asked to rate 

 
27 
 
their responses on a 5-point Likert-type scale ranging from not at all (1) to very much 
(5). Items are summed to provide sub-scale and larger composite scores with higher 
scores associated with greater adherence to that coping style.  
 
Self-efficacy 
Self-efficacy will be measured using a 26-item Coping Self-efficacy(CSE)55 scale for 
coping with challenges and threats. A sample item for this scale is “Do something 
positive for yourself when you are feeling discouraged.” Each item of the scale will 
be rated on an 11-point scale Likert-type scale ranging from (0) cannot do at all, (5) 
moderately certain can do, and (10) certain can do. Graded items will be summed up 
to provide a total score, and higher scores indicate high self-efficacy. The scale has 
high internal consistency (Cronbach’s α = 0.96) in our previous Bhutanese study.39  
 
Social support 
Perceived social support will be measured using a 12-item Multidimensional Scale of 
Perceived Social Support (MSPSS)56, 57 including support from friends, family, and 
significant others, and has been used cross-culturally. A sample item for this scale is, 
“My family tries to help me.” Each item of the scale will be rated on a 5-point Likert-
type scale ranging from strongly disagree (1) to strongly agree (5). Graded items will 
be summed up to provide a total score, and higher scores indicate high social support. 
The scale has high internal consistency (Cronbach’s α = 0.92) in our previous 
Bhutanese study.39 
 
Social network 
A social network including size, closeness, and frequency of active and intimate 
networks of family or friends will be measured using a 12-item version of the 
“Lubben Social Network” scale.58 It consists of six questions, which assess kinship 
ties, and a comparable set of six questions, which determine friend ties by replacing 
the word relatives with the word friends. A sample item from this scale is, “How 
often is one of your relatives available for you to talk when you have an important 
decision to make?” Participants will be asked to respond on a 6-point Likert-type 

 
28 
 
scale, ranging from less social engagement (0) to more social engagement (5). Scores 
across all items will be summed up to provide a total score, and higher scores indicate 
a high social network. We prepared three questions to measure cross-cultural social 
ties following a similar pattern. The scale has high internal consistency for kinship 
ties (Cronbach’s α = 0.78), friendship ties (Cronbach’s α = 0.80), and cross-cultural 
social ties (Cronbach’s α = 0.74) in our previous Bhutanese study.39   
 
Family conflict resolution 
Family conflict resolution, including positive or negative resolution, effective 
communication, and discussion of differences will be measured using a 17-item 
version of the “Family Conflict Resolution” scale.59 A sample item from this scale is, 
“In my family, when we have an argument we usually work it out.” Participants will 
be asked to respond on a 7-point Likert-type scale, ranging from never (1) to always 
(7). Scores across all items will be summed up to provide a total score, and higher 
scores indicate high family well-being. The scale has high internal consistency 
(Cronbach’s α = 0.92) in our previous Bhutanese study.39 
 
Family satisfaction: Family satisfaction with various aspects of family functioning, 
including family closeness, flexibility, and communication will be measured using a 
10-item family satisfaction scale.60 A sample item from this scale is, “How satisfied 
are you with the degree of closeness between your family members.” Participants will 
be asked to respond on a 5-point Likert-type scale, ranging from very dissatisfied (1) 
to extremely satisfied (5). 
 
Randomization 
Participants will be randomly assigned to intervention and control groups within 7-
days of baseline survey completion. The first session of intervention will be delivered 
to the intervention and control groups within the seven days of baseline survey 
completion. 
 

 
29 
 
6.2.3 Follow-up Visits 
 Visit 2 Day 7 (± 2 Days): 
o Intervention Session 1  
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
 Visit 3 Day 14 (± 2 Days): 
o Intervention Session 2  
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
 Visit 4 Day 21 (± 2 Days): 
o Intervention Session 3  
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
 Visit 5 Day 28 (± 2 Days): 
o Intervention Session 4  
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
 Visit 6 Day 35 (± 2 Days): 
o Intervention Session 5  
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
 Visit 7 Day 42 (± 2 Days): 
o Post-Intervention Assessment of Study Outcomes 
o Intervention Fidelity Assessment Form 
o Adverse Events 
 
6.2.4 Completion/Final Evaluation 
 Final Visit Day 132 (± 2 Days): 
o 3-month Post-Intervention Assessment of Study Outcomes 
o Intervention Fidelity Assessment Form 
o Adverse Events 
 

 
30 
 
7 
SAFETY ASSESSMENTS  
7.1 Adverse Events and Serious Adverse Events  
The possible adverse events such as 1) reporting suicidal ideation; 2) discomfort with the 
PMP-I program content and/or evaluation procedures, and 3) risk of a breach of 
confidentiality of the collected data and/or by program personnel, and severe adverse 
events such as 1) suicide attempts and other events that involve hospitalization, disability, 
and/or death, will be reported in writing to the NIMH Program Officer according to pre-
determined expectations and timeframes with the NIMH policy 
(https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy.shtml). 
The PI will be responsible for the overall trial oversight in the community and safety of 
participants in the trial and will review all possible study-related and not-related adverse 
events. Field supervisors will also be responsible for describing and adhering to the 
procedures for identifying, monitoring, and reporting reportable events.  
 
Adverse events: All study participants will be monitored closely daily by the field 
supervisors under the PI's supervision throughout the study period. Field supervisors will 
request study participants and their family members to immediately report any 
unanticipated adverse events in their family, such as 1) reporting suicidal ideation; 2) 
discomfort with the PMP-I program content and/or evaluation procedures, and 3) risk of a 
breach of confidentiality, of the collected data and/or by program personnel to field 
supervisor or PI directly. Field supervisors will immediately report details of such adverse 
events to PI. The PI will be responsible for summarizing all adverse events that are deemed 
expected and/or unrelated to the study in the annual progress report submitted to the UMass 
Amherst IRB, ISM, and NIMH Program Officer by secure email. 
 
Serious adverse events: All study participants will be monitored closely daily by the field 
supervisors under the PI's supervision throughout the study period. Field supervisors will 
request study participants and their family members to report any unanticipated serious 
adverse event in their family, such as suicide attempts and other events that involve 
hospitalization, disability, and/or death, to the field supervisors or PI. Field supervisors will 
immediately report details of such adverse events to the PI. The PI will be responsible for 

 
31 
 
reporting them to the UMass Amherst IRB, ISM, and NIMH Program Officer by secure 
email within ten business days of the study team becoming aware of any serious adverse 
events. 
 
Unanticipated problems: Field supervisors will collect completed survey questionnaires 
and signed informed consent from the research assistant on the same day of data collection. 
The PI will collect them from the field supervisor every week. In the unlikely event that the 
field staff loses completed survey items, the PI will be responsible for reporting this to the 
UMass Amherst IRB, ISM, and NIMH Program Officer by secure email within ten 
business days of the investigator learning of the event. 
 
Protocol violations: The PI will strictly monitor field staffs’ protocol compliance while 
implementing different activities, such as participant enrollment and randomization, 
intervention compliance, and data collection through onsite supervisions and phone 
conversations with field staff and participants. The PI will be responsible for summarizing 
protocol violations (if any) in the annual progress report that will be submitted to the 
UMass Amherst IRB, ISM, and NIMH Program Officer by secure email. 
 
IRB/ISM suspensions or terminations: The PI will be responsible for reporting any 
suspension of IRB approval and termination of ISM to the NIMH Program Officer by 
secure email within three business days of receipt, including a reason(s) for the action.  
 
All reports to the NIMH Program Officer will be made in writing by secure email and will 
include the following information:  
• Identifying information for the research protocol (e.g., project title, investigator’s na
me, or grant/contract number); 
• The date on which the event occurred and the date of which the PI became aware of 
the event; 
• A detailed description of the event and impact on the participant(s); 
• A detailed description of the measures taken (including clinical) in response to 
the event (if any); 

 
32 
 
• Confirmation that the appropriate monitoring entities and regulatory bodies have 
been notified as needed; and 
• A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the event. 
 
7.2 Independent Safety Monitor (ISM) 
An Independent Safety Monitor (ISM) will be an independent member of mental health 
experts whose primary responsibility is to provide independent monitoring of this clinical 
trial in a timely fashion. We will select a member independent of any professional or 
financial conflict of interest (COI) with the research project and/or study investigators. A 
potential ISM member will provide the NIMH with his/her qualifications and a COI 
statement indicating that this individual has no direct involvement with the study or COI 
with the investigators conducting the study. The ISM will be guided by the NIMH policy 
governing independent data and safety monitoring boards 
(https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-
monitors-and-independent-data-and-safety-monitoring-boards.shtml). 
 
The primary responsibilities of the ISM will be: 
• Reviewing protocols, consent procedures, consent forms, and safety plans before 
study initiation; 
• Monitoring study progress, including recruitment and retention of participants, 
adverse events, serious adverse events, reasons for participant withdrawal, 
adherence to the timeline of the study, quality of data, and protocol violations or 
deviations; 
• Making recommendations about the continuation, modification, or termination of 
the trial, based on the balance of adverse events and beneficial outcomes; 
• Reviewing and approving amendments to trial protocols, including consent forms. 
 
Overall, the ISM will review enrollment data, safety data, and data integrity to maintain 
safety in the trial. The principal investigator (PI) will submit data reports once a year to the 
ISM. The data report submitted to the ISM will follow the established reporting format 

 
33 
 
developed in consultation with NIMH. The report will include the key variables necessary 
for monitoring the safety and quality of data collection and the integrity of the study, 
including inclusion criteria, informed consent, subject enrollment and retention, data 
confidentiality, intervention compliance, dropouts, adverse events, protocol compliance, 
data quality, and baseline characteristics of study participants. The ISM will have access to 
all safety and data quality information collected and have the authority to stop the study if 
it is determined that there are unacceptable risks to participants. The ISM will also review 
the study protocol, informed consent, and all relevant documents before the study's onset 
and review and approve amendments to these documents. The ISM will issue a monitoring 
report to the PI following each review. The PI will submit all review reports to the UMass 
Amherst IRB and NIMH Program Officer in annual progress reports. 
The PI will be responsible for monitoring procedures during the study, including 
enrollment, data and sample collection, and participant safety and well-being. During the 
trial, experienced field supervisors from the Bhutanese community, who are trained as a 
community health worker and have worked with the PI in previous church and family-
based mental health intervention studies with depressive and suicidal ideation outcomes, 
will take responsibility for the day-to-day oversight of the participants and field teams in 
the implementation of the trial. Field supervisors will immediately report any noted adverse 
events among participants, such as suicidal ideation, to the PI. The PI will report adverse 
events data to the ISM, UMass Amherst IRB, and NIMH Program Officer following NIMH 
guidelines for reportable events, as described below 
(https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy.shtml).  
To monitor trial protocol compliance and participants’ safety, the PI will visit the trial 
site once every two weeks or more if needed. The PI will also conduct a weekly meeting 
with field staff (in-person and online on a rolling basis) to perform the continuous review 
of data and participant safety. The PI will be available for discussions by telephone and via 
email for participants and field staff if needed at any time. The PI will review the adverse 
effects and responses of the trial at these meetings. With this trial monitoring plan, the PI 
will oversee the participant safety protocols and the timely follow-up of any adverse events 
or serious adverse events throughout the study, as well as the reporting of adverse events to 
the ISM. The overall purpose of the day-to-day supervision and field visits, and any 

 
34 
 
independent monitoring visits, will be to verify that: the well-being of trial participants is 
protected; reported trial data are accurate and complete, and the conduct of the trial 
complies with the approved protocol and amendments. 
 
7.3 Potential Risks and Mitigation Strategies 
We do not anticipate any significant risks due to participation in research-related activities, 
based on our previous pilot intervention experience with similar mental health outcomes in 
the same population.  
First, RA will remind each participant that if they perceive any question to be too 
personal, they can choose not to respond. Participants may feel hesitant to answer some of 
the questions regarding depression and suicidal ideation. In such cases, participants are free 
to skip such questions or are free to withdraw from participating in the study overall. If 
participants feel upset during or after completing the survey or find that some questions or 
aspects of the study triggered distress, the RA will immediately contact the PI. The PI will 
then immediately assist participants (in their native Nepali language) and help them to 
connect with mental health support services in coordination with the field supervisor. The 
RA will also provide them with contact information for emergency and other mental health 
support available locally but independent of the study. 
Second, the field-team will be trained to recognize potential risks that require immediate 
reporting, such as suicidal ideation. If any participants respond “yes” to a questionnaire 
item that measures suicidal ideation or develops suicidal ideation during the intervention 
implementation phase, the RA will immediately contact the PI. The PI will then 
immediately assist participants (in their native Nepali language) and help them connect to 
mental health support services available in the area in coordination with the field 
supervisor. The field supervisor will provide the necessary support to them for setting up 
their appointment with primary health care providers if needed. The field supervisor will 
also make a follow-up home visit to monitor their mental health condition, as necessary.  
 Finally, all participants will be asked to contact the PI directly if they have any health 
concerns and/or need help during the intervention implementation phase. We would like to 
identify field supervisors as an alternative contact person for participants and research 
assistants if the Principal Investigator (PI) is busy or unavailable, for whatever reason 

 
35 
 
needed. We plan to recruit two field supervisors from the Bhutanese community. Both are 
trained as community health workers and have extensive experience in providing various 
health services (including referral for mental health problems), as they are part-time 
employees of local level non-profit organizations (e.g., Ascentria Care Alliance) and the 
MA Department of Public Health. Both of them have worked with the PI in previous 
church and family-based mental health intervention studies with depressive and suicidal 
ideation outcomes. They are familiar with available mental health support services 
available in the community and have been providing care and support to the community 
members in a mental health crisis, bearing the dual responsibility of community leader and 
church pastor. Field supervisors will make regular follow-up visits to monitor participants’ 
mental health conditions. A pamphlet will be provided to participants who need additional 
help, which describes the community's psychological services. We handled such cases 
successfully when we conducted our previous three studies, all of which included needs 
assessments, church-based and family-based mental health promotion interventions, 
measured suicidal ideation and depressive symptoms, and utilized our well-established 
networks in the clinical and community settings.   
 
8 
INTERVENTION DISCONTINUATION  
This study included behavioral intervention, which does not have any noted harm. Even 
though subjects may withdraw voluntarily from participation in the study at any time and 
for any reason. Participants should continue to be followed for outcomes, with their 
permission, even if the study intervention is discontinued. The replacement of subjects will 
not be made for those who withdraw or discontinue their participation in the study. RAs 
will collect safety data on any subject discontinued due to adverse events or serious adverse 
events and will be given appropriate care under medical supervision until the symptoms of 
any adverse events resolve or the subject’s condition becomes stable. If voluntary 
withdrawal occurs, the subject will be asked to continue scheduled evaluations and 
complete an end-of-study evaluation. In any case, every effort will be made to undertake 
protocol-specified safety follow-up procedures.  
 

 
36 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 Sample Size and Randomization 
The pilot project aims to estimate the magnitude of the difference between the preventive 
intervention and the education control on the primary outcomes of interest (stress, anxiety, 
depressive symptoms) to inform the design of a large-scale intervention. A study 
comparing PMP to a treatment-as-usual control in Pakistan61 found a mean difference of 
about 7 points with a standard deviation of 8.5 on a measure of anxiety and depression for 
effect size (ES=.86). We do not expect our ES to be as large as what was observed in the 
Pakistani study61 given that we are doing a prevention trial and not an intervention study in 
a distressed population so that this study will provide an estimate of the ES of PMP as a 
preventive intervention.  
We conducted a power analysis to detect an ES as small as ES=.30 with alpha = .05 and 
power of .80. We may find a larger effect in our pilot, but our understanding is that power 
estimates should be based on the smallest effect that we want to detect rather than the size 
of the effect that we expect.62 We expect that families will average approximately 2-4 adult 
persons based on our pilot data, and conducted our power analysis to account for the 
correlation among family members. Analyses were conducted using Optimal Design,63, 
which is power analysis software created for cluster randomized trials such as the present 
study. Accounting for the intra-correlation among family members of .10 and alpha = .05, 
we would have 80% power to detect a standardized difference of ES=.30 between two 
treatment groups of 116 families (58 per treatment arm) with an equal probability of being 
randomized to each of our two intervention arms.  
As noted above, we do not expect our ES to be as large as in the Pakistani study, but a 
sample of that size should be sufficient to provide the estimates of the differences between 
the conditions (with standard deviation in our sample) and the correlations between the 
targets specified by theory and our primary outcome of interest to inform the design of a 
larger-scale controlled trial. The other goal for the project is to determine whether the 
intervention affects the target mechanisms specified by theory to mediate or moderate the 
intervention's impact on the outcomes. Those estimates we will get from the correlation 
between our respective targets (coping and self-efficacy) and the primary outcomes.   
 

 
37 
 
9.2 Data Analyses 
Baseline and follow-up data will be entered into an Excel database and exported to SAS 
statistical package for analyses. Privacy and security rules will be applied to protect the 
confidentiality and security of the data. Security features will be used at multiple levels, 
including the data element, user, application, and hosting services, with password 
protection for data access monitoring. These features will ensure control of access, 
authentication of users, and transmission security. The field team will be trained in project 
data maintenance.  
 
Aim 2a Feasibility assessment: The PMP provides specific guidelines for evaluating and 
monitoring the intervention that we will use to monitor intervention delivery's fidelity. 
These tools are PMP Quiz, PMP Helper’s Supervision Form, PMP Helper Classroom-based 
Competency Assessment, PMP Helper In-field based Competency Assessment, PM+ 
Trainer/Supervisor Competency Assessment, and Session-by-Session Checklists for PMP 
Helpers. Using these standard tools, we will evaluate session-by-session classroom and in-
field based competencies of participants, community trainers, and supervisor and provide 
them feedback as needed using supervision forms, role-plays, group discussion, and 
training.  
Community field supervisors will collect data on eligibility, recruitment and enrollment, 
intervention session attendance (including reasons for missed sessions), and compliance 
with data collection procedures, including hair sample collection and anthropometric 
measurements using a checklist. They will monitor intervention sessions using WHO 
standard checklists. Items include adherence to the manual, percent of intervention content 
administered, proper use of time/materials, and adequate response to participants' 
questions. They will also collect data on engagement, acceptability, and satisfaction via 
brief questionnaires and focus group discussions (FGD) with participants and 
interventionists after each session and upon intervention completion. The PI will conduct 
FGD in the Nepali language with interventionists, supervisors, and participants separately 
to collect information on barriers and facilitators of intervention, perceptions about whether 
the intervention met participants' needs, and feedback on how effectively the program team 
worked with participants. Interviews and FGD will be documented verbatim in a written 
transcript for subsequent analysis. All qualitative data will be analyzed using thematic 

 
38 
 
content analysis.53 Feedback provided by the field staff will be reviewed and coded to 
identify recurrent themes regarding the intervention's acceptability. All analyses will be 
conducted in the Nepali and translated into English. Fidelity data will be used to assess 
intervention content and transmission. We will determine retention by obtaining 
proportions of participants attending all or portion of sessions. 
Aim 2b Intervention efficacy: We will carry out data management and descriptive 
analyses for study outcomes. Means, standard deviations, and percentile distributions will 
be used to describe the continuous baseline variables. Frequencies and percentages will be 
used to describe categorical variables. We will compare baseline characteristics of 
intervention and control groups using chi-square and t-tests as appropriate. While 
differences between groups are not expected because of the randomization used in the 
study design, variables showing significant differences between the two groups will be 
included as covariates in primary analyses. We will compare participants' characteristics to 
follow-up to those with complete data to assess potential limitations in recruitment and 
retention.  
The primary analyses will test whether participants' outcomes in the PMP-I arm differ 
from those in the control arm. Multilevel modeling will compare outcomes of each 
treatment arm while accounting for the clustering of participants within families. 
Continuous outcomes will be analyzed using hierarchical linear modeling, and 
dichotomous outcomes will be analyzed using multilevel generalized linear models with a 
Bernoulli distribution appropriate to nonlinear binary outcomes.64 We expect 
approximately 2-4 members for each of the 58 families in each treatment arm, and the 
correlation among family members' responses will be accounted for in the model. 
Hierarchical or multilevel modeling is suited to these data as it accounts for the clustering 
of members within families and unbalanced designs (i.e., different family sizes).64 This will 
be an intention-to-treat type of analysis, as multilevel modeling allows retention of all 
participants irrespective of the number of sessions attended (multilevel modeling uses 
maximum likelihood estimation, one of the recommended ways of handling missing data). 
The analysis will estimate endpoint outcomes based on repeated measures (Level 1) within 
individuals (Level 2) within families (Level 3). This three-level model is represented by the 
following equations:   

 
39 
 
Level 1: Outcomeijk= πojk + π1jk*Timeijk + eijk ;    Level 2: π0jk = β00k + r0jk ; π1jk = β10k + r1jk  
Level 3: β00k =γ000+ γ001*PMP-Ik + u00k ; β10k =γ100+ γ101*PMP-Ik + u10k 
Where the outcome is measured at each repeated measure i for each individual j within 
each family k. Time is centered at the endpoint, so that β00k estimates the value of the 
outcome for each family at the end of the study, informed by all data points available for 
that family. If an endpoint observation is missing due to drop out, the advantage of 
multilevel modeling is that it utilizes maximum likelihood estimation, which estimates the 
expected outcome for that cluster using information from prior assessments as well as the 
expected value from the entire model. The key test of difference in the outcome between 
the treatment groups is represented by γ001 (in bold); this is a test of difference in outcome 
at endpoint between families randomized to PMP versus not. We expect this test of 
difference to be statistically significant based on our power analysis for the difference in 
outcome level at the endpoint. Note that this model will also test group differences in 
change in each outcome (γ101). While our pilot is not powered for the significance of 
effects of change over time, we will be able to obtain estimates of ES for change for use in 
future larger-scale trials and analyses.     
The ultimate goal of our analyses is to estimate the ES for this prevention trial for each 
outcome, to inform our planning of a full-scale trial. As noted earlier, we have powered this 
pilot prevention trial with a conservative estimate of effect size based on a similar study in 
a clinical population, but no known studies have characterized the precise effect size of 
PMP as a preventive intervention; a goal of our pilot is to estimate the expected effect on 
the population of interest (i.e. an at-risk vs clinical population). All analyses will be 
performed using SAS, version 9 (SAS Institute Inc, Cary, NC). 
 
Aim 2c Mediating effects: Separate models will be created to evaluate the relationships 
between mediators (targets) and outcomes and to 
explore mediators (e.g. coping) of intervention-
outcome relation.  
In this aim, we aim to test the potential mediators 
of the treatment-outcome association by conducting 
mediational analyses in a multilevel regression framework.65 Following current 

 
40 
 
recommended best practices in mediational analysis, we will conduct these analyses using 
recommended practices for mediation with a multilevel framework. 66-68 
Figure 1 provides a visual representation of our proposed analyses, in which treatment is a 
predictor of treatment targets or mechanisms (i.e. the mediators such as coping), which are 
in turn associated with outcomes. As reviewers 1 and 3 note, in mediational analyses, 
variables must be measured in temporal sequence.  
Figure 2 provides a visual representation of our proposed temporal sequence of variable 
measurement for mediational analyses, in which treatment randomization occurs before 
mediator target measurement, which in turn are collected before the outcome measure used 
in the proposed analyses. Second, it is crucial to test the indirect effect (a*b paths) of the 
treatment on the outcome 
through the hypothesized 
mediators. As the indirect 
effect is not normally distributed, we will assess its significance via Monte Carlo simulated 
confidence intervals, which are the recommended counterpart in multilevel mediation to 
bootstrapped confidence intervals used in single-level analyses.66-68 
Each potential mediational sequence will be tested in this manner (see Table 1 for 
mediators and outcomes to be tested). While we acknowledge that mediational analyses are 
difficult to adequately power in a sample of our proposed size,67 we believe these 
preliminary analyses will help identify potential mechanisms for our treatment effect. If 
baseline differences in treatment groups are found in either the mediating or outcome 
variables, baseline measures will be controlled for in 
all analyses. Sample mixed-format multilevel 
equations are provided below, where the nesting of 
measures (i) within families (j) is accounted for by 
the random effects u0js: γ01 in the Mediator equation 
is the ‘a path’, and γ10 in the Outcome equation is the ‘b path.’ 
T2Mediatorij = γ00_Med + γ01_Med*TreatmentConditionj + u0j_Med + rij_Med 
T3Outcomeij = γ00_Out + γ10_Out* T2Mediatorij + γ01_Out*TreatmentConditionj + u0j_Out + rij_Out 
The key estimates are the association of the treatment condition with the mediator (γ01_Med, 
a path) and the association of the T2 mediator with the T3 Outcome (γ10_Out, b path). 

 
41 
 
Multiplied together, these coefficients form the indirect effect of the treatment on the 
outcome and are tested for significance via Monte Carlo simulated confidence intervals. All 
analyses will be performed using Mplus, version 8.69 
 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
10.1.1 Survey Questionnaire: Trained community research assistants will collect information 
from participants using attached screening and survey questionnaires and instruction sheets 
to measure blood pressure, body weight, height, and waist circumferences, and hair 
samples collection. PI will provide two full days of training to RAs on all aspects of the 
study procedure, including recruitment procedure, informed consent, screening, pre, and 
post-assessment survey tools using a questionnaire, anthropometric and blood pressure 
measurement, hair sample collection and storage procedure, logistics materials, and 
administrative details. Training sessions include document review, role-play, and practice 
exercises. We plan to recruit the RAs who worked in our pilot studies to conduct surveys, 
measure anthropometric parameters and blood pressure, and collect hair samples. The 
quality of their data collection was excellent in our previous baseline and pilot intervention 
studies. RAs will complete required human subject research training, including the 
Collaborative Institutional Training Initiative (CITI) and Good Clinical Practice (GCP). 
 
10.1.2 Screening tool: Trained RAs will use the Patient Health Questionnaire (PHQ-9), a 
screening questionnaire for depression, to screen the study participants and record each 
screened participant in the screening log. 
 
 
10.1.3 Survey questionnaire: Trained RAs will use the survey questionnaire, including various 
validated scales to measure stress, anxiety and depressive symptoms, coping, social 
support, social networking, family conflict resolution, and family satisfaction to collect 
information from the participants at baseline, post-intervention, and 3-month post-
intervention. These tools have high internal consistency among the Bhutanese population in 
our pilot studies (Cronbach’s alpha range 0.78 – 0.94).39 
 

 
42 
 
10.1.4 Body measures: Trained RAs will follow standard procedures mentioned in the “Training 
Manual for Research Assistant” to measure blood pressure, body weight, height, and waist 
circumferences of study participants. 
 
10.1.5 Hair samples collection: Trained RAs will follow standard procedures mentioned in the 
“Training Manual for Research Assistant” to collect hair samples of study participants for 
the stress biomarker measurement. Hair samples will be cut from the posterior vertex of the 
scalp, carefully placed in aluminum foil, and stored at room temperature until delivery to 
Dr. Meyer’s laboratory at the University of Massachusetts Amherst. Each sample will be 
cut to a length of 3 cm (if available) from the root (scalp) end and then processed into the 
Dr. Meyer’s laboratory. Briefly, cut samples will be washed twice in 1 ml of isopropanol to 
remove external contaminants, including cortisol deposited on the outside of the hair shaft 
from sweat and sebum. After drying overnight, samples will be ground to be fine powder 
using a bead mill. 1.5 ml of methanol will be added to each sample, after which the 
samples will be subjected to slow rotation for 18-24 hours to extract the cortisol. 1.0 ml of 
the extract will be transferred to a clean tube, dried down using a vacuum evaporator, and 
then reconstituted in 0.25 ml of assay buffer. Reconstituted extracts will be spin-filtered to 
remove any residual particulate matter and then frozen at -20C for later assay. The cortisol 
content of each sample will be analyzed in duplicate along with standards and quality 
controls using the Arbor Assays commercial ELISA kit. Finally, the assay readout will be 
converted to pg cortisol per mg hair weight. 
 
10.1.6 Confidentiality of participants’ information and record: All interviews will be 
conducted with the utmost privacy and confidentiality. Each interested adult participant in 
the family will be interviewed individually, in a private place where they feel comfortable, 
by our trained community RAs who have worked with the PI in previous intervention 
studies. The RAs will ensure audio and visual privacy at these sites and ensure data 
confidentiality. The RAs will assure each participant that their information will be kept 
confidential and not shared with anybody, including family members, in any context. 
Moreover, community interventionists will present the PMP-I interventions in family 
settings welcoming the participation of all interested family members, including parents 

 
43 
 
and young (<18 years) and old children (aged 18 years and above), without revealing 
individual participant’s data and mental health status.  
Furthermore, the RAs will explain the confidentiality procedure in detail before 
collecting any data. The RA will share the following guidelines to maintain subject 
privacy: we will use a numeric code in place of names in all records to ensure 
confidentiality. The survey materials will be stored in a locked cabinet in the PI’s office. 
Only the PI will have access to the cabinet’s key. Data entry will be performed on the PI’s 
office computer (encrypted and password protected) under the full supervision of the PI. 
All original data will be kept in Box, a secure, networked UMass Amherst data storage 
system. Study folders will only be accessible by the PI and through the secure on-campus 
network. De-identified data sets will be used for statistical analyses. Summary data and 
analysis results will be stored on the PI’s UMass office computer or the Box network. The 
PI herself will do data analysis and documentation.  
Data will only be presented in aggregate form in manuscripts or conference abstracts, 
and no individual respondent will be identified. The questionnaires, transcriptions, and 
field notes will be kept separate from identifying informed consent and ID information. 
The master list of participants will be kept under a locked cabinet with access limited to the 
PI. 
 
10.2 Data Management, Analysis, and Quality Assurance 
Baseline and follow-up data will be entered into an Excel database and exported to SAS 
statistical package for analyses. Privacy and security rules will be applied to protect the 
confidentiality and security of the data. Security features will be applied at multiple levels, 
including the data element, user, application, and hosting services, with password 
protection for data access monitoring. These features will ensure control of access, 
authentication of users, and transmission security. The field team will be trained in project 
data maintenance.  
 
10.2.1 Data Safety 
Several precautions will be taken to minimize the unintended risk of disclosure of personal 
information. The protection of data for this study includes the following steps: 

 
44 
 
• Before conducting the fieldwork, the study protocol and survey measures will be 
submitted to the Institutional Review Board at the University of Massachusetts Amherst. 
The study will be initiated only after obtaining approval. All the study members will 
complete the Good Clinical Practice (GCP) and Collaborative Institutional Training 
Initiative (CITI) Course in the Protection of Human Research Subjects – online training 
in research ethics - to ensure that all personnel is compliant with confidentiality training. 
• All information collected during the study will remain confidential. Interviewers will 
reassure participants that numerical codes would be used in place of names in all records 
to ensure confidentiality. The survey materials (questionnaires, transcriptions, and field 
notes) will be stored in a locked cabinet in the PI’s office. Only the PI will have access 
to the cabinet’s key. Data entry will be done on the PI’s office computer (encrypted and 
password protected) under the full supervision of the PI. The original data will be kept 
on Box, a secure, networked UMass data storage system, after fieldwork. The folders 
will only be accessible by the PI through the on-campus network. De-identified data sets 
will be used for statistical analyses. Summary data and analysis results will be stored on 
the PI’s UMass office computer or the Box network. The PI herself will do data analysis 
and documentation. Data presented will not include the names of any individuals. All 
information will be presented in aggregate form in the manuscript or conference 
abstract, and no individual respondent will be identified. The PI will take responsibility 
for destroying questionnaires and hard copies of study documents using a paper cutting 
machine five years after completing data analysis, documentation, and publication. 
• Participant information, including name and contact information, will be collected on 
form separate form from study data at enrollment. Later, this information will be saved 
in a password-protected file on the PI’s office computer. The study identification 
number or code number assigned to each participant will be retained in the data stored at 
UMass Amherst. All hard copies will be stored in the locked file cabinet in a locked 
office and electronic information on the PI’s computer using an encrypted and 
password-protected file. Only the PI will have access to this information. The Master 
List linking participant ID numbers with identifying information will be destroyed after 
the completion of data analysis. 
• All data stored in computer files will be encrypted and password protected.  

 
45 
 
• After the fieldwork, only one set of cleaned data set will be maintained. The file will be 
kept on a secure UMass data storage system. The folders will be accessible only by the 
PI through the on-campus network. Summary data and analysis results may be stored on 
the UMass office network M drive. These files will be removed from the network drive 
five years after the completion of data analysis, documentation, and publication. 
 
10.2.2 Validity and Integrity 
The PI and University of Massachusetts undergraduate RA will monitor the validity and 
integrity of the data on an on-going basis. The PI and RA will have online meetings every 
other week with the investigators, and alternate between online and in-person meetings 
every week with field-team members (community interventionist, field supervisors, and 
research assistants) throughout the data collection and intervention period, to review the 
accuracy, quality of the data, coding of data collected, monitoring of protocol, ongoing 
training, and problem-solving. The PI will meet regularly with the RA to ensure that data 
are processed appropriately. The study investigators will closely supervise the field-team 
to maintain quality.  
 
10.2.3 Quality Control Procedures 
This manual of operations and procedures has included details of the study procedures to 
ensure that procedures are implemented correctly and consistently to monitor intervention 
fidelity. Copies of this study manual will be kept at the University of Massachusetts 
Amherst, Vanderbilt University, Tennessee, and the study site. All field-team members 
will undergo thorough training regarding study procedures, including the Protection of 
Human Research Subjects and Good Clinical Practice. Retraining will be done as 
necessary. 
Quality assurance of data entry consists of proactive tools that are implemented to 
increase the quality of data processing components. Specifically, these include form 
design to avoid missing; training of research assistants on the study forms so that they are 
familiar with the required responses; design of the data entry forms; specifications of the 
data fields to reflect the nature of the data to be entered; specification of the edit 
parameters and checking algorithms so that every area is verified as thoroughly as 

 
46 
 
possible; and validation of the database system to certify that data entered into the data 
entry screens are accurately recorded in the databases. 
For data quality assurance measures, we will conduct training of the RAs on data 
collection techniques with periodic retraining and immediate review of data collection to 
be sure that data collection forms are fully complete. 
For data quality control measures, we will conduct regular analyses to investigate: the 
number of missing data items; the number and type of forms that are failing edit; and the 
distribution of data to identify outliers. 
 
 
10.2.4 Data Sharing 
Data from the study will be shared via the National Database for Clinical Trials (NDTC) 
related to Mental Illness. For this study, we will assign a global unique identifier (GUID) 
to each participant. This GUID is generated as a subject ID that allows researchers to 
share data specific to a study participant without personally identifying identifiable 
information. The GUID comprises random alpha-numeric characters and is NOT 
generated from personally identifiable information or protected health information.  
Descriptive/raw data will be submitted semi-annually. Access to raw data used in the 
project will be considered for sharing compliance with the NIH Grants Policy on Sharing 
Unique Research Resources. Any raw data to be released for sharing will not contain 
identifiers of the study participants. Data will be made available to users undersigned and 
properly executed data-sharing agreements, which stipulate the criteria under which data 
may be used. Criteria include a commitment to using data for research purposes only, 
commitment to not identifying individual participants, commitment to securing data 
using appropriate technology, and commitment to destroying or returning data after 
analyses are completed.  
All other data will be submitted at the time of publication or before the end of the 
grant, whichever occurs first. Investigators will share positive and negative results 
specific to the outcome measures studied by using the study functionality. Investigators 
will certify all data quality before submission to NDTC and review data for accuracy 
after submission. Information about this plan will be included in the informed consent 
forms in plain language.  

 
47 
 
 
 
10.2.5 Protocol Deviations 
The PI will strictly monitor field staffs’ protocol compliance while implementing 
different activities, such as participant enrollment and randomization, intervention 
compliance, and data collection through onsite supervisions and phone conversations 
with field staff and participants, including review of records, consent forms, and fidelity 
monitoring forms using attached protocol deviation log to document them.

 
48 
 
PROTOCOL DEVIATION LOG 
Protocol Name:________________________________________________________________________ 
 
Protocol 
Deviation Code: 
Participant Initials 
Participant 
ID# 
Date Deviation 
Occurred: 
mm/dd/yyyy 
Date Protocol 
Deviation Form 
Completed: 
mm/dd/yyyy 
Contact Person 
(if applicable) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL DEVIATION CODES  
 
 
Consent Form: 
7. Missing or not obtained 
8. Not signed and dated by participant 
9. Does not contain all required signatures 
10. Outdated, current IRB-approved version not used   
11. Not protocol-specific 
12. Does not include updates or information required by the IRB 
Randomization: 
13. Ineligible participant enrolled and/or randomized 
14. Participant randomized prior to determining whether 
eligible for study  
15. Occurs outside protocol window 
IRB: 
16. Not reporting a serious complication within 24 hours; 
17. Approvals not kept up to date 
18. Enrollment and/or treatment occurs prior to IRB approval or 
during period when on “on hold” 
19. Reportable serious adverse events not reported to IRB 
Participant 
1. Receives wrong treatment 
2. Visits occur outside expected follow-up window  
3. Entered into another study 
Study Data and/or Forms 
4. Missing data and/or forms 
5. Missing hair samples 
6. Forms or data not sent from RAs to field supervisor 
 

 
49 
 
   
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
The study protocol and the informed consent document, and any subsequent modifications 
will be reviewed and approved by the UMass Amherst IRB.  
 
11.2 Informed Consent Forms 
Consent forms will be Institutional Review Board (IRB)-approved, and the participant will 
be asked to read and review the document. The RAs will explain the research study to the 
participant and answer any questions that may arise. A verbal explanation will be provided 
in terms of the participant’s comprehension of the purposes, procedures, and potential risks 
of the study and their rights as research participants.  Participants will be informed that 
participation is voluntary and that they may withdraw from the study at any time, without 
prejudice, and that the quality of their medical care and other supports will not be adversely 
affected if they decline to participate in this study. Participants will have the opportunity to 
carefully review the written consent form and ask questions before signing. The informed 
consent process will be conducted and documented in the source document (including the 
date), and the form signed before the participant undergoes any study-specific procedures.  
 
11.3 Participant Confidentiality  
All interviews will be conducted with the utmost privacy and confidentiality. Each 
interested adult participant in the family will be interviewed individually, in a private place 
where they feel comfortable, by our trained community RAs who have worked with the PI 
in previous intervention studies. The RA will ensure audio and visual privacy at these sites 
and ensure data confidentiality. The RA will assure each participant that their information 
will be kept confidential and not shared with anybody, including family members, in any 
context. Moreover, we will present our interventions in family settings welcoming the 
participation of all interested family members, including parents and young (<18 years) and 
old children (aged 18 years and above), without revealing individual participant’s data and 
mental health status.  
Furthermore, the RA will explain the confidentiality procedure in detail before 

 
50 
 
collecting any data. The RA will share the following procedures to maintain subject 
privacy: we will use a numeric code in place of names in all records to ensure 
confidentiality. The survey materials will be stored in a locked cabinet in the PI’s office. 
Only the PI will have access to the cabinet’s key. Data entry will be performed on the PI’s 
office computer (encrypted and password protected) under the full supervision of the PI. 
All original data will be kept in Box, a secure, networked UMass Amherst data storage 
system. Study folders will only be accessible by the PI and through the secure on-campus 
network.  
De-identified data sets will be used for statistical analyses. Summary data and analysis 
results will be stored on the PI’s UMass office computer or the Box network. The PI herself 
will do data analysis and documentation. Data will only be presented in aggregate form in 
manuscripts or conference abstracts, and no individual respondent will be identified. The 
questionnaires, transcriptions, and field notes will be kept separate from identifying 
informed consent and ID information. The master list of participants will be kept under a 
locked cabinet with access limited to the PI. 
The hair sample will be stored in a clean, dry aluminum foil with your ID number on 
top of the aluminum envelope. The hair samples will be stored in the College of Nursing’s 
laboratory during the data collection process. At the end of the survey, the collected hair 
samples will be sent to the laboratory in UMass Amherst. Hair samples will be processed in 
the laboratory for cortisol measurement. If the sample remains after measurement 
procedure completion, it will be disposed of according to the laboratory's safety rules and 
regulations. 
For this study, each participant will be assigned a global unique identifier (GUID). This 
GUID is generated as a subject ID that allows researchers to share raw data such as 
numbers or percentages specific to a study participant without exposing personally 
identifiable information. The GUID comprises random alpha-numeric characters and is 
NOT generated from personally identifiable information or protected health information. 
This identifier will be kept separate from your paper consent file and stored in a password-
protected electronic file. Descriptive/raw data will be submitted semi-annually. Access to 
raw data used in the proposed project will be considered for sharing compliance with the 
NIH Grants Policy on Sharing Unique Research Resources. Any raw data to be released for 

 
51 
 
sharing will not contain identifiers (such as name, address, birth date, and phone number) 
of the study participants.  
We will send de-identified study data to the National Institute of Mental Health Data 
Archive (NDA) during and after the study. Experts at the NIH who know how to keep 
participant’s data safe. The study researchers will make every attempt to protect 
participant’s identities. The study data provided to NDA may help researchers worldwide 
learn more about mental health and help others who have mental health problems. NIMH 
will also report to Congress and on its website about the different studies using NDA data. 
The participant will not be contacted directly about the study data they contributed to NDA. 
During the study, the participant can decide that they do not want their study data to be 
added to the NDA. The participant can still participate in this research study even if they 
decide that they do not want their data to be added to the NDA.  
A Certificate of Confidentiality covers this research from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, 
documents, or hair samples that may identify participants in any federal, state, or local 
civil, criminal, administrative, legislative, or other actions.  
A description of this study will be available on http://www.ClinicalTrials.gov. This 
Web site will not include information that can identify the participant. At most, the Website 
will consist of a summary of the results when they are available. The participant can search 
this Web site at any time. The registration number for this study is NCT04453709. 
 
11.4 Confidentiality Limits 
We will keep all information from participants confidential. There are certain exceptions to 
this rule, as permitted by law and professional ethics. Our experience is that these 
exceptions will arise infrequently. They will include: a) We may disclose confidential 
information when we judge that there is a strong possibility of serious harm being inflicted 
by a participant on another person or themselves, and we are unable to develop a plan with 
the participant to ensure safety; b) Should a participant disclose information relating to 
probable child abuse, elder abuse, or abuse of a vulnerable adult (for example, someone 
who is developmentally disabled or mentally ill, or who has a disabling illness), we may be 
required to notify state authorities.  

 
52 
 
 
11.5 Study Discontinuation  
The study may be discontinued at any time by the UMass Amherst IRB or National 
Institute of Mental Health as part of their duties to ensure that research participants are 
protected.  
 
12 
ETHICAL CONSIDERATIONS 
The study protocol is approved by the Institutional Review Board (IRB) of the University 
of Massachusetts Amherst. Working in partnership with the UMass research community, 
the Human Research Protection Office (HRPO) and the IRB are responsible for protecting 
research participants' rights and welfare. Guided by the principles outlined in the Belmont 
Report: Ethical Principles and Guidelines for the Human Subjects of Research (link is 
external), the HRPO strives to ensure that research is conducted under the auspices of the 
University of Massachusetts Amherst complies with all federal, state, and local regulations. 
 
13 
PUBLICATION OF RESEARCH FINDINGS 
Publications of this trial's results will be governed by the policies and procedures 
developed by the National Institutes of Health.  Any presentation, abstract, or manuscript 
will be made available for review by the National Institutes of Health before publications. 
The peer-reviewed article accepted for publication will be submitted to the NIH Manuscript 
Submission System to receive the PMCID number. Progress reports will include PMCID 
reference numbers when citing applicable papers authored or arising from NIH-funded 
research.  All publications will be entered into the PI’s MyNCBI account using the 
bibliography management tool My Bibliography.   
 
 
 

 
53 
 
 
14 
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