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

Study acronym: CARE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv16
  2. Minor Enrollment closed, study ongoing
    • Enrollment target: estimated 390 to confirmed 367
    • Site details revised
    v15
  3. Notable Primary and study completion dates: May 2026 to Dec 2026
    • Enrollment target: 360 to 390
    v14
  4. Notable Primary endpoints: 4 to 1v13 Show 6 more changesShow less
    • Primary and study completion dates: Mar 2026 to May 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 27 to 6
    • Study description expanded, about 16 words
    • Study site revised
    • Collaborators: 1 to 2
  5. Minor Primary and study completion dates: Mar 31, 2026 to Mar 2026
    • Site contact updated
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor 4 versions Re-verified since Aug 18, 2022, no change to tracked fieldsv8-v11
  2. Minor Site contact updatedv7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Secondary endpoints: 4 to 27
    • Site contact updated
    • Study title expanded, about 7 words
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Dec 17, 2021
    v4
  6. Notable Start date: Oct 2021 to Dec 2021v3
  7. Notable Start date: Aug 2021 to Oct 2021
    • Interventions: CARE Program (Behavioral), CARE Program and Valera Application (Behavioral), Parental Education (Behavioral), Parental Education and Valera… to CARE Program (Behavioral), CARE Program and Valera Application (Behavioral), CARE Program and Valera Application with care manager…
    • Study description shortened, about 91 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04991467
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Institute of Mental Health (NIMH), University of Miami
Conditions
(from sponsor)
Parenting, Covid19
Related terms COVID-19
Enrollment 367 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov