RecruitingNot ApplicableNCT04991467

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


Sponsor

Albert Einstein College of Medicine

Enrollment

360 participants

Start Date

Dec 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a smartphone-based mental health and stress management program for parents and caregivers in the Bronx who are dealing with high levels of stress — particularly those caring for children with psychiatric or rheumatic conditions, or healthcare workers on the front lines. You may be eligible if: - You are a primary caregiver (parent, grandparent, aunt, etc.) with a moderate-to-high stress score on the Perceived Stress Scale (14 or above) - You are an active patient in Montefiore Medical Center's psychiatric or rheumatology clinic, or a frontline healthcare worker required to be on-site at Montefiore - You speak English or Spanish You may NOT be eligible if: - You have serious psychiatric or substance use problems that would prevent meaningful participation - You have an active child abuse case - You have cognitive difficulties that prevent you from using telehealth services - You already use the Valera Health app or a similar smartphone health platform Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCARE 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.

BEHAVIORALValera 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.

BEHAVIORALCARE Program

Participant will take part in 12 week CARE program.

BEHAVIORALValera Application

Participant will receive the Valera health application which will provide parent education materials.

BEHAVIORALCARE 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.


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT04991467


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