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NCT04991467 · ClinicalTrials.gov registry record · NA

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

A NA study of COVID-19 and Parenting, sponsored by Albert Einstein College of Medicine.

Recruiting
Registry status
NA
Development phase
360
Enrollment target
1
Study location

NCT04991467: Recruiting NA study of COVID-19 and Parenting, sponsored by Albert Einstein College of Medicine.

NCT04991467 is a NA study of COVID-19 and Parenting that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 360 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04991467, a NA study of COVID-19 and Parenting, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.

RECRUITING
Registry status
NA
Development phase
360 participants
Enrollment target
1
Study location

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

Primary Outcome

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

Conditions Studied

Interventions

  • BEHAVIORAL CARE Program and Valera Application with care manager functionality
  • BEHAVIORAL Valera Application with care manager functionality
  • BEHAVIORAL CARE Program
  • BEHAVIORAL Valera Application
  • BEHAVIORAL CARE Program and Valera Application

Study Locations (1)

New York

  • Montefiore Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2021-12-17
Est. Completion 2026-05
Phase NA
Albert Einstein College of Medicine

175 total trials

What NCT04991467 shows while recruiting

NCT04991467 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which CARE Program and Valera Application with care manager functionality is the first listed.

NCT04991467 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04991467 about?

NCT04991467 is a clinical study titled "A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx". 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 requirem...

What is the current status of trial NCT04991467?

This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2021-12-17. Estimated completion is 2026-05.

What conditions does trial NCT04991467 study?

This clinical trial studies the following conditions: COVID-19, Parenting.

What interventions are being tested in trial NCT04991467?

The interventions under investigation include: CARE Program and Valera Application with care manager functionality (BEHAVIORAL), Valera Application with care manager functionality (BEHAVIORAL), CARE Program (BEHAVIORAL), Valera Application (BEHAVIORAL), CARE Program and Valera Application (BEHAVIORAL).

Who is sponsoring clinical trial NCT04991467?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04991467 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04991467's enrollment target sits among peer trials

360 131st of 298 higher than 168 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04991467, the US trial registry maintained by the National Library of Medicine. NCT04991467 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.