About this trial

For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 (PSS)

Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in the 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)

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

CARE Program and Valera Application with care manager functionality
Behavioral
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.
Valera Application with care manager functionality
Behavioral
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.
CARE Program
Behavioral
Participant will take part in 12 week CARE program.
Valera Application
Behavioral
Participant will receive the Valera health application which will provide parent education materials.
CARE Program and Valera Application
Behavioral
Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials.

Treatment groups

390 Participants

are divided into 3 treatment groups

Group A: Parents of children receiving mental health treatment at MontefioreExperimental treatment 3 interventions

Group B: Parents of children being treated for autoimmune disorders at MontefioreExperimental treatment 3 interventions

Group C: Healthcare workers at MontefioreExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in Caregiver Perceived Stress

Change in Caregiver Perceived Stress will be assessed using the Perceived Stress Scale (PSS). The PSS is 10-item scale which measures the degree to which situations in one's life are appraised as stressful and serves as an assessment of overall stress. Participants provide responses on the PSS based on their perceptions of stress over the prior month. Items are scored on a 5-point Likert scale ranging from 0 ("Never") to 4 ("Very Often"), for an overall possible score of 0-40. Responses to the 4 positively worded items on the scale (Items 4, 5, 7, and 8) are reverse scored (e.g., 0=4 and 4=0). Higher overall scores are associated with greater perceived stress over the past month. For purposes of this study change from baseline will be assessed and positive scores are associated with increased perceptions of stress. Scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will be used to compare parental stress vs. baseline within each arm.

Time frame