For caregivers in the Bronx, the pandemic has caused unprecedented psychologicaldistress; in addition to combating social determinants of health (SDOH), these familiesnow face greater financial insecurity and challenges related to their school-agedchildren. Furthermore, social distancing requirements and limited telehealth resourcesfor Bronx families have posed greater barriers to healthcare. Such parental distresscontributes to heightened risk of transgenerational cycles of psychological stress,trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic havehad significant consequences for family well-being, putting parents at higher risk ofexperiencing distress and potentially impairing their ability to provide supportive careto their children. Although children may be less susceptible to the most damagingphysical consequences of COVID-19, there are growing concerns regarding the short-andlong-term impacts of pandemic-related stressors on children. The marked upheaval offamily life over an extended period may make children vulnerable to mental healthconsequences associated with the public health crisis and infection mitigation efforts.School and childcare closures, unstable financial circumstances, social isolation andlack of support have a disproportionate, cumulative impact on parents and may underminetheir capacities to provide support for their children. Importantly, a large body ofevidence suggests that parental stress during times of disasters inducespsychopathologies in family members including children. Further, high anxiety anddepressive symptoms in parents during the pandemic have been associated with higher childabuse potential, whereas greater parental support was associated with lower perceivedstress and child abuse potential. In addition to psychological impacts, stress associatedwith caregiving can interfere with parents' ability to maintain their own health. Thismultimodal study addresses key strategies to mitigate the psychological and health impactof COVID-19 in parents.
Study Design
1. Objectives We hypothesize that both the CARE program and the Valera Health app will
mitigate the psychological effects of COVID-19 while enhancing access to healthcare
in the Bronx. The study will take place at Montefiore Medical Center (MMC), the
largest health system in the Bronx, serving predominantly racial and ethnic minority
individuals from underserved families. We will focus on three vulnerable caregiver
cohorts presenting with moderate stress: a) caregivers of children with psychiatric
conditions (N=130); b) caregivers of children with autoimmune illnesses (N=130); c)
caregivers who are frontline healthcare workers at MMC (N=130). While the latter may
have more favorable SDOH than families treated at MMC, this cohort has faced
unprecedented stress during the pandemic. A RCT (Stage III, NIH model) with 3 arms
will test our hypothesis: a) CARE program alone; b) Valera Health app; c) CARE
program and Valera Health app; Study procedures will include four surveys: at study
enrollment, 6-, 12- and 24-weeks and will assess parental stress (primary outcome),
reflective functioning (RF), access to healthcare, mood and anxiety and additional
parent and child clinical measures. Smartphones and connectivity will be provided as
needed.
Aim 1. To examine the efficacy of the 12-week CARE program on caregivers' emotional
health and RF. Hyp. 1. (a) Compared to the Valera Health app arm at 12- and 24-week
follow-up, participation in the CARE program will result in decreased caregiver's
perceived stress, increased RF, and improved caregiver's mood and anxiety symptoms.
(b) Therapeutic improvements in Hyp. 1a will be mediated by RF, as it reflects
mentalizing capacity.
Aim 2: To examine the efficacy of the 12-week Valera Health app on caregivers'
emotional health and access to healthcare. Hyp. 2. (a), The Valera Health app, will
result in decreased caregiver's perceived stress, increased access to healthcare,
and increased adherence to and engagement in treatment. (b) CARE program + Valera
Health app arm will be superior to CARE or Valera Health app alone on all outcome
measures.
Exploratory Aim: (a) We will also explore the effects on outcome of providing
technology and connectivity to families who lack them during the study period. (b)
We will explore the relative effectiveness of our intervention among the 3
vulnerable cohorts. (c) We will also utilize machine learning approaches to explore
complex patterns as predictors of outcome including COVID-19 illness/deaths, medical
comorbidity, psychopathology, housing, poverty, children's school status, age,
family functioning, and trauma.
2. Study Timelines
Individual Subject Timeline:
Participation in this research will last about 24 weeks. Participants will partake in 12
one hour group sessions that meet once per week. Participants will complete several
surveys when enrolled in the study and then after 6 weeks, after 12 weeks, and after 24
weeks.
Overall Timeline:
Because Investigators intend to rely on a pre-existing clinical infrastructure,
Investigators anticipate to be able to begin enrollment within the first six months of
the study. Participants will return for 6-month follow-ups. Data analysis will occur
throughout the duration of the study, along with publications and conference
presentations. The likelihood that this study will be carried out as planned is very
high, as all methods and collaborations are already in place.
Behavioral: CARE Program and Valera Application with care manager functionality
Participant will take part in 12 week CARE program and receive the Valera health
application which will provide parent education materials as well as the ability to
connect to their child's treatment team via care manager.
Behavioral: Valera Application with care manager functionality
Participant will receive the Valera health application which will provide parent
education materials and the ability to connect to their child's treatment team via care
manger.
Behavioral: CARE Program
Participant will take part in 12 week CARE program.
Behavioral: Valera Application
Participant will receive the Valera health application which will provide parent
education materials.
Behavioral: CARE Program and Valera Application
Participant will take part in 12 week CARE program and receive the Valera health
application which will provide parent education materials.
Inclusion Criteria:
- All participants will be primary caregivers who present with moderate level of
stress by meeting a severity score of ≥ 14 on the Perceived Stress Scale (PSS22).
- Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is
common in our patient population.
- Clinical cohorts will be active patients in the psychiatric and rheumatology clinics
in Montefiore Medical Center (MMC).
- Frontline health care providers will be those who are required to work on site at
Montefiore Medical Center (MMC).
Exclusion Criteria:
- Serious psychiatric or substance use difficulty that, in the judgement of the PI,
would preclude meaningful participation in a parent intervention.
- Active child abuse/maltreatment cases.
- Neurocognitive conditions that may prevent participants from accessing telehealth
services.
- Primary language other than Spanish or English.
- Utilized a smartphone health platform similar to the Valera app.
PRIME
Bronx, New York, United States
Investigator: Chloe Roske
chloe.roske@einsteinmed.edu
Investigator: Jonathan Alpert, MD
Chloe Roske, AB
51668472019
chloe.roske@einsteinmed.edu
Vilma Gabbay, MD, Principal Investigator
Albert Einstein College of Medicine