Parent-focused Support for Bronx Caregivers

This study is testing different ways to support caregivers in the Bronx who are experiencing stress, especially due to the COVID-19 pandemic. It's looking at the "CARE Program" (a 12-week program) and the "Valera Application" (a health app with educational materials and a way to connect with your child's treatment team). Some participants will get one or both of these interventions. You might be able to join if you are a primary caregiver in the Bronx, are at least 18 years old, and have a moderate level of stress. This includes caregivers of children with psychiatric conditions or autoimmune illnesses, and frontline healthcare workers. The study will measure changes in caregiver stress over 24 weeks to see how well these interventions work. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 390 participants. It will compare three groups: one receiving the CARE program, one receiving the Valera app, and one receiving both.
What's involved
You would participate in a 12-week CARE program and/or use the Valera health application. You would also complete surveys at enrollment, 6, 12, and 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after enrollment, with surveys at 6, 12, and 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04991467

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Albert Einstein College of Medicine
~367 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:CARE Program and Valera Application with care manager functionalityValera Application with care manager functionalityCARE ProgramValera ApplicationCARE Program and Valera Application

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Caregiver Perceived Stress
Measured over From Week 0 to Week 6, Week 12, and Week 24
Parenting
Covid19

NCT04991467

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Montefiore Medical Center

    The Bronx, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jonathan Alpert, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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)

Exclusion

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
  • Change in Caregiver Perceived StressFrom Week 0 to Week 6, Week 12, and Week 24

    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.