Implementing and Evaluating a Wellness and Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic: EMPOWER (Emotions Program Outside the Clinic and Wellness Education for Refugees)
Phase: NA
Conditions: Social Emotional Wellness
Sponsor: Yale University

 
 
February 20, 2022, Version 3 
Implementing and Evaluating a Wellness and Social-
Emotional Learning Program for Refugee Children 
During the COVID-19 Pandemic: EMPOWER 
(Emotions Program Outside the Clinic and Wellness 
Education for Refugees) 
Protocol Number 
2000030455 
ClinicalTrials.gov Identifier: NCT04931888 
 
  
Protocol and Statistical Analysis Plan 
February 20, 2022 
 Version #3 
 
 
 
 
 

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Synopsis 
Purpose 
Our overall goal is to pilot an adaptation of an established Social-Emotional Learning 
(SEL) Program with novel wellness and COVID-19 safety components that are trauma-
informed and culturally-specific in a resettled refugee community. 
Objectives 
In this pilot, “EMPOWER” (Emotions Program Outside the clinic and Wellness Education 
for Refugees), we aim: 
1. To assess implementation outcomes (adoption, acceptability, and feasibility) of 
EMPOWER with refugee children and families during the COVID-19 pandemic 
through longitudinal evaluations and measurements of feasibility, acceptability, and 
attrition.  
2. To evaluate the impact of EMPOWER by assessing (a) children’s SEL competence 
and (b) children’s and family’s COVID-19 knowledge. 
Study Population 
The study population will include families who are connected with Elena’s Light, a trusted 
community non-profit organization that supports refugee families in the New Haven 
region.  
Because the model of adaptation and delivery will be culturally specific for Afghan 
refugees (the majority of recent refugees in the New Haven area are from Afghanistan), 
eligible participants will include Afghan refugee children, 5-15 years old, who have 
completed ≥1 year of school in US. One parent/guardian will also be surveyed in the pre- 
and post-evaluation on Zoom. 
Number of Participants 
A total of approximately 75 children from 30 family units will be recruited to participate, 
along with at least one parent/guardian from each family. This will include 50 children from 
20 family units in the intervention group and 25 children form 10 family units in the control 
group.  
Study Design 
The overall objective of this study is to establish and evaluate the preliminary 
efficacy and implementation of an adapted social-emotional learning (SEL) and 
Wellness Program for refugees: EMPOWER (Emotions Program Outside the clinic 
with Wellness Education for Refugees). To achieve the two aims of this study, the 
study team will conduct a wait-list controlled pilot to establish and evaluate the 
preliminary efficacy of participation in EMPOWER by assessing (a) children's SEL 
competence and (b) measures of mental health, stress, quality of life and wellness 
before and after participation in the program (Aim 1). Then, the study team will 
assess the implementation of EMPOWER with refugee children by using mixed 
methods to perform a summative evaluation of implementation outcomes-including 
fidelity, sustainability, and reach-in the Afghan refugee community (Aim 2). 
 

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Study Duration 
The EMPOWER curriculum will initiate with recruitment and enrollment beginning May 1, 
2022 with program initiation occurring approximately 2-3 months after recruitment and 
enrollment initiation, and analysis occurring approximately 2-6 month after initiation. Data 
analysis is planned for until approximately two years after initiation. 
Outcome Variables 
Implementation outcome measures will include feasibility, attrition, and parent and child 
acceptability, measured via post-intervention qualitative evaluations of parents. 
Preliminary efficacy primary outcome measures will include COVID-19 knowledge and 
Social-Emotional Competence, measured via evaluation of symptoms and the Trait Meta-
Mood Scale, respectively. Secondary outcomes will be measured using the Pediatric 
Quality of Life Inventory, Perceived Stress Scale, and the Afghan Symptom Checklist.  
Locations/Facilities 
Sessions will occur in Connecticut, USA, in safe outdoors spaces (e.g., parks, roped-off 
parking lots) within walking distance of family homes and on Zoom (with the ability to 
covert to 100% Zoom if needed because of weather and/or COVID-19 restrictions). Pre- 
and post- evaluations will occur on Zoom. 
 
 
 

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Abbreviations 
Abbreviation  
Explanation 
CASEL 
Collaboration for Academic Social and 
Emotional Learning 
EMPOWER 
Emotions Program Outside the clinic with 
Wellness Education for Refugees 
PSC 
Pediatric Stress 
PEDS-QL 
Pediatric Quality of Life Inventory 
SEL 
Social-Emotional Learning 
TMMS 
Trait Meta Mood Scale 
 
 

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Table of Contents 
Synopsis ..................................................................................................................................... 2 
Purpose .................................................................................................................................. 2 
Objectives ............................................................................................................................... 2 
Study Population .................................................................................................................... 2 
Number of Participants........................................................................................................... 2 
Study Design .......................................................................................................................... 2 
Study Duration ........................................................................................................................ 3 
Outcome Variables ................................................................................................................. 3 
Locations/Facilities ................................................................................................................. 3 
Abbreviations ............................................................................................................................. 4 
Protocol Revision History ........................................................................................................... 8 
1 
Background ......................................................................................................................... 9 
1.1 
Background ................................................................................................................ 9 
1.2 
Prior Experience ........................................................................................................ 9 
2 
Rationale/Significance ...................................................................................................... 11 
2.1 
Rationale and Study Significance ............................................................................ 11 
2.2 
Risks......................................................................................................................... 11 
2.3 
Anticipated Benefits ................................................................................................. 11 
3 
Study Purpose and Objectives ......................................................................................... 12 
3.1 
Purpose .................................................................................................................... 12 
3.2 
Hypothesis ............................................................................................................... 12 
3.3 
Objectives ................................................................................................................ 12 
4 
Study Design .................................................................................................................... 13 
4.1 
Study Duration ......................................................................................................... 15 
4.2 
Outcome Variables/Endpoints ................................................................................. 15 
4.2.1 
Primary Outcome Variables/Endpoints ............................................................... 15 
4.2.2 
Secondary and Exploratory Outcome Variables/Endpoints (if applicable) ......... 15 
5 
Study Participants ............................................................................................................. 16 
5.1 
Study Population ...................................................................................................... 16 
5.2 
Number of Participants ............................................................................................ 16 

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5.3 
Eligibility Criteria ...................................................................................................... 16 
5.4 
Recruitment Procedures .......................................................................................... 16 
5.5 
Consent/Assent Procedures/HIPAA Authorization ................................................. 16 
6 
Study Methods/Procedures .............................................................................................. 18 
6.1 
Study Procedures .................................................................................................... 18 
6.1.1 
Data Collection ..................................................................................................... 19 
6.2 
Method of Assignment/Randomization (if applicable) ............................................. 20 
6.3 
Adverse Events Definition and Reporting................................................................ 20 
6.4 
Reaction Management ............................................................................................. 20 
6.5 
Withdrawal Procedures ............................................................................................ 20 
6.6 
Locations/Facilities................................................................................................... 20 
7 
Statistical Design .............................................................................................................. 21 
7.1 
Sample Size Considerations ................................................................................... 21 
7.2 
Planned Analyses .................................................................................................... 21 
7.2.1 
Secondary Objective Analyses (if applicable) ..................................................... 21 
7.2.2 
Analysis of Subject Characteristics (if applicable) .............................................. 21 
7.2.3 
Interim Analysis (if applicable) ............................................................................. 21 
7.3 
Data Relevance ....................................................................................................... 21 
7.4 
Data Coding ............................................................................................................. 21 
7.5 
Data Analysis Tools ................................................................................................. 22 
Both Dedoose and Stata will be used in analysis. ............................................................... 22 
7.6 
Data Monitoring ........................................................................................................ 22 
7.7 
Handling of Missing Data ......................................................................................... 22 
8 
Data/Specimen Handling and Record Keeping ............................................................... 23 
8.1 
Subject Data Confidentiality .................................................................................... 23 
8.2 
Data Quality Assurance ........................................................................................... 23 
8.3 
Data or Specimen Storage/Security ........................................................................ 23 
8.4 
Study Records ......................................................................................................... 23 
8.5 
Access to Source ..................................................................................................... 24 
8.6 
Retention of Records ............................................................................................... 24 
8.7 
Data and Safety Monitoring Plan ............................................................................. 24 

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9 
Study Considerations ....................................................................................................... 25 
9.1 
Institutional Review Board (IRB) Review................................................................. 25 
9.2 
Research Personnel Training .................................................................................. 25 
9.3 
Study Monitoring ...................................................................................................... 25 
9.4 
Unanticipated Problems and Protocol Deviations ................................................... 25 
9.5 
Study Discontinuation .............................................................................................. 26 
9.6 
Study Completion ..................................................................................................... 26 
9.7 
Conflict of Interest Management Plan ..................................................................... 26 
9.8 
Funding Source ........................................................................................................ 26 
9.9 
Publication Plan ....................................................................................................... 26 
10 
List of Tables ................................................................................................................ 27 
 
 
 
 

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Protocol Revision History 
 
Version 
Date 
Summary of Substantial Changes 
February 
20, 2022 
• 
Increase age range of study population from 6-14 to 5-15 
• 
Remove randomization from study design 
• 
Afghan Symptom Checklist added and Child Behavioral Health 
Checklist removed 
 
 
 
 

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1 Background 
1.1 
Background 
Refugee children have limited access to timely diagnosis and treatment for mental 
and/or behavioral health (MBH) problems, despite facing multiple risk factors. Children 
in immigrant families face barriers to receiving preventative MBH services and to receiving 
timely diagnoses and treatment. A study of first point-of-contact for mental health conditions 
found that immigrant patients accessed care in the Emergency Department more frequently 
than their non-immigrant peers.1 Using data from the National Survey of Children’s Health, 
we found that, among children who have an MBH diagnosis, those in immigrant families are 
also less likely to receive treatment.2 Refugee children are at additional risk for MBH 
concerns, because many have faced trauma during pre-migration, migration, and post-
migration experiences.3–5 Additional MBH risks are related to potential toxic exposures; for 
example, elevated blood lead levels are common in refugee children depending on age and 
country of origin.6  
In the era of COVID-19, barriers to timely diagnosis and care as well as mental health 
risks have increased, especially for refugee populations. Risk factors during the COVID-
19 pandemic that may exacerbate MBH concerns already faced by refugees include food 
insecurity, inability to social distance, and educational disruptions. Refugees are particularly 
vulnerable to exacerbations of language barriers, isolation, and economic insecurity.7–10 
Despite advances in vaccine development, children will not have early access to COVID-19 
immunizations.11 The ongoing need for mitigation measures, anticipated to continue into 
2022, will likely further exacerbate COVID-19-related barriers and underscores the 
importance of equitable access to timely COVID-19 information and resources.  
Robust evidence supports the value of SEL curricula in multiple domains. A recent 
systematic review and meta-analysis found that, compared with control groups, children who 
participated in SEL curricula demonstrated improvement in social and emotional 
competence, behavioral self-regulation, early learning skills, and social-emotional challenge 
behaviors.12 Specifically, emotional competence—which includes the ability to identify one’s 
own feelings, to identify the feelings of others, and the skills to communicate and cope with 
emotions to guide thinking and actions—is associated with successful school and work 
performances and decreased susceptibility to disease.13–16 
 
1.2 
Prior Experience  
In response to stakeholder-identified concerns related to delayed identification of MBH 
problems and lack of coordinated referrals, we partnered with community members to 
conduct interviews with Afghan refugee parents. From this community-based participatory 
research (Rosenberg, J., Leung, J. K., Harris, K., Abdullah, A., Rohbar, A., Brown, C., & 
Rosenthal, M. S. (2021). Recently-arrived Afghan refugee parents’ perspectives about 
parenting, education and pediatric medical and mental health care services. Journal of 
Immigrant and Minority Health), we learned that many parents had not yet considered or 
reflected on MBH concerns because of higher priority concerns around safety and 
acculturation. Parents described priorities around health that were related to basic safety 
after living in war-torn regions. They described an emerging support system and an 
appreciation for an engaged and connected health system but expressed little trust in 
discussing MBH concerns with medical providers. Based on parents’ identified needs and 
opportunities for engagement, we sought opportunities for education, prevention, and 
engagement with community members. 
In summer 2020, we developed and launched an adaptation of an SEL curriculum, 
“EMPOWER,” with 13 families to establish community trust, determine program feasibility, 

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and to promote public health by disseminating preventative COVID-19 information in 
preferred languages. We analyzed the program after its conclusion by surveying and 
interviewing parents of each participating family. Findings from this analysis, which were 
recently published in Health Education Behavior (Rosenberg, J., McDonough Ryan, P., 
O’Brien, C., Ganjavi, F., & Sharifi, M. (2021). Pilot Wellness Program With Adapted Social–
Emotional Learning and COVID-19 Curriculum for Refugee Youth. Health Education & 
Behavior), suggest that the curricular components are likely to be feasible and acceptable. 
After the program, all 13 parents who participated correctly identified symptoms and 
protective measures for COVID-19 based on a published questionnaire that assessed 
disparities in COVID-19 knowledge.17 Additionally, all  parents responded that the program 
was worthwhile, that they were interested in re-enrollment, and that they would recommend 
EMPOWER to a peer. However, social desirability bias, a small sample, and the lack of a 
comparisons group limit our interpretation of these preliminary results. 
 
 
 
 
 

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2 Rationale/Significance 
2.1 
Rationale and Study Significance  
Despite this robust literature on the value of SEL curricula, no studies, to our knowledge, 
have adapted curricula for refugee populations nor included COVID-19 pandemic safety. In 
this proposed pilot EMPOWER trial, we aim to improve the health and wellbeing of resettled 
Afghan refugee children by implementing and rigorously evaluating our adapted SEL 
curricular program, which is augmented with novel, trauma-informed and culturally-specific 
wellness and safety elements related to the COVID-19 pandemic and its aftermath. 
 
2.2 
Risks 
Risks of the intervention and evaluations may include discomfort or confusion with some of 
the information provided and/or questions asked. Resources will be available for participants 
and family members should any discomfort arise, including direct connections with care 
coordinators, patient navigators, and mental and medical health providers. COVID-19 safety 
measures will be in place in line with CDC guidelines, with symptom screening, physical 
distancing, masking, outdoor-only activities, and emphasis on hygiene and cleanliness, so 
there is minimal risk of COVID-19 exposure based upon these safety measures. 
 
2.3 
Anticipated Benefits 
Benefits for the participants will include access to COVID-19 safety information, access to 
information about social-emotional learning, and nutrition and exercise information, which 
can all contribute to health and wellness. Participants will also receive course materials 
(yoga mats, art materials, cleaning supplies) and gift cards. For society and/or science, the 
benefits will include information about the preliminary efficacy, feasibility, and acceptability of 
social-emotional learning and wellness curricula for refugees. 
 
 
 
 

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3 Study Purpose and Objectives 
3.1 
Purpose 
Our overall goal is to pilot an adaptation of an established Social-Emotional Learning (SEL) 
Program with novel wellness and COVID-19 safety components that are trauma-informed 
and culturally-specific in a resettled refugee community. In this pilot, “EMPOWER” (Emotions 
Program Outside the clinic and Wellness Education for Refugees), we aim: 
 
3.2 
Hypothesis 
The major question that guides this research is: can an adaptation of an established Social-
Emotional Learning (SEL) curriculum effectively improve Social-Emotional wellness for 
refugee children and their families?  
 
We hypothesize that participation in this program will (a) improve children’s SEL competence 
and (b) lessen stress and improve quality of life for refugee families. 
 
3.3 
Objectives 
In this pilot, “EMPOWER” (Emotions Program Outside the clinic and Wellness Education for 
Refugees), we aim: 
1. To assess implementation outcomes (adoption, acceptability, and feasibility) of 
EMPOWER with refugee children and families during the COVID-19 pandemic 
through longitudinal evaluations and measurements of feasibility, acceptability, 
and attrition.  
2. To evaluate the impact of EMPOWER by assessing (a) children’s SEL 
competence and (b) children’s and family’s COVID-19 knowledge. 
 
 
 

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4 Study Design 
Overall Approach: 
The overall objective of this study is to establish and evaluate the preliminary efficacy and 
implementation of an adapted social-emotional learning (SEL) and Wellness Program for 
refugees: EMPOWER (Emotions Program Outside the clinic with Wellness Education for 
Refugees). We will achieve these goals through two aims. We will conduct a wait-list 
controlled,pilot to establish and evaluate the preliminary efficacy of participation in 
EMPOWER by assessing (a) children’s SEL competence and (b) measures of mental health, 
stress, quality of life and wellness before and after participation in the program (Aim 1). 
Then, we will assess the implementation of EMPOWER with refugee children by using mixed 
methods to perform a summative evaluation of implementation outcomes—including fidelity, 
sustainability, and reach—in the Afghan refugee community (Aim 2). 
 
EMPOWER Curriculum: 
EMPOWER is an adapted SEL and wellness education initiative delivered to a community of 
refugee families that was developed through a pre-pilot in the New Haven Afghan refugee 
community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with 
community organizations to provide translated and trauma-informed wellness education to 
family units. The program combines in-person (socially distant) and remote delivery of 
culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-
based behavioral medicine, refugee trauma and recovery, and community health research. 
Over two weeks, enrollees participate in six in-person sessions (two hours each). They also 
complete eight, one-hour, weekly Zoom sessions during and beyond the in-person 
curriculum. At-home Zoom technical support is provided as needed. Each family unit is 
guided through in-person and online components by a facilitator. The EMPOWER curriculum 
focuses on the core competency of self-awareness, a core element of emotional 
competence, from the Collaboration for Academic Social and Emotional Learning (CASEL) 
framework. Facilitators include interns, health-providers, and community partners. We have 
published a detailed EMPOWER manual, which we will iteratively modify, through an online 
request portal.  
Intervention:  
We will use implementation science methods and apply an Intervention Mapping framework 
to refine and assess the adoption, acceptability, and feasibility of EMPOWER.   The program 
will include virtual and in-person SEL, COVID-19 safety, and physical activity instructions. 
Program administrators will also respond to and track disclosure of and/or identification of 
mental health, medical, or other needs. 
Data Collection and Measures:  
We will conduct a mixed methods evaluation—using concurrent qualitative and quantitative 
data collection and merged analysis—to survey parents and their children (over Zoom) at 
early and late time-points of their involvement in the program. Interview guides and survey 

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tools will be developed with community partners and will be based upon previously-studied 
measures used for war-affected families. In addition to demographic covariates (age, 
gender, languages, years in the US), we will collect data and assess implementation 
outcomes as well as primary and secondary outcome measures. Questions will be asked to 
parents about each child and to the children directly. 
Implementation measures (Aim 1) will include assessment of adoption, acceptability, and 
feasibility through parent and stakeholder evaluations and through rates of attrition. 
Outcome measures (Aim 2) will include (a) COVID-19 knowledge, measured via an 
established COVID-19 knowledge assessment and (b) children’s SEL competence, 
measured by the Trait Meta-Mood Scale. Secondary outcomes and covariates will include 
the validated measures that may modify intervention effectiveness. While timeline and small 
sample size in this pilot will likely not allow detection of pre-post differences in quality of life 
or behavioral health concerns such as stress or depressive symptoms, we will examine 
patterns in secondary outcomes to form hypotheses in preparation for future, larger-scale 
trials. 
 
Analysis Plan:  
In this mixed methods study, we will perform concurrent qualitative and quantitative data 
collection and subsequent merged analysis. We will analyze quantitative data in Stata, with 
statistical support from a biostatistician. Qualitative responses will be transcribed and coded 
by members of the research teams using Dedoose. We will identify emerging themes using 
the constant comparative method. A repeated measures linear mixed model approach will 
be used for analysis. The primary analyses will compare changes in COVID-19 knowledge 
and of emotional competence before and after participation between the intervention and 
wait-list control groups. Similar analyses will be measured for secondary outcomes.  
 
 
 
 
 
 
 
 

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4.1 
Study Duration 
The EMPOWER curriculum will be conducted between June 1 and August 31 2022 for both 
the intervention and wait list control groups. Data collection will conclude by October 31, 
2022, with data analysis continuing until August 30, 2023. 
 
4.2 
Outcome Variables/Endpoints 
Outcomes of interest (in Table 1, below) will include (1) implementation outcomes (feasibility, 
attrition, acceptability) and (2) primary preliminary efficacy outcome measures (COVID-19 
knowledge and Social-Emotional Competence). Additional exploratory outcomes of interest 
are related to quality of life, stress, and behavioral health. Measures were chosen based 
upon previously validated measures that can be adapted to other cultures and languages. 
 
4.2.1 Primary Outcome Variables/Endpoints 
As outlined in Table 1, below, primary implementation outcome measures will include 
feasibility, attrition, and parent and child acceptability, measured via post-intervention 
qualitative evaluations of parents.  
Primary preliminary efficacy measures will include COVID-19 knowledge and Social-
Emotional Competence, measured via evaluation of symptoms and the Trait Meta-Mood 
Scale, respectively.  
 
4.2.2 Secondary and Exploratory Outcome Variables/Endpoints (if applicable) 
Secondary outcomes will be measured using the Pediatric Quality of Life Inventory, 
Perceived Stress Scale, and the Afghan Symptom Checklist. 
 
 
Table 1. EMPOWER Outcome Measures, Instruments, and Respondents 
Implementation Outcome Measures (via Qualitative Evaluations): 
Feasibility 
Qualitative evaluation of parents’ challenges 
with feasibility. Community partner 
stakeholders will be involved in this analysis. 
Parents 
Attrition 
Participant attendance & reasons for absence 
Parents  
Parent and Child 
Acceptability 
Qualitative evaluation of (1) parents’ 
experiences (2) child completion of homework 
activities (3)  referrals (for parents and 
children) related to mental, emotional, 
physical or behavioral health 
Parents 
Primary Outcome Measures (via Pre- and Post-Tests): 
COVID-19 Knowledge 
Evaluation of Symptoms and prevention*17 
Parents & Children 
Social-Emotional 
Competence 
Trait Meta-Mood Scale*16 
Parents & Children 
Secondary Outcomes Measures and Covariates (via Pre- and Post-Tests): 
Quality of Life       
Pediatric Quality of Life Inventory (PEDS-QL)*  Parents & Children 
Stress 
Perceived Stress Scale (PSC)*19                        Parents & Children 
Depressive Symptoms 
Afghan Symptom Checklist‡20  
Parents & Children 
Social Problems 
Afghan Symptom Checklist‡20  
Parents & Children 
*To be translated according to World Health Organization Standards.22   ‡Pashto/Farsi translation available. 

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5 Study Participants 
5.1 
Study Population 
Participants will include families who are connected with Elena’s Light, a trusted community 
non-profit organization that supports refugee families in the New Haven region.  
Waitlist control participants will receive written, translated program materials and begin the 
formal curriculum after the intervention group.  
 
5.2 
Number of Participants 
We will recruit a total of 75 children from a total of approximately 30 family units. 
After recruitment, we will assign participants to an intervention group (50 children from 20 
family units) and a wait-list control group (25 children from 10 family units) and will stagger 
administration of the EMPOWER curriculum to the two groups. 
 
5.3 
Eligibility Criteria 
Eligibility will be determined in partnership with our community partner, Elena’s Light, with 
approval by the PI based upon eligibility status.  
• 
Because we are recruiting by family unit, we will allow a wide age range of children, 
from 5-15 years old.  
• 
The model of adaptation and delivery will be culturally specific for Afghan refugees 
(the majority of recent refugees in the New Haven area are from Afghanistan). 
• 
Thus, eligible participants will include:  
o Afghan refugee children 
o 5-15 years old 
o Who have completed ≥1 year of school in US.  
o Who are able to safely attend outdoor sessions with one parent/guardian 
5.4 
Recruitment Procedures  
Our community partner, Elena’s Light, has identified eligible and interested families who are 
connected with their organization. Subjects will be asked by members of the community 
organization if they are interested in participation. For those who are interested, they will 
meet with the PI and collaborators over Zoom (with Zoom support provided as needed) for 
more information. Those who agree to participate will then undergo one-on-one Zoom 
sessions with the PI. Verbal informed consent in the participant’s preferred language (Dari, 
Farsi, Pashto, Arabic, or English) will be provided prior to initiation of study. 
 
5.5 
Consent/Assent Procedures/HIPAA Authorization 
Consent of parents and assent of children will be obtained by the PI and research assistants 
with a qualified interpreter. Consent will be obtained over Zoom with a verbal informed 
consent. Privacy will be assured by keeping all respondent information on password 
protected computers. Understanding of the study will be assessed through confirmation of 
understanding with the interpreter during the consent process. To avoid undue influence, 

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participants will be given options to withdraw at any time. Assurances will be provided that 
the EMPOWER curriculum is in no way connected to clinical care. 
 
• 
Consent forms describing in detail the study intervention, study procedures, and risks 
are given to the participant and written documentation of informed consent is 
required prior to starting procedures/administering study intervention.  
• 
Consent forms will be Institutional Review Board (IRB)-approved and the 
participant/legally authorized representative (LAR) will be asked to listen to our 
reading of and review of  the document. The research assistant and/or PI will be 
available to answer any questions that may arise. Conversations will occur over 
Zoom at the participants’ convenience. Privacy will be insured by allowing 
participants to choose time, location, and if they would like to use video or not. 
• 
Participants/LAR will have the opportunity to carefully review the verbal consent and 
will be offered a written version of the form and can ask questions prior to signing. 
The participants/LAR should have the opportunity to discuss the study with their 
family or surrogates or think about it prior to agreeing to participate. 
• 
Participants/LAR must be informed that participation is voluntary and that they may 
withdraw from the study at any time, without prejudice. A copy of the informed 
consent document will be given to the participants/LAR for their records. 
• 
One or two parents/legal guardians may participate in the consent process. 
• 
Assent will be obtained from child participants over Zoom. A verbal explanation in the 
child’s preferred language will be provided in terms suited to the participant's 
comprehension of the purposes, procedures, and potential risks of the study and of 
their rights as research participants. 
 
 
 
 
 
 

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6 Study Methods/Procedures 
6.1 
Study Procedures 
EMPOWER Curriculum: EMPOWER is an adapted SEL and wellness education initiative 
delivered to a community of refugee families that 
was developed through a pre-pilot in the New 
Haven Afghan refugee community in 2020. Unlike 
traditional school-based SEL curricula, 
EMPOWER partners with community 
organizations to provide translated and trauma-
informed wellness education to family units. The 
program combines in-person (socially distant) and 
remote delivery of culturally-informed physical, 
emotional, and medical wellness tools adapted 
from evidenced-based behavioral medicine, 
refugee trauma and recovery, and community 
health research (Table 2). Over two weeks, 
enrollees participate in six in-person sessions (two 
hours each). They also complete four, one-hour, 
weekly Zoom sessions during and beyond the in-
person curriculum. At-home Zoom technical 
support is provided as needed. Each family unit is 
guided through in-person and online components 
by a facilitator. The EMPOWER curriculum focuses on the core competency of self-
awareness, a core element of emotional competence, from the Collaboration for Academic 
Social and Emotional Learning (CASEL) framework.23 Facilitators include interns, health-
providers, and community partners. We have published a detailed EMPOWER manual, 
which we will iteratively modify, through an online request portal.24 
Intervention: We will use implementation science methods and apply an Intervention 
Mapping framework to refine and assess the adoption, acceptability, and feasibility of 
EMPOWER.18 The program will include virtual and in-person SEL, COVID-19 safety, and 
physical activity instructions. Program administrators will also respond to and track 
disclosure of and/or identification of mental health, medical, or other needs. 
Data Collection and Measures: We will conduct a mixed methods evaluation—using 
concurrent qualitative and quantitative data collection and merged analysis25—to survey 
parents and their children (over Zoom) at early and late time-points of their involvement in 
the program. Interview guides and survey tools will be developed with community partners 
and will be based upon previously-studied measures used for war-affected families.26 In 
addition to demographic covariates (age, gender, languages, years in the US), we will collect 
data and assess implementation outcomes as well as primary and secondary outcome 
measures (Table 1). Questions will be asked to parents about each child and to the children 
directly. 
Implementation measures (Aim 1) will include assessment of adoption, acceptability, and 
feasibility through parent and stakeholder evaluations and through rates of attrition. 
Outcome measures (Aim 2) will include (a) COVID-19 knowledge, measured via an 
established COVID-19 knowledge assessment17 and (b) children’s SEL competence, 
measured by the Trait Meta-Mood Scale.16 Secondary outcomes and covariates will include 
the validated measures outlined in Table 1 that may modify intervention effectiveness. While 
timeline and small sample size in this pilot will likely not allow detection of pre-post 
differences in quality of life or behavioral health concerns such as stress or depressive 
symptoms, we will examine patterns in secondary outcomes to form hypotheses in 
preparation for future, larger-scale trials. 
Table 2. EMPOWER Curricular Components  
Pre-EMPOWER Preparedness 
At Home: Consent Form Signed, Materials Delivered 
At Home: Zoom Support, Zoom Orientation with Parents 
Identification of Outdoor Space, Safe and Walkable 
In-Person Curriculum (6 times, over 2 weeks) 
COVID-19 symptom and temperature check 
Hand-washing, clean space, social distance 
Arrival art activity and materials provided 
Lesson: COVID-19 Safety (symptoms and prevention) 
Lesson: Physical Activity (eg breathing, yoga) 
Lesson: Healthy Habits (eg healthy eating) 
Lesson: SEL, Emotional Vocabulary (eg emotion bingo) 
Lesson: Art Activity (eg painting emotions) 
Wrap-Up: Homework, Breathing, Hand-Washing 
Zoom Curriculum (1 time weekly, over 4 weeks) 
Arrival: Mindfulness Exercises (eg 20 Questions) 
Lesson: COVID-19 Safety (symptoms and prevention) 
Breakout Lesson: Physical Activity (eg yoga) 
Breakout Lesson: Homework check-in  
Breakout Lesson: SEL, Emotional Vocabulary Games 
Wrap-Up: Homework, Next Meeting 

                                                                                                                       HIC # 2000030455 
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Intervention and Evaluation Schedule 
 
6.1.1 Data Collection 
After confirming verbal informed consent, data will be collected over Zoom with interpreters 
who speak the respondents’ preferred languages.  
• 
Translated Data Collection Instruments: Standardized data collection tools, which will 
be interpreted according to World Health Organization Standards include: 
o Trait meta mood scale16 
o Afghan symptom checklist20 
o Pediatric quality of life27 
o Perceived stress scale19  
o COVID-19 questionnaire,17 previously administered (uploaded in supporting 
documents) 
• 
Implementation Outcomes: A qualitative survey guide will be developed with 
stakeholders to discuss feasibility and acceptability with parents, based upon prior 
piloted survey tools (uploaded in supporting documents). 
• 
Mode of Data Collection: All surveys and interviews will be conducted over Zoom. 
After verbal informed consent is read in the respondent’s preferred language, with 
permission, responses will be audio-recorded. Interviews will be transcribed verbatim 
in real-time with post-interview proofreading and comparison to the audio recordings. 
It is expected that all interviews and surveys will be approximately one hour in 
duration. 
• 
Compensation: A $25 gift card will be distributed to respondents after each interview. 
All interviews were approximately one hour in duration.  
 
 
 
Info Session 
(All) 
 
Pre-
Evaluation 
(All) 
 
EMPOWER 
(for 
Intervention 
Group) 
Evaluation 
(Intervention) 
Evaluation 
(Control) 
 
EMPOWER 
(for Control 
Group) 
Zoom Information 
Session 
X 
 
 
 
 
Zoom Informed Consent 
 
X 
 
 
 
 
Demographic Collected 
 
X 
 
 
 
 
Outcome Evaluation 
COVID-19 Knowledge 
 
X 
 
X 
X 
 
Trait Meta Mood Scale  
 
X 
 
X 
X 
 
Secondary Outcomes:     
Afghan Symptom 
Checklist, PedsQL, 
PSC 
 
X 
 
X 
X 
 
Implementation 
Outcomes 
 
 
 
X 
 
 
EMPOWER Curriculum 
 
 
X 
 
 
X 

                                                                                                                       HIC # 2000030455 
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6.2 
Method of Assignment/Randomization (if applicable)  
Not applicable. Intervention and control group designations will be based upon geographic 
location to easily access the outdoor location of the EMPOWER program.  
 
6.3 
Adverse Events Definition and Reporting 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related.  
 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view 
of either the investigator or sponsor, it results in any of the following outcomes: death, a life-
threatening adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect.  
 
Any adverse event will be evaluated determined severity and need for reporting to IRB.  
 
6.4 
Reaction Management 
A referral network and network of experts in pediatric health, pediatric mental health, and 
adult refugee health have been compiled. If any medical, mental health, educational, or 
behavioral health needs are disclosed, patient navigators and the research team will ensure 
proper referrals and follow-up are followed. 
 
6.5 
Withdrawal Procedures 
Participants may withdraw at any time by letting staff know or stopping attendance, and if 
requested, no new data will be collected, but previously collected data will be kept to 
maintain the integrity of the study. 
 
6.6 
Locations/Facilities 
Locations will be secure, safe outdoor spaces near participants’ homes (including, for 
example, outdoor parks, or parking lots) identified by and with refugee serving organizations 
in Connecticut, USA. Additional curricula will occur over Zoom, as will all surveys and 
interviews. Additionally, the entire curriculum is fully convertible to Zoom if needed, and if 
weather and/or COVID necessitates remote learning, this can happen at any point in the 
protocol. 
 
 
 
 

                                                                                                                       HIC # 2000030455 
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7 Statistical Design 
 
7.1 
Sample Size Considerations 
Following COVID-19 protocols, we will limit in-person attendance to a maximum of ten 
children from a maximum of four family units over five sessions. Therefore, we anticipate 
about 50 children from 20 family units, with 25 children from 10 families as waitlist controls. 
This is well within recommended pilot sample size of 15-25 to detect small to medium effect 
sizes.28 
 
7.2 
Planned Analyses 
In this mixed methods study, we will perform concurrent qualitative and quantitative data 
collection and subsequent merged analysis. We will analyze quantitative data in Stata,29 with 
statistical support from a biostatistician. Qualitative responses will be transcribed and coded 
by members of the research teams using NVivo®. We will identify emerging themes using 
the constant comparative method. A repeated measures linear mixed model approach will 
be used for analysis. The primary analyses will compare changes in COVID-19 knowledge 
and of emotional competence before and after participation between the intervention and 
wait-list control groups. Similar analyses will be measured for secondary outcomes.  
 
7.2.1 Secondary Objective Analyses (if applicable) 
See above. 
 
7.2.2 Analysis of Subject Characteristics (if applicable) 
Descriptive demographic characteristics will include: age, gender, languages, years in the 
US. 
 
7.2.3 Interim Analysis (if applicable) 
N/A 
 
7.3 
Data Relevance 
The data collected will specifically answer the research question of: can an adaptation 
of an established Social-Emotional Learning (SEL) curriculum effectively improve Social-
Emotional wellness for refugee children and their families? By evaluating emotional 
competence and exploring secondary outcomes related to mental and behavioral health, we 
will be able to understand the impact of EMPOWER on refugee children’s health. 
 
7.4 
Data Coding 
We will use the constant comparative method to analyze themes in the qualitative data and 
iteratively refined the interview guide over the course of the interviews.30 A two-person 
coding team will analyze written transcripts using grounded theory methodology.30 

                                                                                                                       HIC # 2000030455 
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Discrepancies will be resolved by discussion, and the research team will then review codes 
and emerging themes and agreed upon trends and themes from qualitative responses. The 
mixed-method results will be integrated with merged analysis which compared and 
contrasted divergences.25 
 
7.5 
Data Analysis Tools 
Both Dedoose and Stata will be used in analysis. 
 
7.6 
Data Monitoring 
Data will be kept on a password protected computer of the PI and/or in Yale’s secure Box 
location.  
 
7.7 
Handling of Missing Data 
A biostatistical consultant will be part of the research team who can help to determine how to 
handle missing data, depending on quantity of missing data. We will consider dropping 
certain individual responses and/or imputation methodology depending on how much data is 
missing. 
  
 

                                                                                                                       HIC # 2000030455 
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8 Data/Specimen Handling and Record 
Keeping 
8.1 
Subject Data Confidentiality 
Participant confidentiality and privacy is strictly held in confidence by the participating 
investigators, their staff, and the sponsor(s)/funding agency. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence.  
All research activities will be conducted in as private a setting as possible. 
Representatives of the Institutional Review Board (IRB), regulatory agencies or study 
sponsor/funding agency may inspect all documents and records required to be maintained 
by the investigator for the participants in this study. The study site will permit access to such 
records. 
The study participant's contact information will be securely stored at each study site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by the reviewing IRB, Institutional policies, 
regulatory, or sponsor/funding agency requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored on password-protected Yale Box server. This will 
not include the participant's contact or identifying information. Rather, individual participants 
and their research data will be identified by a unique study identification number. The study 
data entry and study management systems used will be secured and password protected. At 
the end of the study, all study databases will be de-identified and archived at the password 
protected computer of the PI. 
Taping of Zoom conversations will be recorded, with permission. Transcriptions and audio 
files will not include participant’s demographic data and will also be kept on password 
protected Yale Box and Dedoose files. 
 
8.2 
Data Quality Assurance 
In order to maintain quality control, all researchers will follow and update the EMPOWER 
manual, available via request through an online server.24 Training of research assistants will 
include observed data collection sessions. 
 
8.3 
Data or Specimen Storage/Security 
As noted above, data will be deidentified with participant IDs, which will be indexed on the 
PI’s password protected computer. Deidentified data, which will include responses to 
validated instruments, transcripts and audio recordings without demographic data, will be 
stored on password-protected Yale Box. 
 
8.4 
Study Records 
The PI will be responsible for maintaining study records on a password protected computer. 
These records will include: 
• 
Documentation of informed consent  

                                                                                                                       HIC # 2000030455 
24 
• 
COVID symptom screening records (administered for in-person classes) and 
attendance records (for Zoom and in-person classes) 
• 
Participant identifier ID index 
Additional records will be kept on Yale secured box: 
• 
Audio recordings and transcripts without participant demographic data 
• 
Responses to all validated survey tools 
 
8.5 
Access to Source 
Source documents (all electronic word documents) will include all data collection materials 
completed over Zoom with families. Qualitative and quantitative responses will be compiled 
into Dedoose and Stata for analysis, respectively. Deidentified documents will be available in 
Yale Box, shared with co-investigators. Identifiable data will be kept on the PI’s password 
protected computer. 
 
8.6 
Retention of Records 
Records will be kept for at least 3 years on the PI’s password protected computer and 
indefinitely, or until the PI chooses to destroy it, in Yale Box. 
 
8.7 
Data and Safety Monitoring Plan  
We do not anticipate any adverse events. The principal investigator (PI) will monitor the 
data, assure protocol compliance, and conduct the safety reviews at least annually.  The PI 
evaluate whether the study should continue unchanged, require modifications, or close to 
enrollment.  Any Reportable Events (which are events that are serious or life-threatening and 
unanticipated (or anticipated but occurring with a greater frequency than expected) and 
possibly, probably, or definitely related) Unanticipated Problems Involving Risks to Subjects 
or Others will be reported to the IRB and any appropriate funding and regulatory agencies. 
Unanticipated Problems Involving Risks to Subjects or Others that may require a temporary 
or permanent interruption of study activities (if possible) with be reported, followed by a 
written report within 5 calendar days of my becoming aware of the event to the IRB and any 
appropriate funding and regulatory agencies.  The PI will apprise fellow investigators and 
study personnel of all UPIRSOs and adverse events that occur during the conduct of this 
research project.  The PI will report all UPIRSOs and adverse events that occur during the 
conduct of this research project to other applicable oversight bodies as required within 
applicable reporting timeframes. 
 
 
 

                                                                                                                       HIC # 2000030455 
25 
9 Study Considerations 
9.1 
Institutional Review Board (IRB) Review 
The protocol will be submitted to the IRB for review and approval. Approval of the protocol 
must be obtained before initiating any research activity. Any change to the protocol will 
require an approved IRB amendment before implementation.  The IRB will have final 
determination whether informed consent and HIPAA authorization are required.   
Study closure will be submitted to the IRB after all research activities have been completed.     
Other study events (e.g. data breaches, protocol deviations) will be submitted per Yale 
policies. 
 
9.2 
Research Personnel Training 
All individuals assisting with conduct of research will receive and/or have received human 
subjects research training. Community members have completed CITI human subjects 
research training. Research assistants will be involved in curriculum administration and data 
collection over Zoom, with training and oversight by the PI. 
 
9.3 
Study Monitoring  
The internal team will monitor the study. A research mentor will not be involved directly in 
study administration or evaluation but will provide oversight of accuracy and rigor of 
evaluation. The research mentor, Mona Sharifi MD MPH, will meet with the PI weekly and 
will review and contribute to all research products. 
 
9.4 
Unanticipated Problems and Protocol Deviations 
A protocol deviation is any noncompliance with the protocol. The noncompliance may be 
either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly. 
It is the responsibility of the site investigator to identify and report deviations within 10 
working days of identification of the protocol deviation. All deviations must be addressed in 
study source documents, reported to the study sponsor, and the reviewing Institutional 
Review Board (IRB) per their policies. 
Unanticipated problems involving risks to participants or others include, in general, any 
incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
Institutional Review Board (IRB)-approved research protocol and informed consent 
document; and (b) the characteristics of the participant population being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 

                                                                                                                       HIC # 2000030455 
26 
If the study team becomes aware of an unanticipated problem (e.g. data breach, protocol 
deviation), the event will be reported to the IRB by the PI contacting the IRB. 
The UP report will include the following information: 
Protocol identifying information: protocol title and number, PI's name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP; 
• 
A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline: 
• 
UPs will be reported to the IRB within ten days of the investigator becoming aware of 
the event. 
 
9.5 
Study Discontinuation 
The study would be discontinued if there were any concerns related to safety or efficacy by 
any members of the research team and/or the IRB and/or the study sponsor. 
 
9.6 
Study Completion 
Data analysis is expected to be complete around March 2023, and IRB will be notified upon 
completion. 
 
9.7 
Conflict of Interest Management Plan  
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
 All investigators will follow the applicable conflict of interest policies. 
9.8 
Funding Source 
This work is funded in part by the Academic Pediatrics Association, Yale University 
Department of Pediatrics and NIH/NCATS. 
9.9 
Publication Plan 
It is expected that the PI, Julia Rosenberg, will hold the primary responsibility for publishing 
the study results, with guidance from the funding agencies (listed above) and from her 
mentor in the Department of Pediatrics, Dr. Mona Sharifi. 

                                                                                                                       HIC # 2000030455 
27 
The PI of this proposal are committed to the open and timely dissemination of research 
outcomes. The data generated in this grant will be presented at national or international 
conferences and published in a timely fashion. All final peer-reviewed manuscripts that 
arise from this proposal will be submitted to the digital archive PubMed Central.  
 
The principal investigator will ensure that clinical trial(s) under the award are registered and 
results information is submitted to ClinicalTrials.gov as outlined in the policy and according 
to the specific timelines stated in the policy. The recipient institution has an internal policy in 
place to ensure that clinical trials registration and results reporting occur in compliance with 
policy requirements. The principal investigator will also be responsible for aggregate results 
reporting and AE reporting at the conclusion of the project. 
 
 
 
10 List of Tables 
 
Table 1. EMPOWER Outcome Measures, Instruments, and Respondents 
Implementation Outcome Measures (via Qualitative Evaluations): 
Feasibility 
Qualitative evaluation of parents’ challenges 
with feasibility. Community partner 
stakeholders will be involved in this analysis. 
Parents 
Attrition 
Participant attendance & reasons for absence 
Parents  
Parent and Child 
Acceptability 
Qualitative evaluation of (1) parents’ 
experiences (2) child completion of homework 
activities (3)  referrals (for parents and 
children) related to mental, emotional, 
physical or behavioral health 
Parents 
Primary Outcome Measures (via Pre- and Post-Tests): 
COVID-19 Knowledge 
Evaluation of Symptoms and prevention*17 
Parents & Children 
Social-Emotional 
Competence 
Trait Meta-Mood Scale*16 
Parents & Children 
Secondary Outcomes Measures and Covariates (via Pre- and Post-Tests): 
Quality of Life       
Pediatric Quality of Life Inventory (PEDS-QL)*  Parents & Children 
Stress 
Perceived Stress Scale (PSC)*19                        Parents & Children 
Depressive Symptoms 
Afghan Symptom Checklist (CBCL)‡20  
Parents & Children 
Social Problems 
Afghan Symptom Checklist (CBCL)‡20  
Parents & Children 
*To be translated according to World Health Organization Standards.22   ‡Pashto/Farsi translation available. 
Table 2. EMPOWER Curricular Components  
Pre-EMPOWER Preparedness 
At Home: Consent Form Signed, Materials Delivered 
At Home: Zoom Support, Zoom Orientation with Parents 
Identification of Outdoor Space, Safe and Walkable 
In-Person Curriculum (6 times, over 2 weeks) 
COVID-19 symptom and temperature check 
Hand-washing, clean space, social distance 
Arrival art activity and materials provided 
Lesson: COVID-19 Safety (symptoms and prevention) 
Lesson: Physical Activity (eg breathing, yoga) 
Lesson: Healthy Habits (eg healthy eating) 
Lesson: SEL, Emotional Vocabulary (eg emotion bingo) 

                                                                                                                       HIC # 2000030455 
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Lesson: Art Activity (eg painting emotions) 
Wrap-Up: Homework, Breathing, Hand-Washing 
Zoom Curriculum (1 time weekly, over 4 weeks) 
Arrival: Mindfulness Exercises (eg 20 Questions) 
Lesson: COVID-19 Safety (symptoms and prevention) 
Breakout Lesson: Physical Activity (eg yoga) 
Breakout Lesson: Homework check-in  
Breakout Lesson: SEL, Emotional Vocabulary Games 
Wrap-Up: Homework, Next Meeting