Actively Recruiting
A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Led by Albert Einstein College of Medicine · Updated on 2026-06-04
390
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on caregivers in the Bronx who are experiencing increased psychological distress due to the COVID-19 pandemic and related social challenges. It aims to evaluate how the CARE program and the Valera Health app can reduce this distress, improve access to healthcare, and support vulnerable caregivers, including those of children with psychiatric or autoimmune conditions and frontline healthcare workers. The study is a randomized controlled trial designed to assess these interventions' effects on caregiver stress, mood, anxiety, and healthcare engagement. Participants will be randomly assigned to one of three groups: the CARE program alone, the Valera Health app alone, or a combination of both. The CARE program involves 12 weekly one-hour group sessions lasting 12 weeks, while the Valera Health app offers parent education materials and connection to their child's treatment team. Smartphones and internet connectivity will be provided if needed to support participation. During the 24-week study period, caregivers will complete surveys at enrollment, 6 weeks, 12 weeks, and 24 weeks to measure perceived stress, reflective functioning, mood, anxiety, suicidality, and healthcare access. The study also explores how providing technology affects outcomes and uses machine learning to analyze various personal and social factors. The trial includes follow-ups and ongoing monitoring to understand the interventions' impact over time.
CONDITIONS
Brief Title
A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be primary caregivers with moderate stress, scoring 14 or higher on the Perceived Stress Scale
- Primary caregivers may include grandmothers, aunts, or others involved in caregiving
- Caregivers must be active patients in psychiatric or rheumatology clinics at Montefiore Medical Center, or frontline healthcare workers required to work onsite at Montefiore
- Participants must be able to speak English or Spanish and have access to telehealth services
- Participants must agree to participate in the 12-week CARE program and/or use the Valera Health app
You will not qualify if you...
- Serious psychiatric or substance use issues that prevent meaningful participation
- Active child abuse or maltreatment cases
- Neurocognitive conditions that limit access to telehealth services
- Primary language other than Spanish or English
- Current use of the Valera Health app or a similar smartphone health platform
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (phone screen)
Duration - 12 weeks
Participants take part in a 12-week CARE program and/or use the Valera Health app to support emotional health and access to healthcare. Group sessions last about one hour each and occur weekly.
12 weekly group sessions (approximately 1 hour each)
Duration - Up to 12 weeks after treatment
Participants complete surveys to assess stress, reflective functioning, healthcare access, mood, anxiety, and safety at multiple timepoints after treatment.
Surveys at 6, 12, and 24 weeks after enrollment
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
M
Maria Pondikos, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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