RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-17
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04991467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All participants will be primary caregivers who present with moderate level of stress by meeting a severity score of ≥ 14 on the Perceived Stress Scale (PSS22).
  2. * Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in our patient population.
  3. * Clinical cohorts will be active patients in the psychiatric and rheumatology clinics in Montefiore Medical Center (MMC).
  4. * Frontline health care providers will be those who are required to work on site at Montefiore Medical Center (MMC).
  1. * Serious psychiatric or substance use difficulty that, in the judgement of the PI, would preclude meaningful participation in a parent intervention.
  2. * Active child abuse/maltreatment cases.
  3. * Neurocognitive conditions that may prevent participants from accessing telehealth services.
  4. * Primary language other than Spanish or English.
  5. * Utilized a smartphone health platform similar to the Valera app.

Contacts and Locations

Study Contact

Chloe Roske, AB
CONTACT
51668472019
chloe.roske@einsteinmed.edu

Principal Investigator

Vilma Gabbay, MD
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine

Study Locations (Sites)

PRIME
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Vilma Gabbay, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-17
Study Completion Date2026-03

Study Record Updates

Study Start Date2021-12-17
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • COVID
  • Parental Stress
  • Social Determinants of Health
  • Valera

Additional Relevant MeSH Terms

  • Parenting
  • Covid19