A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx (NCT04991467) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
United States367 participantsStarted 2021-12-17
Plain-language summary
For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on a parent-focused intervention in the Bronx for vulnerable populations affected by COVID-19 — given my specific situation and community, does my doctor think this kind of stress-reduction program could actually be a good fit for what I'm going through?
2Since the trial is no longer actively recruiting, is there any way to find out if a similar program or the same intervention has been made available outside of the study, perhaps through community health resources in the Bronx?
3The main thing being measured here is change in caregiver perceived stress — can my doctor help me understand whether addressing stress through a structured intervention like this would be a meaningful priority alongside any other mental health or medical support I might need?
4Because this trial is listed as Phase NA, meaning it may be more of a behavioral or community-based program than a drug trial, what does my doctor think about the general safety profile and what kinds of demands or commitments would a multimodal parent-focused program typically require from me week to week?
5Are there standard or established caregiver support programs already available to me that my doctor would recommend I explore first, while I look into whether this trial or a follow-up version of it might still be an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Caregiver Perceived Stress
Timeframe: From Week 0 to Week 6, Week 12, and Week 24