A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
CARE
2 other identifiers
interventional
360
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedStudy Start
First participant enrolled
December 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedSeptember 12, 2025
September 1, 2025
4.4 years
July 16, 2021
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Caregiver Perceived Stress
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 positively worded items on the scale (Items 4, 5, 7, and 8) are reverse scored (e.g., 0=4 and 4=0). Higher overall scores are associated with greater perceived stress over the past month. For purposes of this study change from baseline will be assessed and positive scores are associated with increased perceptions of stress. Scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will be used to compare parental stress vs. baseline within each arm.
From Week 0 to Week 6, Week 12, and Week 24
Secondary Outcomes (6)
Change in Parental Reflective Functioning (PRF) - Children
From Week 0 to Week 6, Week 12, and Week 24
Change in Parent Reflective Functioning (PRF) - Adolescent
From Week 0 to Week 6, Week 12, and Week 24
Change in Access to Healthcare
From Week 0 to Week 6, Week 12, and Week 24
Change in Depression
From Week 0 to Week 6, Week 12, and Week 24
Change in Anxiety
From Week 0 to Week 12, and Week 24
- +1 more secondary outcomes
Other Outcomes (20)
Change in Five Minute Speech Sample
From Week 0 to Week 6, Week 12, and Week 24
Change in Multidimensional Scale of Perceived Social Support
From Week 0 to Week 24
Change in Youth Outcome Questionnaire
From Week 0 to Week 24
- +17 more other outcomes
Study Arms (3)
Parents of children receiving mental health treatment at Montefiore
EXPERIMENTALParticipants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
Parents of children being treated for autoimmune disorders at Montefiore
EXPERIMENTALParticipants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Healthcare workers at Montefiore
EXPERIMENTALParticipants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Interventions
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.
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.
Participant will take part in 12 week CARE program.
Participant will receive the Valera health application which will provide parent education materials.
Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials.
Eligibility Criteria
You may qualify if:
- 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 (PSS)
- Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in the patient population
- Clinical cohorts will be active patients in the psychiatric and rheumatology clinics in Montefiore Medical Center (MMC)
- Frontline health care providers will be those who are required to work on site at Montefiore Medical Center (MMC)
You may not qualify if:
- Serious psychiatric or substance use difficulty that, in the judgement of the PI, would preclude meaningful participation in a parent intervention
- Active child abuse/maltreatment cases
- Neurocognitive conditions that may prevent participants from accessing telehealth services
- Primary language other than Spanish or English
- Use of the Valera Health app or a smartphone health platform similar to the Valera app
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albert Einstein College of Medicinelead
- National Institute of Mental Health (NIMH)collaborator
- University of Miamicollaborator
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Alpert, MD
Albert Einstein College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2021
First Posted
August 5, 2021
Study Start
December 17, 2021
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF