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Bronx parents get help to beat pandemic stress in new study

NCT ID NCT04991467

Symptom relief Sponsor: Albert Einstein College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study is for primary caregivers in the Bronx who feel stressed. It tests a 12-week program called CARE, plus a phone app (Valera) that gives parenting tips and connects families to a care manager. The goal is to see if these tools can lower stress and help parents support their children better. About 390 caregivers will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CARE Program and Valera health application
What this could lead to
If successful, this could provide a practical way to reduce parental stress and improve mental health support for families in underserved communities.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results may vary based on individual participation. The study is still recruiting and outcomes are based on self-reported stress levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

367 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID19 Parenting

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.