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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT04991467
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 17, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Parents of children receiving mental health treatment at Montefiore
    Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
  • Experimental: Parents of children being treated for autoimmune disorders at Montefiore
    Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
  • Experimental: Healthcare workers at Montefiore
    Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Primary Outcome Measure

Change in Caregiver Perceived Stress [ Time Frame: From Week 0 to Week 6, Week 12, and Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461
Maria Pondikos, BA
[email protected]
631-965-5095
Jonathan Alpert, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in The Bronx, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Montefiore Medical Center· The Bronx, NY

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