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

Not Applicable

Recruiting

• Conditions: Covid19; Parenting
• Interventions: Behavioral: CARE Program and Valera Application with care manager functionality; Behavioral: Valera Application with care manager functionality; Behavioral: Valera Application; Behavioral: CARE Program; Behavioral: CARE Program and Valera Application

• Registration Number: NCT04991467
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Detailed Description

Study Design

1. Objectives We hypothesize that both the CARE program and the Valera Health app will mitigate the psychological effects of COVID-19 while enhancing access to healthcare in the Bronx. The study will take place at Montefiore Medical Center (MMC), the largest health system in the Bronx, serving predominantly racial and ethnic minority individuals from underserved families. We will focus on three vulnerable caregiver cohorts presenting with moderate stress: a) caregivers of children with psychiatric conditions (N=130); b) caregivers of children with autoimmune illnesses (N=130); c) caregivers who are frontline healthcare workers at MMC (N=130). While the latter may have more favorable SDOH than families treated at MMC, this cohort has faced unprecedented stress during the pandemic. A RCT (Stage III, NIH model) with 3 arms will test our hypothesis: a) CARE program alone; b) Valera Health app; c) CARE program and Valera Health app; Study procedures will include four surveys: at study enrollment, 6-, 12- and 24-weeks and will assess parental stress (primary outcome), reflective functioning (RF), access to healthcare, mood and anxiety and additional parent and child clinical measures. Smartphones and connectivity will be provided as needed.

Aim 1. To examine the efficacy of the 12-week CARE program on caregivers' emotional health and RF. Hyp. 1. (a) Compared to the Valera Health app arm at 12- and 24-week follow-up, participation in the CARE program will result in decreased caregiver's perceived stress, increased RF, and improved caregiver's mood and anxiety symptoms. (b) Therapeutic improvements in Hyp. 1a will be mediated by RF, as it reflects mentalizing capacity.

Aim 2: To examine the efficacy of the 12-week Valera Health app on caregivers' emotional health and access to healthcare. Hyp. 2. (a), The Valera Health app, will result in decreased caregiver's perceived stress, increased access to healthcare, and increased adherence to and engagement in treatment. (b) CARE program + Valera Health app arm will be superior to CARE or Valera Health app alone on all outcome measures.

Exploratory Aim: (a) We will also explore the effects on outcome of providing technology and connectivity to families who lack them during the study period. (b) We will explore the relative effectiveness of our intervention among the 3 vulnerable cohorts. (c) We will also utilize machine learning approaches to explore complex patterns as predictors of outcome including COVID-19 illness/deaths, medical comorbidity, psychopathology, housing, poverty, children's school status, age, family functioning, and trauma.

2. Study Timelines

Individual Subject Timeline:

Participation in this research will last about 24 weeks. Participants will partake in 12 one hour group sessions that meet once per week. Participants will complete several surveys when enrolled in the study and then after 6 weeks, after 12 weeks, and after 24 weeks.

Overall Timeline:

Because Investigators intend to rely on a pre-existing clinical infrastructure, Investigators anticipate to be able to begin enrollment within the first six months of the study. Participants will return for 6-month follow-ups. Data analysis will occur throughout the duration of the study, along with publications and conference presentations. The likelihood that this study will be carried out as planned is very high, as all methods and collaborations are already in place.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-05
• Study Start: 2021-12-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-28
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 (PSS22).
• Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in our 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).

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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.
• Utilized a smartphone health platform similar to the Valera app.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Parents of children being treated for autoimmune disorders at Montefiore	CARE Program and Valera Application with care manager functionality	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Parents of children receiving mental health treatment at Montefiore	CARE Program	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
Healthcare workers at Montefiore	CARE Program	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Parents of children receiving mental health treatment at Montefiore	CARE Program and Valera Application with care manager functionality	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
Parents of children receiving mental health treatment at Montefiore	Valera Application with care manager functionality	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
Parents of children being treated for autoimmune disorders at Montefiore	CARE Program	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Parents of children being treated for autoimmune disorders at Montefiore	Valera Application with care manager functionality	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Healthcare workers at Montefiore	Valera Application	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
Healthcare workers at Montefiore	CARE Program and Valera Application	Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Primary Outcome Measures

Name	Time	Method
Perceived Stress	week 24	Perceived Stress Questionnaire Change

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Index	week 24	BAI Change
Beck Depression Index	week 24	BDI change
Parental Reflective Functioning Questionnaire- Child	week 24	Parental Reflective Functioning Questionnaire Change
Parental Reflective Functioning Questionnaire-Child	week 12	Parental Reflective Functioning Questionnaire Change
Five Minute Speech Sample	week 24	FMSS Change
Beck Suicide Scale Inventory	week 24	BSSI Change
Parent Stress Index	week 24	PSI-4 change
Parent Reflective Functioning Questionnaire-Adolescent	week 24	Parental Reflective Functioning Questionnaire change

Trial Locations

Locations (1)

PRIME; 🇺🇸 Bronx, New York, United States