Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
Phase: NA
Conditions: Parenting, Stress, Learning Disabilities, Child, Attention Difficulties
Sponsor: Massachusetts General Hospital

Open Pilot Trial of a Resiliency Group Program for Caregivers of Children with Learning 
and Attentional Difficulties   
PI: Elyse Park, PhD MPH 
Study Protocol and Statistical Analysis Plan (English-language Version) 
Version Date: 3/3/25 
NCT06492278 
 

 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Elyse Park, PhD, MPH 
 
Project Title: 
 Open Pilot Trial of a Resiliency Group Program for Caregivers of Children with 
Learning and Attentional Difficulties   
 
Version Date: 
March 3, 2025 
 
 
Version Name/Number: 
4.0 
 
 
 
1. 
 Background and Significance 
 
Caregivers of children with LAD are a growing population, at risk for deleterious consequences of 
chronic stress. There is a growing population of children with LAD.1,2 Specific learning disabilities are 
characterized by difficulties understanding or in using spoken or written language, or difficulties with 
reading, writing, listening, speaking, reasoning, or math.3 Attentional disorders are characterized by 
difficulty with ongoing inattention and/or hyperactivity that interferes with functioning.4 Having a child 
with a learning and attentional disorder (LAD) presents distinct challenges and stressors which can impact 
the mental and physical health of parents. As such caregivers of children with LAD are a population in 
need of mind-body interventions targeted to improve resiliency and wellbeing.   
 
Caregivers of children with LAD experience more stress than those of neurotypical children, including 
heightened emotional distress that impacts the family.5 Qualitative interviews conducted with parents of 
children with LAD and professionals from advocacy and teaching organizations found high levels of 
parental stress, with primary stressors including navigating the educational system, social isolation, 
familial concerns, and financial and professional sacrifices. Stress was linked to emotional and physical 
exhaustion, social isolation, and strained familial relationships.6 Notably, high levels of parenting stress 
experienced by the parents of those with attentional disorders are associated with increased likelihood of 
parental psychopathology and maladaptive parenting practices, both of which directly impact the child’s 
wellbeing.5  
 
Modifiable resiliency skills leveraging growth enhancement may ameliorate the deleterious effects of 
chronic stress. Resilience is often characterized as a response to adversity; specifically, it refers to a set of 
protective factors and resources within an individual and their environment that facilitate one’s ability to 
“bounce back.” 7–14Resilience is demonstrated when one is able to maintain adaptive functioning while 
faced with ongoing chronic stress, as experienced by parents of children with LAD.10,15–18 
 
We have developed a mind-body program to enhance resiliency for individuals with chronic stress 
exposure. The SMART-3RP is an evidence-based group intervention, developed by our study team and 
colleagues at the Massachusetts General Hospital’s Benson-Henry Institute for Mind Body Medicine, to 
promote resilience and adaptation to stress.19 Program strategies integrate stress management principles 
from cognitive behavioral theory, positive psychology, and research on the relaxation response. 
Structured weekly sessions incorporate relaxation training, stress awareness, and adaptive strategies for 

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coping with stress and enhancing growth and wellbeing. Our study team and colleagues have tested the 
SMART-3RP model in diverse populations using in-person and telehealth modalities. This includes adults 
with specific medical conditions or life stressors as well as heterogeneous community cohorts. Results 
support that the intervention is feasible and acceptable, and may enhance resilience, coping and 
mood.15,20–23The SMART-3RP is an 8-session, approximately 90 minutes per week multimodal 
intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies 
for coping with stress.  
 
Outreach to vulnerable parent populations is needed. As parenting stressors are highest among parents 
from ethnic and racial minority status24, we have partnered with the Federation for Children with Special 
Needs (Federation) to carry out the proposed study aims. The Federation is a non-profit organization that 
provides information, support, and assistance to over 45,000 parents of children with disabilities annually; 
30% are parents of children with learning and attentional disabilities. The Federation oversees over 15 
projects related to supporting families who have educational needs in the state of Massachusetts which are 
targeted to assure equitable access to diverse families’ educational, medical, and community supports. 
Partnering with the Federation provides the opportunity to extend our work with underserved families and 
caregivers of color, low income, and rural parents of children with LAD via outreach through their 
website and affiliated social media (e.g., Facebook), listservs and webinars.  
 
Based on qualitative feedback from our recent English- and Spanish-language qualitative study 
conducted together with theFederation (MGB IRB # 2023P001820), we are refining the SMART-3RP 
and active control group (Health Education Program; HEP) to better fit the needs of parents of 
children with LAD. The goal of the present protocol is to gather preliminary data regarding the feasibility 
and acceptability of this refined protocol, as well as to gather pilot data regarding preliminary effect sizes 
and outcome measures, which will inform a future randomized pilot trial.  
 
Based on feedback from our qualitative study, we are also modifying the focus of our open pilot to increase 
cultural appropriateness and inclusivity to focus on the needs of individuals who identify as co-primary 
caregivers (i.e., inclusive of co-parents, guardians, or grandparents who hold significant caregiving 
responsibilities) of children with LAD. Another modification that we are making to the protocol based on 
feedback received from parents in the qualitative study phase is reducing session length to 60 minutes.  
 
2. 
Specific Aims and Objectives  
 
The proposed research has the following objectives:  
 
Aim 1 (Feasibility & Acceptability): Based on findings from our qualitative study (MGB IRB # 
2023P001820; Refining a Resiliency Program for Parents of Children with Learning and Attentional 
Disorders), the primary objective of this protocol is to conduct an open pilot to elicit initial quantitative 
and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and 
HEP) that we have refined. To do so, we will deliver our novel intervention to 4 groups of English- and 
Spanish-speaking parents of children with LAD (1 English-language SMART-3RP group, 1 English-
language HEP group; 1 Spanish-language SMART-3RP group, 1 Spanish-language SMART-3RRP 
group; approximate n up to 10 per group, approximate total N ~ 40) and collect qualitative and 
quantitative data regarding participants’ experiences in the trial. To inform plans for ongoing program 
refinement, we will also elicit specific feedback regarding study assessment tools, recruitment procedures, 
and group composition. Please see Table 1 for a listing of all feasibility and acceptability measures 
that we intend to assess. 
 

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Aim 2 (Exploratory Efficacy): Though this study is not intended to support a fully-powered test of 
intervention efficacy, we will explore clinical effect sizes for specific outcomes of interest to inform 
ongoing protocol refinement (i.e., intervention design and selection of relevant outcome measures). Our 
primary clinical outcome for these exploratory analyses is resiliency, assessed by the Current Experience 
Scale (CES). Secondary self-report outcomes are stress coping, depression/anxiety, worry mindfulness, 
social support, positive affect, empathy, fatigue, and healthy behaviors (healthy eating, physical activity, 
and sleep). Please see Table 1 for a listing of all study outcomes.  
 
In future, larger-scale, work, we intend to conduct a larger randomized pilot trial to assess intervention 
acceptability, feasibility, as well as preliminary efficacy on essential indices of sexual well-being.   
 
3. 
General Description of Study Design 
 
This will be a fully randomized open pilot trial enrolling up to 40 English- and Spanish-speaking co-
primary caregivers of children with LAD. To compare group remote delivery, participants will be 
assigned based on availability to either a mind-body resiliency group (SMART-LAD, intervention) or an 
evidence-based Health Education Program (HEP, control) which is a multiple behavior change program 
that addresses sleep, exercise, nutrition, substance use, and working with one’s healthcare team. Both the 
SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative 
study (MGB IRB # 2023P001820). There will be 4 pilot groups total- 2 for English-speaking co-primary 
caregivers of children with LAD (SMART and HEP) and 2 for Spanish-speaking co-primary caregivers of 
children with LAD (SMART and HEP). We will include up to 10 parents in each group. 
 
**The present submission only includes study documents for English-speaking parents, as we are 
awaiting final translations for Spanish-speaking parents from our certified translation service. We will 
submit these documents as an amendment as soon as they are available.  
 
4. 
Subject Selection 
 
Inclusion criteria: We aim to recruit English- speaking and Spanish-speaking co-primary caregivers (18+ 
years) of a child (< age 18) with LAD.  
 
Exclusion criteria: We will only exclude co-primary caregivers with significant psychiatric conditions (i.e., 
active suicidality or psychosis) or who are otherwise unable to participate, at the investigators’ clinical 
discretion. Only one caregiver per family can participate. Based on feedback from our community partner 
(Federation), we will exclude caregivers whose children have a primary diagnosis/disability other than a 
learning or attentional disorder; this decision was made based on clinical and professional observation that 
caregivers of children with primary learning and attentional disabilities have unique concerns from parents 
whose children receive supports for other diagnoses/disabilities.  
 
Parents who have participated in an earlier part of the study (i.e., qualitative protocol; MGB IRB # 
2023P001820) will also be excluded from participation.  
 
Screening for “Bots” and “Bad Actors.” To reduce the likelihood of responses from “bots” or “bad actors” 
who may misrepresent their eligibility in order to receive remuneration, we will also require all participants 
to provide a US phone number (not google voice or another internet service) where they can be reached by 
the study team. We may ask participants to provide greater detail or clarification regarding their children’s 
diagnosis to confirm veracity. Participants will be required to complete study procedures with “camera on” 
to confirm confidentiality and security for all group participants. We will follow best-practices for clinical 
research studies recruiting online, based on the recommendations of our MGH and DFCI colleagues.25  

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Diverse Recruitment. We emphasize outreach to underserved families and caregivers of color, low income, 
and rural families and fathers. 
 
Source of subjects and recruitment methods 
 
Initial proactive and reactive outreach. The Federation outreach specialists, along with the Federation 
Communications Coordinator, will reach out to caregivers using a variety of proactive and reactive 
recruitment techniques. This may include posting our study flyer (attached) on their website and affiliated 
social media (e.g., Facebook, Instagram, X), listservs, email lists (including SEPAC outreach), phone, 
email, and texting options. Study personnel from MGH and/or Federation may also attend in-person or 
live virtual informational events for caregivers of children with LAD, where they will provide 
information about the study and collect information from individuals interested in completing further 
screening for potential participation.  
 
Both MGH RA and Federation Human Subjects-approved staff contact information will be provided in all 
recruitment documents so that participants can choose the initial contact person with whom they feel most 
comfortable indicating interest. Postings on their affiliated social media (e.g. Facebook) will use the 
attached text describing the study, accompanied by an image of our study flyer. As in the attached 
recruitment text, social media posts will include contact info for the study investigators at Federation and 
MGH, should potential participants wish to learn more about the research. Recruitment posts on social 
media will disable chat and comment features in order to protect privacy.  
 
The Federation will also advertise the trial at Federation project workshops and support groups and via 
listservs and newsletters. The Federation has committed to working with local family advisors to support 
the sharing of information and to target outreach to diverse parent communities (e.g., underserved 
families and caregivers of color, low income, and rural communities). Please see example study flyers 
attached to this protocol, which may be used to share study information online and in person. As we are 
unfortunately not able to directly target recruitment of indigenous communities for this small pilot 
protocol, this research does not require any IRB review by Indian Health Service (IHS) and/or Tribal 
IRBs. 
 
Electronic survey for participants recruited via Internet (e.g., Facebook, listserv). Participants who learn 
about the study over the internet or via a study flyer, rather than via direct Federation staff referral, will be 
invited to complete an initial pre-screening survey in REDCap, linked via a QR code (see attached flyer). 
Following best practices for internet research25, we will include a combination of closed-and open-ended 
questions on this brief eligibility pre-screener in order to reduce incidence of “bots and bad actors.” 
Participants referred directly by Federation staff, community partners, or another direct medium may 
alternatively complete screening items via phone with a member of our study team.  
 
Engagement of our Community Partner (Federation) for Initial Eligibility Screening. As was the case for 
our Phase 1 qualitative study (MGB IRB # 2023P001820), we plan to include several Federation staff 
members as personnel on this protocol. As advised by MGB IRB staff, we plan to add Federation as a child 
site under this parent protocol following approval of the parent protocol. All Federation personnel included 
on the protocol will complete MGB-approved human-subjects training. Following approval, IRB-approved 
Federation staff will be available to answer initial study-related questions posed by interested parents and 
support initial pre-screening using our eligibility pre-screener in REDCap (see above). 
 
5. 
Subject Enrollment 
 

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Confirming Study Eligibility. The MGH study RA or another qualified team member (MGH and/or 
Federation staff) will follow-up and confirm eligibility with all interested participants who appear likely to 
be eligible based on the initial screening survey and document ineligibility and refusal information (see 
attached screening template).  
 
Spanish-speaking participants will be screened and consented by qualified Spanish-speaking study 
personnel in consultation with Drs. Giselle Perez and Dr. Esteban Barreto, both of whom are Native Spanish 
Speakers and Doctoral-level Clinical Scientists with experience doing clinical research in Spanish. The 
personnel will be study staff (e.g., MGH and/or Federation staff) with professional level Spanish, as 
assessed by members of the study team with native-level fluency. We do not anticipate needing Spanish-
language medical interpreters for this study. 
 
Procedures for obtaining informed consent: When eligibility is confirmed, the RA or another qualified 
team member will email and administer an electronic informed consent document using REDCap. 
Participants will provide an electronic signature on this document and will receive a final signed copy via 
postal mail or email, depending on their preference. This procedure will be conducted in either English or 
Spanish by qualified study staff (as above).  
 
At this point of initial informed consent, participants may also be asked if they would like to be contacted 
for: 1) future participation in studies conducted by this team and 2) participation on an advisory board 
whose goal is to provide feedback to our research team regarding program development for parents of 
children with LAD. The potential participant will be allowed to ask questions at this time. Participation 
will not be recorded in medical or employment records. Participants will be informed at the point of initial 
consent that we will audio-record all intervention sessions for fidelity; they will also be reminded of this 
at the start of the first intervention group, should they enroll. 
 
Parents will be informed that videoconferencing services and remote intervention will be provided by 
secure HIPAA-compliant videoconferencing software. In accordance with the HIPAA Privacy and Security 
Regulations, and to provide maximum security, research staff will send emails containing confidential 
information using encrypted email (Send Secure). Certain emails within low-risk category may be sent 
using non-encrypted methods, with participant permission. Non-encrypted emails will be sent upon 
participant request, with participant preference documented in our study records.  
 
At any point, eligible participants may opt out of enrollment. Reasons for refusal and ineligibility, among 
those who make contact, will be documented.  
 
6. 
STUDY PROCEDURES 
 
6.1: Group Assignment 
 
This is a single site pilot clinical trial of SMART-3RP versus HEP to intervene with caregivers of 
children with LAD. Participants who have completed the baseline survey will be assigned to treatment 
arm or group time according to availability. 
 
6.2: Intervention Structure and Content 
 
Interventionist expertise training. Both SMART-3RP and HEP groups will be led by qualified study 
staff with relevant clinical expertise. Dependent on staff availability, we may also include IRB-approved 
Federation staff members as group co-leaders together with MGB and Stony Brook personnel. Any 
Federation group co-leaders will attend a full-day training via videoconference, led by MGB and Stony 

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Brook faculty, to review the intervention manuals for SMART-3RP and HEP. Key elements of training 
include role-playing of various scenarios to practice skills delivery and facilitate learning. Weekly 
clinician meetings for personnel leading SMART-3RP and HEP groups will also include reviews of 
protocol fidelity, using audio recordings of intervention sessions. Brief descriptions of the SMART-3RP 
and HEP content, which is being refined based on our qualitative findings (MGB IRB # 2023P001820) 
are provided below: 
 
SMART-3RP: The intervention groups will be co-led by an MGB clinician with a possible (IRB-
approved) Federation co- leader with 8 weekly 1.5-hour session groups (approximate n = up to 10 parents 
per group). The intervention was created at the 8th grade reading level and 8 sessions focused on 3 
treatment components: 1) Eliciting the relaxation response (RR) involves sustained mental focus with an 
attitude of open receptive awareness. Techniques are aimed at reducing muscle tension and breathing rate. 
2). Cognitive-Behavioral Therapy (CBT) to improve stress awareness and management involves 
increasing awareness and identification of the components of one’s stress response (negative thoughts, 
emotions, physical reactions, behaviors, and relationships) and learning skills to alter these components 
(e.g., cognitive restructuring). 3) Positive psychology strategies to achieve growth enhancement focus on 
utilizing different techniques and skills to promote positive growth. Skills and exercises focus on 
increasing social support, acceptance, healthy behaviors (recuperative sleep, mindful eating, physical 
activity), positivity, humor, and appreciation. 
 
Health Education Program (HEP): The intervention groups will be co-led by an expert MGB or Stony 
Brook-based clinician with a possible (IRB-approved) Federation co- leader. The HEP was developed 
based on Multiple Health Behavior Change (MHBC) literature26 for individuals with co-occurring mental 
and physical health problems but can be adapted for a variety of different populations and applications. 
The components (1) education on the co-occurrence of mental and physical problems and healthy 
lifestyles; (2) goal setting for health behavior change; and (3) self-monitoring. Didactic, 
psychoeducational content was informed by national guidelines.27–31 Goal setting is based on the health 
behavior change framework (i.e., Specific, Measurable, Attainable, Relevant and Time-based).32 Self-
monitoring involves tracking health behaviors, and mood, anxiety, and stress symptoms.33 Topics in the 
educational component include physical activity, nutrition and healthy eating, sleep hygiene, alcohol and 
substance abuse, and managing healthcare.  
 
6.3: Data Collection 
 
Survey Data collection. We will administer surveys at 2 timepoints: approximately pre-intervention and 
approximately post-intervention. Surveys will be available in both English and Spanish, depending on 
participant preference, and they will take approximately 30 minutes each to complete. Participants can 
pause and go back to the survey later, with approximately 4 weeks allowed for completing each survey. 
Electronic links to complete study surveys may be sent via email and text on a secure REDCap link. If a 
parent prefers, surveys may be completed over the phone/Zoom with the MGH staff member. We may 
follow-up with participants who have not completed study surveys in entirety to request that they do so 
within approximately 4 weeks. We have selected appropriate participant-reported measures based on our 
prior studies and the resiliency intervention theoretical framework documenting resiliency, coping, and 
psychological distress. 34. We have prioritized brevity in selecting study surveys to reduce participant 
burden. All participant-reported study measures have strong psychometric properties with high internal 
and external validity and responsiveness to change.  
 
 
6.4: Participant Remuneration 
 
Participants will receive $20 per session attended (up to $160 for 8 sessions) and $20 for completing a 
post-group survey. Participants can receive up to a total of $180. A single-time payment will be made 

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according to parts of the study procedure that were completed (i.e. attendance at each study session and 
post-treatment survey). They will receive payment in the form of gift cards. 
 
6.5: Participant Communication with Study Team 
 
Participants will provide contact information to study staff and specify preferred contact modalities. Study 
staff may use phone and email to schedule group meetings and send study reminders. Study staff will 
explain the encrypted, “Send Secure” default feature of emails sent from within the Mass General Brigham 
network. Study staff will verify that no sensitive information will be disclosed in emails but ensure that the 
patient understands that by opting out of the send secure feature, information will not be as secure. 
 
7. 
Risks and Discomforts 
 
Participants may feel uncomfortable completing various questionnaires. As in any research study, there is 
a small risk that confidentiality may be breached; all efforts to minimize this risk will be taken. In 
addition, participants may find it time consuming to practice techniques learned in the intervention or 
tracking behavior such as elicitation the relaxation response. 
 
No participant will be required to participate, and personal information about decisions to participate will 
not be shared outside of the study team. Participation is voluntary for all subjects. In addition, all 
volunteer participants are allowed to withdraw at any point without any consequences.  Participants will 
be informed that they may refuse to answer questions that make them feel uncomfortable.  
 
Participant information will remain confidential unless there is a reasonable concern for risk of harm to self 
or others. When a group facilitator identifies acute emotional distress in a participant, the facilitator may 
offer the participant to take a break from the meeting or continue the meeting and may remind the participant 
that they can opt out of study procedures at any time.  The group facilitator will inform the study team (PI 
or designee) and discuss how to proceed further. If study staff identify concerns about a participant during 
study procedures outside of group intervention sessions (e.g., during reminder calls or other phone contact), 
the study team will contact the group facilitators to discuss how to proceed further.  We may recommend 
that a participant stop their study participation. Depending on the nature of the situation, the group 
facilitators may provide the participant with a clinical referral and/or contact appropriate authorities to 
ensure safety.  
 
8. 
Benefits 
 
Participants will be benefited by the exchange of information with colleagues and community members, 
which in turn has the potential to lead to an improvement and awareness in patient care. They may benefit 
from receiving information about strategies to enhance resiliency, stress management, and health. In 
addition, experts and parents may directly benefit from contributing to this project, because of their 
participation, care for parents and their children with learning and attentional disorders may be improved.  
 
9. 
Statistical Analysis 
 
Quantitative. Statistical significance will be considered as two-tailed p < .05. To explore feasibility of 
the adapted intervention, we will use descriptive statistics (i.e., frequency and percentages) to evaluate the 
proportion of enrolled participants who completed 6/8 intervention sessions (75%) in each study arm as 
well as additional feasibility indices listed in Table 1. To establish acceptability, we will examine 
participant scores on the Group Cohesiveness Scale (GCS-7).36 We will also include brief items 
addressing treatment satisfaction, for which our criteria for acceptability will require a Mean (or Median, 

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depending on data distribution) score > 4 on a 1-5 Likert scale from 1 (not at all) to 5 (extremely); see 
Table 1. These data will be interpreted holistically to identify areas for revision. 
 
Effect Sizes (Exploratory).  Although the intent of this open pilot trial is not to perform a fully-powered 
hypothesis test,37 we will conduct exploratory analyses of strength of change (i.e., effect sizes) in our 
primary outcome of interest (resiliency) as well as secondary outcomes (see Table 1). We will consider 
clinical improvements using within-person analysis of change from pre- (T0) to post-intervention (T1). 
Mixed effect multivariable models will be tested using the “lme4” package38  for R, which allows for use 
of all available data in the context of missingness.  
 
Table 1. Measures for Open Pilot Data Collection  
Construct 
Measurement 
Data Source  
Feasibility 
 
 
Access 
# of potentially interested 
participants identified through 
different recruitment sources 
REDCap, Recruitment tracking log 
Reach 
% of interested caregivers that 
are eligible, % of eligible 
caregivers that enroll and 
associated characteristics 
REDCap, Recruitment tracking log 
Treatment Delivery  
# of 1:1 remote sessions 
completed (6/8; 75% as criterion 
for completers)  
REDCap, tracking log 
Acceptability (Post-Intervention Only) 
Group Format  
Group Cohesiveness Scale-736 
Self-report in REDCap 
Assessment 
Overall satisfaction with 
program delivery, session # and 
length, program content, needs 
met, and helpfulness 
Self-report in REDCap (1 item each for 
total of 6 items) 
Sociodemographic Characteristics (Pre-Intervention only) 
Sociodemographic 
background 
1. Age; 2. Sex; 3. Gender 
identity; 4. Race; 5. Ethnicity; 6. 
Relationship Status; 8. 
Employment; 9. Education; 10. 
Language; 13. Religiousness; 
14; Spirituality; 15. Housing 
status; 16. Food insecurity; 17. 
Access to transportation; 18. 
Access to basic needs; 19. 
Ability to use technology 
Self-report in REDCap (19 items) 
Characteristics of 
Child with LAD 
1. Child age; 2. Diagnoses 
Self-report in REDCap (2 items) 
Primary Outcome (Pre- and Post-Intervention)  

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Resiliency  
Current Experience Scale 
(CES)34 
Self-report in REDCap (23 items) 
 
Secondary Outcomes (Pre- and Post-Intervention) 
Stress Coping 
Measure of Current Experience, 
Part A; ability to relax, recognize 
stress, elicit support, and 
restructure maladaptive 
thoughts39  
Self-report in REDCap (13 items) 
Depression & 
Anxiety 
Patient Health Questionnaire- 4 
items (PHQ-4); Anxiety and 
depression symptoms 40 
Self-report in REDCap (4 items) 
Mindfulness 
Cognitive and Affective 
Mindfulness Scale- Revised 
(CAMS-R); Mindfulness (e.g., 
present focus, emotional 
regulation)42 
Self-report in REDCap (10 items) 
Fatigue 
Fatigue; 0-10 Analog scale of 
fatigue44 
Self-report in REDCap (1 items) 
Positive Affect 
Positive and Negative Affect 
Schedule (PANAS-Pos); 
Measure of Positive Affect45 
Self-report in REDCap (10 items) 
Global Well-Being 
WHO-5 Well-Being Index46,47 
Self-report in REDCap (5 items) 
Social Connection 
PROMIS-Emotional Support 4a 
and PROMIS-Isolation 4a48 
Self-report in REDCap (1 item from 
each, 2 items total) 
Healthy Behaviors 
Mindful Eating Behaviors Scale 
(Hunger Cues and Eating with 
Awareness Subscales)49; 
Physical Activity Vital Sign, 
meeting weekly physical activity 
recs (150 mins of moderate-
rigorous)50; PROMIS Sleep 
Disturbance Short Form, 
assessment of sleep duration and 
quality51 
Self-report in REDCap (2 items- 
PROMIS Sleep Disturbance SF); Self-
report in REDCap (2 items- MEBS); 
Self-report in REDCap (2 items- PAVS) 
 
10. 
  Monitoring and Quality Assurance 

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As explicitly stated in study consent form, subjects may withdraw from participation at any time by 
notifying a member of the study team. Participants will not be required to provide a reason for 
withdrawal. Participants will also be reminded that they can withdraw from the group intervention 
programs at any point during their participation and may be offered the opportunity to continue 
completing study assessments (surveys) if appropriate.  
 
Electronic demographic information will be stored in REDCap, a secure and HIPAA-compliant web-based 
application hosted by the Mass General Brigham Research Computing Enterprise Research Infrastructure 
& Services group. The system offers data manipulation with audit trails, reports for monitoring and 
querying participant records, and an automated export mechanism to common statistical packages. REDCap 
data will be monitored weekly by study staff. 
 
Adverse Event Monitoring: Throughout the study participants will be monitored for occurrence of events 
defined as any undesirable experience or unanticipated risk. All adverse events will be reported on an 
adverse event form.  
 
The study PI is ultimately responsible for data and safety monitoring. If study staff becomes aware of any 
adverse events, the event will be reported immediately to the study PI. All adverse events and/or 
unanticipated problems will be reported by the PI to the Mass General Brigham IRB within 5 working days 
(7 calendar days) of the date the investigator first becomes aware of the unapproved deviation. Unapproved 
minor deviations will be recorded in a protocol-specific Minor Deviation Log. 
 
11. 
Data and Research Material Sharing 
 
11.1 
Sending Data/Materials to Research Collaborators outside Mass General Brigham 
 
Coded study data, including self-report data from REDCap surveys and aggregated program 
feedback provided by study participants, may be shared with IRB-approved research collaborators at 
Stony Brook and the Federation to inform collaborative efforts to refine the study interventions. We 
will remove identifiers from the dataset shared with non-MGB collaborators. Data will be coded 
according to participants’ study ID number with a key linking participants’ identifying information 
to study ID number kept in a password-protected file accessible only to MGB personnel with access 
to RISO-approved drives/cloud environments. We will share data with outside collaborators using 
encrypted email and/or MGB’s secure file transfer service. Stony Brook and the Federation 
personnel will only use de-identified study data for purposes described in this protocol. Should 
participants withdraw their data, we will notify the study team and ensure that data are appropriately 
removed from all study records based on coded ID number.   
 
We do not plan to share files containing recordings of study intervention groups with outside 
collaborators, though these may be reviewed remotely during study team meetings. Audio recording 
files will be stored to MGB’s RISO-approved drives/cloud environments for the purposes of 
protocol fidelity review. 
 
11.2 
Receiving Data/Materials from Research Collaborators outside Mass General Brigham 
 
We may receive contact information for potential study participants from our collaborators at the 
Federation. As outlined above, this information (e.g., name, phone, email address) will be sent 
securely via our MGB-hosted REDCap eligibility survey. 
 

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We do not expect to receive identifying study data from Stony Brook personnel. 
 
   
12. 
Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked 
files/areas) 
☒ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to another 
will be transported only in a secure manner (e.g. encrypted files, password protection, using 
chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers with 
coded data or specimens will be limited to the minimal necessary members of the research team 
required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☒ Additional privacy and/or confidentiality protections 
 
 
Study sessions will be conducted using Zoom, a secure, HIPAA compliant web-based videoconferencing 
platform. Recording is necessary for protocol fidelity. All group sessions will be password protected, and 
the password will only be shared with trained study staff, study participants, and group facilitators. We will 
also audio-tape group sessions. To further protect participant privacy, audio files will be labeled with group 
number and date as well as an identification code. All audio files will be transferred off of recorders onto a 
password protected MGB-hosted server (RISO-approved drive) immediately following each group. All 
audio files will be securely destroyed at the completion of the project.  
 
 
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