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

NCT04991467 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Parenting
  • Covid19

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Miami

    collaborator OTHER
  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Jonathan Alpert, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04991467 on ClinicalTrials.gov