Study 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.
Eligible Conditions
- Parenting
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: week 24
week 0
Philadelphia ACE
RaLES-B
week 12
Multidimensional Scale Of Perceived Social Support
Parental Reflective Functioning Questionnaire-Child
week 24
Alcohol Use Disorders Identification Test (Audit C)
Beck Anxiety Index
Beck Depression Index
Beck Suicide Scale Inventory
COVID Impact Scale
Drug Abuse Screening Test
Family Assessment Device-General Functioning Scale
Five Minute Speech Sample
Health Related Quality of Life
Kansas Parental Satisfaction Scale
Life Events Checklist
Multidimensional Assessment of Parenting Scale (MAPS)
Multidimensional Scale of Perceived Social Support
Multidimensional assessment of emotion regulation and dysregulation
PC-PTSD COVID
PROMIS EARLY CHILDHOOD
PROMIS Parent Proxy Scale
Parent Reflective Functioning Questionnaire-Adolescent
Parent Stress Index
Parental Reflective Functioning
Parental Reflective Functioning Questionnaire- Child
Perceived Stress
Treatment and Health Behavior Questionnaire
Youth Outcome Questionnaire
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Healthcare workers at Montefiore
1 of 3
Parents of children receiving mental health treatment at Montefiore
1 of 3
Parents of children being treated for autoimmune disorders at Montefiore
1 of 3
Experimental Treatment
360 Total Participants · 3 Treatment Groups
Primary Treatment: CARE Program · No Placebo Group · N/A
Healthcare workers at MontefioreExperimental Group · 3 Interventions: CARE Program and Valera Application, CARE Program, Valera Application · Intervention Types: Behavioral, Behavioral, Behavioral
Parents of children receiving mental health treatment at MontefioreExperimental Group · 3 Interventions: Valera Application with care manager functionality, CARE Program and Valera Application with care manager functionality, CARE Program · Intervention Types: Behavioral, Behavioral, Behavioral
Parents of children being treated for autoimmune disorders at MontefioreExperimental Group · 3 Interventions: Valera Application with care manager functionality, CARE Program and Valera Application with care manager functionality, CARE Program · Intervention Types: Behavioral, Behavioral, Behavioral
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 24
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
265 Previous Clinical Trials
1,838,906 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,555 Previous Clinical Trials
1,822,025 Total Patients Enrolled
6 Trials studying Parenting
629 Patients Enrolled for Parenting
Vilma Gabbay, MDPrincipal InvestigatorAlbert Einstein College of Medicine
2 Previous Clinical Trials
560 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Investigators will allow primary caregivers to attend the study visits, as it is common in our patient population.
The clinical cohorts will consist of active patients who are currently receiving treatment at the psychiatric or rheumatology clinics at Montefiore Medical Center.
Participants in the study will be primary caregivers who display moderate levels of stress, as measured by their score on the Perceived Stress Scale (PSS), which is ≥ 14.
The frontline health care providers at Montefiore Medical Center (MMC) will be those who are required to work on site.
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Conditions
Cancer Related
Treatments