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CARE Program + Valera App Interventions for Parenting Challenges During Coronavirus (CARE Trial)

N/A

Recruiting

Led By Vilma Gabbay, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

CARE Trial Summary

This trial looks at the psychological effects of the pandemic on caregivers in the Bronx and how it might impact their ability to care for their children.

Who is the study for?

This trial is for primary caregivers in the Bronx experiencing high stress, especially those working on-site at Montefiore Medical Center or patients in psychiatric and rheumatology clinics there. It includes grandmothers and aunts but excludes those with neurocognitive issues, serious psychiatric/substance use problems, active child abuse cases, non-Spanish/English speakers, or prior similar app users.Check my eligibility

What is being tested?

The study tests various combinations of the CARE Program and Valera Application to alleviate parental stress due to COVID-19. Some will use both tools with added care manager support; others will try each tool separately or combined without extra support.See study design

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal challenges related to parenting during the pandemic.

CARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived Stress

Secondary outcome measures

Beck Anxiety Index

Beck Depression Index

Beck Suicide Scale Inventory

+5 more

Other outcome measures

Alcohol Use Disorders Identification Test (Audit C)

COVID Impact Scale

Drug Abuse Screening Test

+15 more

CARE Trial Design

3Treatment groups

Experimental Treatment

Group I: Parents of children receiving mental health treatment at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .

Group II: Parents of children being treated for autoimmune disorders at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Group III: Healthcare workers at MontefioreExperimental Treatment3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor

287 Previous Clinical Trials

11,856,748 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,793 Previous Clinical Trials

2,693,992 Total Patients Enrolled

5 Trials studying Parenting

535 Patients Enrolled for Parenting

Vilma Gabbay, MDPrincipal InvestigatorAlbert Einstein College of Medicine

2 Previous Clinical Trials

560 Total Patients Enrolled

Media Library

CARE Program Clinical Trial Eligibility Overview. Trial Name: NCT04991467 — N/A

Parenting Research Study Groups: Parents of children receiving mental health treatment at Montefiore, Parents of children being treated for autoimmune disorders at Montefiore, Healthcare workers at Montefiore

Parenting Clinical Trial 2023: CARE Program Highlights & Side Effects. Trial Name: NCT04991467 — N/A

CARE Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04991467 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this trial in terms of participants?

"Affirmative. Clinicaltrials.gov reveals that the recruitment process for this clinical trial is currently underway, having first been registered on December 17th 2021 and lastly modified on September 16th 2022. 360 patients are being sought out from a single medical centre."

Answered by AI

What prerequisites must be met in order to join this clinical trial?

"Eligible candidates should have an existing diagnosis, and must be of age between 18 to 65 years. This clinical trial is trying to recruit a cohort of 360 patients in total."

Answered by AI

Is the age range for this research experiment restricted to those under 50 years old?

"The framework for this medical trial requires that candidates fall between the ages of 18 and 65. There are 191 trials catered to minors while 948 studies are being conducted on elderly patients."

Answered by AI

Is this investigation enrolling participants at the present time?

"Affirmative. According to the clinicaltrials.gov portal, this trial is actively seeking participants; it was initially posted on December 17th 2021 and most recently updated September 16th 2022. The study requires 360 individuals from a single site for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Vilma Gabbay 2021. "A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04991467.

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