NCT04991467 A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 390 participants in total. It began in 2021-12-17 with a primary completion date of 2026-12.

Brief Summary

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

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 (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) 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 * Use of the Valera Health app or a smartphone health platform similar to the Valera app

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